Document 3Q29yJ7z319B9LgOZgDkQjgOa

tFMrecher'ie AR226-3140 CONFIDENTIAL SPONSOR Elf Atochem SA. Cours Michelet La Dfense 10 92091 Paris-la-Dfense CEDEX France TEST SUBSTANCE _ STUDY TITLE ACUTE DERMAL IRRITATION IN RABBITS STUDY DIRECTOR Xavier Manciaux STUDY COMPLETION DATE 13 December 1999 PERFORMING LABORATORY err Centre International de Toxicologie BP 563 - 27005 Evreux - France Company Sanitized. Does not contain TSCA CBl LABORATOR Y STUDY NUMBER 18746 TAL CENTRE INTERNATIONAL DE TOXICOLOGIE B. R 563 27005 Evreux Cedex France CIT/StudyNo. 18746 T 2 CONTENTS STATEMENT OF THE STUDY DIRECTOR 4 OTHER SCIENTISTS INVOLVED IN THIS STUDY 4 STATEMENT OF QUALITY ASSURANCE UNIT 5 SUMMARY 6 RESUME 8 1. INTRODUCTION 10 2. MATERIALS AND METHODS 10 2.1 TEST SUBSTANCE 2.1.1 Identification 2.1.2 Formulation procedure 2.2 TEST SYSTEM 2.2.1 Animals 2.2.2 Environmental conditions 2.2.3 Food and water 2.3 TREATMENT 2.3.1 Preparation and selection of the animals 2.3.2 Study design 2.3.3 Application of the test substance 2.3.4 Chronology of the study 2.4 CUTANEOUS EXAMINATIONS 10 10 10 11 11 . 11 11 12 12 12 12 12 12 2.5 DESCRIPTION AND EVALUATION OF CUTANEOUS REACTIONS 13 2.6 INTERPRETATION OF. RESULTS AND CLASSIFICATION OF SUBSTANCES . 2.6.1 Interpretation of the results 2.6.1.1 Criteria for irritation 2.6.1.2 Criteria for corrosion 2.6.2 Classification of the test substances 2.6.2.1 Irritant substances 2..2.2 Corrosive substances . 2.7 PROTOCOL ADHERENCE 13 13 13 13 14 14 14 14 2.8 ARCHIVING 15 3. RESULTS 4. CONCLUSION 16 iQS no! contain TSCfcCM gpmpany Sanitised- Q 16 CIT/Study No. 18746T, 33 Table 1: Individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for the first animal (application for 3 minutes) Table 2: Individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal (application for 4 hours) 17 18 APPENDICES 1. Test article description and analytical certificate 2. Diet formula 19 20 23 and 24 Company Sanitised- Dcea not contain TSCA CBI CIT/Study No. 18746 T 4 STATEMENT OF THE STUDY DIRECTOR The study was performed in compliance with the principles of Good Laboratory Practice as described in: . OECD Principles on Good Laboratory Practice (as revised in 1997), ENV/MC/CHEM (98) 17. . Dcret N 90-206 du 7 mars 1990 concernant les Bonnes Pratiques de Laboratoire (Journal Officiel du 9 mars 1990), Ministre de l'Industrie et de l'Amnagement du Territoire. . Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations or administrative provisions relating to the application of the Principles of Good Laboratory Practice and the verification of their applications for tests on chemical substances (OJ N. L 15 of 17.1.87). I declare that this report constitutes a true and faithful record of the procedures undertaken and the results obtained during the performance of the study. This study was performed at CIT, Centre International de Toxicologie, BP 563, 27005 Evreux, France. Toxicology X. Manciaux Study Director Doctor of Pharmacy Date: 13 December 1999 OTHER SCIENTISTS INVOLVED IN THIS STUDY For Pharmacy: P.O. Guillaumat . Doctor of Pharmacy For Toxicology: C. Pelcot Study Supervisor 1contain TSCA CBl C om panySanitize^- Does no CIT/StudyNo. 18746 T 35 STATEMENT OF QUALITY ASSURANCE UNIT Type of inspections Protocol Report Dates Inspections 4 June 1999 10 November 1999 Reported to Study Director (*) 4 June 1999 1 December 1999 Reported to Management (*) 4 June 1999 1 December 1999 In addition to the above-mentioned inspections, at about the same time as the study described in the present report, "process-based" and routine facility inspections of critical procedures relevant to this study type were also made by the Quality Assurance Unit. The findings of these inspections were reported to the Study Director and to CIT Management. The inspections were performed in compliance with CIT Quality Assurance Unit procedures and the Good Laboratory Practice. The reported methods and procedures were found to describe those used and the results to constitute an accurate and complete