Document B8Dx9nVK18QKnKbpyw7y7rekL
%
AR226-3067
SPONSOR ElfAtochemS.A. Cours Michelet
La Defense 10
92091 Paris-la-Defense CEDEX
France
STUDY TITLE ACUTE EYE IRRITATION
IN RABBITS TEST SUBS
STUDY DIRECTOR
Stephane de Jouffrey
STUDY COMPLETION DATE
28 January 1997
PERFORMING LABORATORY Centre International de Toxicologie (C.I.T.)
Miserey - 27005 Evreux - France
LABORATORY STUDY NUMBER 14888 TAL
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CONTENTS
STATEMENT OF THE STUDY DIRECTOR OTHER SCIENTISTS INVOLVED IN THIS STUDY STATEMENT OF QUALITY ASSURANCE UNIT SUMMARY RESUME
1. INTRODUCTION
8
2. MATERIALS AND METHODS
8
2.1. TEST SUBSTANCE
8
2.1.1 Identification
8
2.1.2 Preparation
'
8
2.2. TEST SYSTEM
9
2.2.1 Animals
9
2.2.2 Environmental conditions
9
2.2.3 Food and water
9
2.3. TREATMENT
10
2.3.1 Selection of the animals
10
2.3.2 Study design
10
2.3.3 Administration of the test substance
10
2.3.4 Date of treatment
10
2.4. OCULAR EXAMINATIONS
10
2.5. DESCRIPTION AND EVALUATION OF OCULAR REACTIONS
11
2.5.1 Conjunctiva! lesions and discharge
11
2.5.2 Iris lesions
11
2.5.3 Comeal lesions
11
_
2.6. INTERPRETATION OF RESULTS AND CLASSIFICATION OF SUBSTANCES 12
2.6.1 Interpretation of the results
12
2.6.2 Classification of the test substances
12
'
2.7. ARCHIVES
13
3. RESULTS (table 1)
14
4. CONCLUSION
14
Table 1: Individual ocular examinations and mean values'ofthe scores recorded
at each reading (24,48 and 72 hours) for each animal
15
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APPENDICES
1. Test article description 2. Diet formula
16
17
19 and 20
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TSCA
CBI
STATEMENT OF THE STUDY DIRECTOR
The study was performed in compliance with the following Principles of Good Laboratory Practice Regulations: . O.E.C.D. Principles of Good Laboratory Practice, Decision Concerning Mutual Acceptance of
Data in the Assessment of Chemicals, C(81)30(final) Annex 2. May 12, 1981. . Decret N 90-206 du 7 mars 1990 concemant les Bonnes Pratiques de Laboratoire (Journal
Officiel du 9 mars 1990), Ministere de 1'Industrie et de I'Amenagement du Territoire.
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 the Centre International de Toxicologie (C.I.T.), Miserey, 27005 Evreux, France.
Toxicology
-t
'S. de^iffrd
Study Director Doctor of Veterinary Medicine
Head of Short-term and Environmental
Toxicology
OTHER SCIENTISTS INVOLVED IN THIS STUDY
For Pharmacy: J. Richard
Doctor of Pharmacy
For Toxicology: C. Pelcot Study Supervisor
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STATEMENT OF QUALITY ASSURANCE UNIT
1. Specific study inspections
Type of inspections
Inspections
Protocol Report
21 Oct. 96 20 Jan. 97
Dates
Report to
Study Director (*)
29 Oct. 96 21 Jan. 97
Report to Management (*)
29 Oct. 96 21 Jan. 97
2. Routine inspections performed on other studies of the same type according to a frequency defined in Q.A.U. procedures
Inspected phase
Inspections
Dates
Report toReport to
Study Director (*)
Management (*)
Treatment/test substance Preparation/test substance
20 Aug. 96 25 Sept. 96
23 Aug. 96 25 Sept. 96
23 Aug. 96 25 Sept. 96
The inspections were performed in compliance with C.I.T. Quality Assurance Unit procedures and the Good Laboratory Practice Regulations.