reflection of the study raw data. L. Valette-Talbi Date: 13 December 1999 Doctor of Biochemistry Head of Quality Assurance Unit and Scientific Archives (*) The dates indicated correspond to the dates of signature of audit reports by Study Director and Management. noi contain TSCA CBl SUMMARY At the request of F.lf ^tnchem Paris-la-Defense. France, the potential of the test substance j t o induce skin irritation was evaluated in rabbits 'according to OECD (No. 404, 7th July 1992) and EC (92/69/EEC, B.4, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Methods The study design was established according to available information on the test substance and the above guidelines. In the First instance, the test substance was applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. Since the test substance was not severely irritant on this first animal, it was then applied for 4 hours to two other animals. A single dose of 0.5 ml of the undiluted test substance was applied to the closely-clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions. The mean values of the scores for erythema and oedema were calculated for each animal. Results After a 3-minute exposure (one animal): No cutaneous reactions were observed. After a 4-hour exposure (three animals): A very slight erythema was noted in all animals from day 1 or 2, up to day 4. Dryness of the skin was recorded in one animal on days 4 and 5. No other cutaneous reactions were observed during the study. Mean scores over 24, 48 and 72 hours for each animal were 1.0, 1.0 and 1.0 for erythema and 0.0,0.0 and 0.0 for oedema. Company Sanitised. Does not contain TSCA C31 CIT/Study No. 18746 T 7 Conclusion Under our experimental conditions, the test substance| slightly irritant when applied topically to rabbits. However, according to the classification criteria laid down in Commission Directive 93/21/EEC (27th April 1993) adapting to technical progress for the eighteenth time Council Directive 67/548/EEC, the test substance was considered non-irritant. r,0l contain TSC&CBI CIT/StudyNo. 18746 TA 8 RESUME A la demande de Elf Atochem S.A., Paris-la-Dfense, France, les proprits irritantes du produit t application cutane ont t values chez le Lapin (n 404, 17 juillet 1992) et de la CEE (92/69/EEC, B.4, 31 juillet 1992). L'tude a t ralise conformment aux rgles de Bonnes Pratiques de Laboratoire. Mthode L'tude a t ralise selon les informations disponibles sur le produit et les lignes directrices mentionnes ci-dessus. Dans un premier temps, le produit a t appliqu pendant 3 minutes et 4 heures sur 1 seul lapin mle New Zealand White. Le produit n'tant pas fortement irritant sur ce premier animal, il a ensuite t appliqu pendant 4 heures sur 2 autres animaux. Une dose unique de 0,5 ml de produit non dilu a t applique sur une surface de peau tondue d 'un des flancs. Le produit a t maintenu en contact avec la peau au moyen d'un pansement semi-occlusif. Les ractions cutanes ont t observes environ 1 heure, 24, 48 et 72 heures aprs l'enlvement du pansement puis quotidiennement jusqu' rversibilit des lsions cutanes. La moyenne des scores a t calcule pour l'rythme et pour l'oedme pour chaque animal. Rsultats Aprs une exposition de 3 minutes fl animal) : Aucune raction cutane n'est observe pendant l'tude. Aprs une exposition de 4 heures (3 animaux) : ' Un rythme trs lger est not chez tous les animaux du jour 1 ou 2, jusqu'au jour 4. Une scheresse cutane est observe chez 1 animal les jours 4 et 5. Aucune autre raction cutane n'est enregistre au cours de l'tude. Les scores moyens calculs pour chaque animal aprs 24, 48 et 72 heures sont de 1,0; 1,0 et 1,0 pour l'rythme et de 0,0 ; 0,0 et 0,0 pour l 'oedme. CBl CIT/Study No. 18746 T 9 Conclusion Dans nos conditions exprimentales, le produi lgrement irritant par voie cutane chez le La] st considr Cependant, selon les critres de classification dcrits dans la Directive 93/21/CEE (27 avril 1993) portant dix-huitime adaptation au progrs technique de la Directive 67/548/CEE, le produit est considr non irritant. ,, . . ,, - a D o ssr._ic.ocop wntLa.i_n_T--S--C--A--.... ............ CIT/StudyNo. 18746 T, 0 10 1. INTRODUCTION The objective of this study was to evaluate the potential of the test substance to induce skin irritation following a single topical application to rabbits. In the assessment of the toxic characteristics of a test substance, determination of the irritant and/or corrosive effects on the skin of mammals is an important initial step. Information derived from this test serves to indicate the possible hazards likely to arise from exposure of the skin to the test substance. This study was conducted in compliance with: . OECD guideline No. 4 0 4 ,17th July 1992, . EC Directive No. 92/69/EEC, B.4, 31st July 1992. 2. MATERIALS AND METHODS 2.1 TEST SUBSTANCE 2.1.1 Identification The test substance used in the study was supplied by Elf Atochem S.A. The test substance was identified as follows: . name: - protocol and labelling! . batch number - protocol and labelling^ . Elf Atochermrufuilinegnnuummobeer! . description! . container oned^pIlastic nask . date of receipt: 5 May 1999 . storage conditions: at room temperature and protected from light . expiry date: May 2000. Data relating to the characterization of the test substance are documented in a test article description and an analytical certificate (presented in appendix 1) provided by the Sponsor. The pH of the test substance, as specified by the Sponsor, was 5. 2.1.2 Formulation procedure The test substance was used undiluted. , j nnSS_ n-'t contai*1TSCAcB' CIT/Study No. 18746 T 11 2.2 TEST SYSTEM 2.2.1 Animals Sex, species, strain: male New Zealand White rabbits. Reason for this choice: species generally accepted by regulatory authorities for this type of study. Breeden Elevage des Dombes, 01400 Chtillon-sur-Chalaronne, France. Number of animals: three animals were used, as recommended by the international guidelines. Identification: the animals were identified individually with a metal ear tag. Weight: on the day of treatment, the animals had a mean body weight standard deviation of 2.6 0.1 kg. Acclimatization: at least 5 days before the beginning of the study. 2.2.2 Environmental conditions The conditions in the animal room were set as follows: . temperature: 18 3C . relative humidity: 30 to 70% . light/dark cycle: 12 h/12 h . ventilation: approximately 12 cycles/hour of filtered, non-recycled air. The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals. The animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle. 2.2.3 Food and water During the study, the animals had free access to 112 C pelleted diet (UAR, 91360 Villemoissonsur-Orge, France). Each batch of food was analysed by the supplier for composition and contaminant levels. The diet formula is presented in appendix 2. Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are performed regularly by external laboratories. . The results of these analyses are archived at CIT. No contaminants were known to have been present in the diet or drinking water at levels which may be expected to have interfered with or prejudiced the outcome of the study. goes not contain TSCACBl CIT/StudyNo. 18746 T, 12 23 TREATMENT 2.3.1 Preparation and selection of the animals The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined. Only animals with healthy intact skin were used. 2.3.2 Study design The study design was established according to available information on the test substance and the OECD (No. 404) and EC (92/69/EEC, B.4) guidelines. As possible irritant effects were anticipated, the test substance was evaluated on a single animal (No. 899) in the first instance. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank. Since the test substance was not severely irritant on this first animal, it was then applied for 4 hours to two other animals (Nos. 45 and 46). 2.3.3 Application of the test substance Doses of 0.5 ml of the undiluted test substance were placed on a dry gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals. The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. The untreated skin served as control. . No residual test substance was observed on removal of the dressing. 2.3.4 Chronology of the study Animal number 899 45 46 Date of treatment (day 1) 6 July 1999 (application for 3 minutes and 4 hours) 8 July 1999 ' 8 July 1999 End of the observation period 10 July 1999 12 July 1999 13 July 1999" 2.4 CUTANEOUS EXAMINATIONS . The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. Following the OECD and EC guidelines: . when there was no evidence of dermal irritation after 72 hours, the study was ended. . when there was persistent cutaneous irritation after 72 hours, the observation period was extended to a maximum of 14 days (until day 15) in order to determine the progress of the lesions and their reversibility. . when severe irritant effects were observed, the animals were killed on humane grounds. Any change in the animals'behaviour was noted. Company Salutinoci. Do s t contain TSC CB CIT/StudyNo. 18746 T 13 2.5 DESCRIPTION AND EVALUATION OF CUTANEOUS REACTIOxNS Dermal irritation was evaluated for each animal according to the following scoring scale: Erythema and eschar formation: . no erythema............................................................................................................. . very slight erythema (barely perceptible)............................................................... . well-defined erythema............................................................................................ . moderate to severe erythema.................................................................................. . severe erythema (beet redness) to slight eschar formation (injuries in depth)..... 0 1 2 3 4 Oedema formation . no oedema................................................................................................................ . very slight oedema (barely perceptible)................ ................................................. . slight oedema (edges of area well-defined by definite raising)............................. . moderate oedema (raised approximately 1 millimetre)......................................... . severe oedema (raised more than 1 millimetre and extending beyond area of exposure)............................................................................................................. 0 1 2 3 4 Any other lesions were noted. 2.6 INTERPRETATION OF RESULTS AND CLASSIFICATION OF SUBSTANCES The results obtained were evaluated in conjunction with the nature and the reversibility of the findings observed. Classification of the test substance is based on the criteria laid down in Commission Directive 93/21/EEC of 27 April 1993 adapting to technical progress for the eighteenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. 2.6.1 Interpretation of the results 2.6.1.1 Criteria for irritation A substance or a preparation is considered to be irritating to the skin if, when it is applied to healthy intact animal skin for up to 4 hours, significant inflammation is caused and which persists for 24 hours or more after the end of the exposure period. 2.6.1.2 Criteria for corrosion A substance or a preparation is considered to be corrosive if, when it is applied to healthy intact animal skin, it produces full thickness destruction of skin tissue on at least one animal during the test for skin irritation, or if the result can be predicted, for example: from strongly acid or alkaline reactions. ompany Sami' :2d. Does not c intain TSCA CBl CIT/Study No. 18746 T. f] 14 2.6.2 Qassification of the test substances 2.6.2.1 Irritant substances - symbol Xi, indication of danger "irritant", - phrases indicating the nature of special risks: R 38: "Irritating to skin" Inflammation is significant if: . the mean value of the scores is two or more for either erythema and eschar formation or oedema formation. The same will be the case where the test has been completed using three animals if the score for either erythema and eschar formation or oedema formation observed in two or more animals is equivalent to the value of two or more, . it persists in at least two animals at the end of the observation period. Specific effects such as hyperplasia, desquamation, discolouration, fissures, eschar and alopecia should be taken into account. All scores obtained at each reading time (24, 48 and 72 hours) for an effect are used for calculating the respective mean values. 