(*) The dates mentioned correspond to the dates of signature of audit reports by Study Director
and Management.
D.u^Tai)V? ^
L. Valette-TaIbi Date: 28 January Doctor of Biochemistry Head of Quality Assurance Unit and Scientific Archives
1997
^ompan'y' Sanftfzed.
'^con^rso^
SUMMARY
^lf^HBBBHHH--------1 At the request of Elf Atochem S.A., Paris-la-Defense, France, the potential of the test substance to induce ocular irritation was evaluated in rabbits
according to O.E.C.D. (No. 405, 24th February 1987) and E.C. (92/69/E.E.C., B,, 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.
As no irritant effects were anticipated, a single dose of 0.1 ml of the test substance was instilled into the left conjunctival sac of three male New Zealand White rabbits. The right eye served as
control.
The test substance was used in its original form.
The eyes were not rinsed after administration of the test substance.
Ocular reactions were observed approximately one hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions.
The mean values of the scores recorded for each animal after 24, 48 and 72 hours were
calculated.
Results
Very slight to moderate conjunctival reactions were noted in all animals: very slight to moderate chemosis, very slight to moderate conjunctival redness and clear to whitish purulent discharge were observed from day 1 up to day 4 (one animal) or 6 (two animals). Slight iritis was observed on day 2 in two animals; it persisted for 24 hours in one of them. Very slight corneal opacity was also noted in all animals on day 2; it persisted up to day 4.
Reversibility of ocular lesions was noted on day 5-(one animal) or 7.
The mean scores calculated for each animal over 24, 48 and 72 hours were 1.3, 2.0 and 2.0 for chemosis, 2.0, 2.3 and 2.3 for redness of the conjunctiva, 0.7, 0.0 and 0.3 for iris lesions and 1.0, 1.0 and 1.0 for corneal opacity.
Conclusion
Under our considered
experimental irritant when
I___ conditions, the test substance
administered by ocular route in rabbits.
was
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RESUME
flUBRHBUBBR A la demande de Elf Atochem S.A., Paris-la-Defense, France, 1'imtation oculaire pouvant etre
induite par Ie produit,
a ete evaluee chez Ie Lapin conformement
aux lignes directrices de 1'O.C.D.E. (No. 405, 24th February 1987) et de la C.E.E.
(92/69/E.E.C., Bs, 31st July 1992). L'etude a ete realisee conformement aux regles de Bonnes
Pratiques de Laboratoire.
Methodes
L'etude a ete realisee selon les informations disponibles sur Ie produit et les lignes directrices mentionnees ci-dessus.
Aucun effet irritant n'etant suppose, une dose unique de 0,1 ml de produit a ete instillee dans Ie cul de sac conjonctival de 1'oeil gauche de 3 lapins males New Zealand White. L'oeil droit a servi de temoin.
Le produit a ete utilise tel quel.
Aucun ringage des yeux n'a ete realise apres 1'administration du produit.
Les reactions oculaires ont ete observees environ 1 heure, 24, 48 et 72 heures apres 1'administration puis quotidiennementjusqu'a la reversibilite des lesions.
La moyenne des scores enregistres apres 24, 48 et 72 heures a ete calculee pour chaque animal.
Resultats
Des reactions conjonctivales tres legeres a moderees sont observees chez tous les animaux : un chemosis tres leger a modere, une rougeur de la conjonctive tres legere a moderee, et un larmoiement clair (ou purulent blanchatre chez 1 animal) sont notes du jour 1 jusqu'au jour 4 (1 animal) ou 6 (2 animaux). Un leger iritis est observe chez 2 animaux au jour 2 ; il persiste pendant 24 heures chez 1'un d'entre eux. Une opacite corneenne tres legere esc egalement notee chez tous les animaux au jour 2 ; elle
persiste j usqu' au jour 4,
La reversibilite des lesions oculaires est observee aujour 5 (1 animal) ou 7.