2.6.2.2 Corrosive substances - symbol C, indication of danger "corrosive", - phrases indicating the nature of special risks: . R 34: "Causes bums" If, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a result of up to 4 hours exposure, or if this result can be predicted. . R 35: "Causes severe bums" If, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a result of up to 3 minutes exposure, or if this result can be predicted. 2.7 PROTOCOL ADHERENCE The study was performed in accordance with Study Protocol No. 18746 TAL and subsequent . amendments, with the following deviations from the agreed Study Protocol: . the temperature and relative humidity recorded in the animal room were sometimes outside of the target ranges specified in the protocol. . These minor deviations were not considered to compromise the validity or integrity of the study. Company not contain TSCA CBi CIT/StudyNo. 18746T 15 2.8 ARCHIVING The study documentation and specimens generated during the course of the study are archived at CIT, 27005 Evreux, France, for 10 years after the end of the in vivo phase of the study. The archived study materials include: . protocol and possible amendments, . raw data, . correspondence, . final report and possible amendments. On completion of this period, the archived study materials will be returned to the Sponsor, or may be archived at CIT for a further period. In addition, raw data not specific to the study including, but not limited to, certificates of analyses for food, water and bedding (if applicable) and records of environmental data and equipment calibration, are also archived at CIT and retained for at least 30 years. IT/Study No. 18746 T 16 3. RESULTS The observations recorded during the study are presented in tables 1 and 2. After a 3-minute exposure (one animal): No cutaneous reactions were observed. After a 4-hour exposure (three animals): A very slight erythema (grade 1) was noted in all animals from day 1 or 2 (one animal) to day 4. Dryness of the skin was recorded in one animal on days 4 and 5. No other cutaneous reactions were observed during the study. Mean scores over 24, 48 and 72 hours for each animal were 1.0, 1.0 and 1.0 for erythema and 0.0,0.0 and 0.0 for oedema. 4. CONCLUSION Under our experimental conditions, the test substanc slightly irritant when applied topically to rabbits. . is According to the classification criteria laid down in Commission Directive 93/21/EEC (27th April 1993) adapting to technical progress for the eighteenth time Council Directive 67/548/EEC, the test substance was considered non-irritant. Com ply i not contaiinnTSCACBt CIT/Study No. 18746 T 17 Table 1: Individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for the first animal (application for 3 minutes) Rabbit number Dermal Irritation lh D1 899 Erythema 0 Oedema Other 0 * (1) mean of scores on days 2, 3 and 4 h - hour D -day (+) - irritant according to E.E.C. criteria (-) - non-irritant according to E.E.C. criteria * - None Scores 24h 48h D2 D3 Mean Interpretation irritation (+) 72h score(1) D4 (-) 000 000 *** 0.0 0.0 (-) (-) - - o b t a i n TSCftCaV Company Santtt ;cd.0025 CIT/Study No. 18746 TAi a 18 Table 2: Individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal (application for 4 hours) Rabbit number Dermal Irritation Scores lh 24h 48h 72h D1 D2 D3 D4 D5 D6 Mean irritation score (1) Interpretation (+) (-) 899 Erythema 0 1 1 10 - 1.0 (-) Oedema Other 00 0 0 0 - ***** - 0.0 (-) 45 Erythema 1 1 1 10 - 1.0 (-) Oedema Other 00 0 00 * * ** - 0.0 (-) 46 Erythema 11I I00 1.0 (-) Oedema 00 0 00 0 0.0 (-) . Other- ** *ss * (1) mean of scores on