Les scores moyens individuels calcules apres 24, 48 et'72 heures sont de 1,3 ; 2,0 et 2,0 pour le chemosis, 2,0 ; 2,3 et 2,3 pour la rougeur de la conjonctive, 0,7 ; 0,0 et 0,3 pour 1'iritis et 1,0 ; 1,0 et 1,0 pour 1'opacite corneenne.
Conclusion
Dans nos conditions experimentales, le produit irritant par voie oculaire chez le Lapin.
est considere
^^--------------^o,
1. INTRODUCTION
The objective of this study was to evaluate the potential of the test substance
to induce ocular irritation following a single administration in rabbits.
In the assessment of the toxic characteristics of a test substance, determination of the irritant effects on the eyes of mammals is an important initial step.
Information derived from this test serves to indicate the possible existence of hazards to Man likely to arise from exposure of the eyes, and associated mucous membranes, to the test
substance.
This study was conducted in compliance with; . O.E.C.D. guideline No. 405,24th February 1987.
. E.C. Directive No. 92/69/E.E.C, By 31st July 1992.
2. MATERIALS AND METHODS
2.1. TEST SUBSTANCE
^U^B^Bf 2.1.1 Identification_____
The test substance
used in the study was supplied by ElfAtochem S.A.
Documentation supplied by the Sponsor identified the test substance as follows:
. name:
. ^^^^^^^^^^
. batch number:
^^^^^
^^HHw . Elf Atochem filing number:
. description: dark brown liquid
, container: one plastic flask . date of receipt: 11 October 1996
. storage conditions: at room temperature and protected from light.
Data relating to the characterization of the test substance are documented in a test article description (presented in appendix 1) provided by the Sponsor. At the beginning of the study, the analytical certificate was not available.
The pH of the test substance as mentioned in the safety data sheet was 8.5.
2.1.2 Preparation The test substance was used in its original form.
cm"u"sanlt^eao^^^^
2:2. TEST SYSTEM
2.2.1 Animals Sex, species, strain: male New Zealand White rabbits. Reason for this choice: species commonly requested by the international regulations for this type of study. Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France. Number of animals and identification: three animals were used, as recommended by the international regulations and taking into account that a good correlation of results can be obtained with either three or six animals (i). The animals were identified individually with a metal tag in the ear.
Weight: on the day of treatment, the animals had a mean body weight standard deviation of 2.4 0.2 kg. Acclimatization: at least five days before the beginning of the study.
2.2.2 Environmental conditions During the acclimatization period and during the main test, the environmental conditions in the animal room were set as follows:
. temperature: 183C
. 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 recorded continuously and records retained. The housing conditions (temperature, relative humidity and ventilation) were checked monthly. The animals were housed individually in polystyrene cages (35 cm x 55 cm x 32 cm or 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 All the animals had free access to 112 C pelleted diet (U.A.R.., 91360 Villemoisson-sur-Orge, France). Each batch of food was analysed (composition and contaminants) by the supplier. The diet formula is presented in appendix 2.
Drinking water filtered by a F.G. Millipore membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analysis of the water and diet and detection of possible contaminants (pesticides, heavy metals and nitrosamines) are performed periodically. Results are archived at C.I.T.
It was verified that no contaminants in the diet or water at levels likely to influence the outcome of the study were present.
(1) Talsma, D.M.; Leach, C.L.; Hatoum, N.S.; Gibbons, R.D.; Roger, J.C.; Garvin, J.P.: Reducing the number of rabbits in the Draize eye irritancy test: A statistical analysis of 155 studies conducted over 6 years. Fundamental and Applied Toxicology. 10: 1, 146-153 (1988).
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2.3. TREATMENT
2.3.1 Selection of the animals The day before treatment, the eyes of each animal were examined in order to use only animals without any signs of ocular irritation. Animals showing signs of ocular irritation, ocular defects or pre-existing comeal injury were not used.
2.3.2 Study design The study design was established according to available information on the test substance and according to the O.E.C.D. and E.C. guidelines.
As no irritant effects were anticipated, the test substance was evaluated in three animals.