days 2,3 and 4 h - hour D -day (+) - irritant according to E.E.C. criteria (-) - non-irritant according to E.E.C. criteria * - None S - Dryness of the skin - - Cutaneous examination not performed company- J i Q'jS contain __ -- APPENDICES nolconla;n t s c a cbi ; C .2 - 23 Compan S8t`' CIT/Study No. 18746 T. 20 1. Test article description and analytical certificate C crflpaW j^'-" '-- CIT/Study No. 18746 T i TOXICOLOGY DEPARTMENT CONFIDENTIAL April 99 elf atochem s.a. La dfense 10, cours Michelet 92091 Paris-la-Dfense, France TESTARTICLE DESCRIPTION 21 IDENTITY PHYSICAL AND CHEMICAL PROPERTIES Appearance Melting point Flash point Solubility TOXICOLOGICAL INFORMATIONS AND USE SAFETY See safety data sheet__________________________________ STORAGE AND DISPOSAL Storage Expiry date Disposal : in dark and at room temperature : may 2000 ' : incineration Copsny Sani= '.Ocontain TSCACBl CIT/StudyNo. 18746 T elF atochem Sj Eli Atochem S.A. Iteino de VlflervSaJ(-PBtJ ZA Vlors Saint Paul - Pieux B-P. 20 - 50670 Ricux (Fiance) Tl : *4.74.44.74 - Fax : <<.74.-t2.07 - T* : u o <29 ATO VSP 22 ViUcr SeinC P aul, le 9 N o v em b re t W CERTIFICAT D'ANALYSE Loi N* Extrait Scc Point clair pH Taille des Particules Test d'application Cuir olophobie et hydrophobie Unit Rsultat Spcification Mthode de d'analyse fabrication % LCU 622 1C LCU 057 LCU 642 iw*rr [Wjrnn LCU 672 1W fl F J LCU 674 Le Chef de Service du Laboratoire SIGNATURE: fSC A c % ,Q\CO & *n CIT/StudyNo. 18746 T. \ if* 23 Diet formula s3 not contain t s c a cb\ ompan Sani>ize!i-oc CIT/Study No. 18746 T 24 Ref: 112 COMPLETE DIET RABBIT MAINTENANCE DIET Appearance: 4.5 mm diameter granules Conditioning: bags of 25 kgs Daily portion: in accordance with race and body weight, Rabbits 100-150 g, water ad libitum. FORMULA % MINERALS (calculated in mg/kg) Nat. CMV Cereals...................................... 43.8 val. val. Total Grain byproducts and legumes. 49 P..................... .. 3500 3500 7000 Vegetable protein (soya bean Ca ................. 4500 4500 9000 meal, y east).............................. 4.2 K ................... 11600 0 11600 Vitamin and mineral mixture.... 3 N a ................. 400 1600 2000 M g................. 2100 100 2200 AVERAGE ANALYSIS % M n ................ 40 40 80 Fe................... 160 140 300 Calorific value (Kcal/kg)......... 2200 Cu ................. 12 15 27 Moisture..................................... 10 Zn ............. . 30 45 75 Proteins..................................... 13 C o ................ 0.1 1.5 1.6 Lipids......................................... 2.7 I ..................... 0 0 0 Carbohydrates (N.F.E.) 49.3 C l .............. . 500 3000 3500 Fibre........................................... 17 Minerals (ash)........................... 8 AMINO ACID VALUES (calculated in mg/kg) Arginine..................................... Cystine....................................... Lysine....................................... Methionine................................ Tryptophan................................ Glycine...................................... FATTY ACID VALUES (calculated in mg/kg) Palmitic acid............................. Palmitoleic acid........................ Stearic acid................................ Oleic acid.................................. VITAMINS (calculated per kg) Nat. CMV val. val. Total Vitamin A 2850IU 6500IU 9350 IU 6800 Vitamin D3 3 0 IU 1000IU 1030 IU 2100 Vitamin B 1 4.3 mg 0 mg 4.3 mg 4600 Vitamin B2 3.8 mg 0 mg 3.8 mg 1600 Vitamin B3 16 mg 0 mg 16 mg 1400 Vitamin B6 1 mg 1 mg 2 mg 5200 Vitamin B12 0 mg 0 mg 0 mg Vitamin E 16 mg 10 mg 26 mg Vitamin K3 6 mg 1 mg 7 mg - Vitamin PP 55 mg 5 mg 60 mg. Folic acid 0 mg 0 mg 0 mg 6400 Biotin 0 mg 0 mg 0 mg 0 Choline 850 mg 200 mg 1050 mg 600 vleso-Inositol 0 mg 0 mg 0 mg 6400 Linoieic acid... Linolenic acid. 12100 2400 Available under quality "Control Ref.: 112 C" UAR, 7 rue Gallini, 91360 Villemoisson - Tel : 01.69.04.03.57 - Fax : 01.69.04.81.97 (Ref. Doc. UAR: 1992) noos not contain TSCAC^ Company Samtizs- ;