2.3.3 Administration of the test substance The test substance was used in its original form.
A single dose of 0.1 ml of the test substance was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
The lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye, which remained untreated, served as a control,
The eyes were not rinsed after administration of the test substance.
2.3.4 Date of treatment
Animal number 01 02 03
Date of treatment (day 1) 12 November 1996 12 November 1996 12 November 1996
End of the observation period 16 November 1996 18 November 1996 18 November 1996
2.4. OCULAR EXAMINATIONS
The eyes were examined approximately one hour, 24, 48 and 72 hours after administration of
the test substance.
Following the O.E.C.D. and E.C. guidelines: . when there is no evidence of irritation after 72 hours, the study is ended. . when there is persistent ocular irritation after 72 hours, the observation period is extended to a
maximum of 21 days (until day 22) in order to determine the progress of the lesions and their reversibility. . when severe irritant effects are observed, the animals are killed on humane ground.
Any change in the animals' behaviour was noted.
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|
I
^^
^y
2.5. DESCRIPTION AND EVALUATION OF OCULAR REACTIONS
Ocular reactions were evaluated for each animal according to the following numerical scale;
2.5.1 Conjunctival lesions and discharge Chemosis (lids and/or nictitating membranes) . no swelling ............................................................................................................... 0 . any swelling above normal (includes nictitating membranes) ................................. 1 . obvious swelling with partial eversion of lids ......................................................... 2*
. swelling with lids about half-closed ......................................................................... 3* . swelling with lids more than half-closed ................................................................. 4*
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris) . blood vessels normal ............................................................................................... 0 . a number of blood vessels definitely hyperaemic (injected) .................................... 1 . diffuse, crimson colour, individual vessels not easily discernible .......................... 2*
, diffuse, beefy red ...................................................................................................... 3*
Discharge . absence of discharge ................................................................................................. 0 . slight discharge (does not include small amounts normally found
in inner canthus) ....................................................................................................... 1 . discharge with moistening of lids and hairs adjacent to lids .................................... 2 . discharge with moistening of lids and hairs on wide area around the eye ............... 3
2.5.2 Iris lesions 0
. normal....................................................................................................................... . markedly deepened rugae, congestion, swelling, moderate circum-corneal hyper-
aemia, or injection, any of these or combination of any thereof, iris still reacting
to light (sluggish reaction is positive) ...................................................................... I*
. no reaction to light, haemorrhage, gross destruction (any or all of these) ............... 2*
2.5.3 Corneal lesions
Cornea (direct examination or, if necessary, with an Ultra-Violet lamp) To determine the presence or absence ofcomeal opacification and to evaluate the affected area, one or two drops of 0.5% sodium fluorescein solution can be instilled into the eye (however,
this must be performed before the 24-hour reading).
If corneal opacification is difficult to determine, the eye can be examined under a U.V. lamp (a clear fluorescence is visible in the areas of opacification).
Opacity (degree of intensity: area most dense taken for reading) . no ulceration or opacity ............................................................................................ 0 . scattered or diffuse areas of opacity (other than slight dulling or normal lustre),
details of iris clearly visible ................................................................................... I* . easily discernible translucent area, details of iris slightly obscured ........................ 2* . nacrous areas, no details of iris visible, size of pupil barely discernible ................. 3*
. opaque cornea, iris not discernible through the opacity .......................................... 4*
* indicates positive effect
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Area of opacity . one quarter (or less) but not zero ............................................................................ 1 . greater than one quarter but less than a half ........................................................... 2 . greater than one half but less than three quarters .................................................. 3 . greater than three quarters up to whole area .......................................................... 4
Any other lesions observed 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 scores observed, whilst taking into account all the reactions of the treated animals.
2.6.1 Interpretation of the results
Criteria for irritation A substance or a preparation is considered irritant for the eyes if, when applied to the eye of the animal, significant severe ocular lesions are caused within 72 hours after exposure and which persist for 24 hours or more after treatment with the test substance. All the scores at each reading time (24, 48 and 72 hours) and for an effect are used by calculating the respective mean values.
2.6.2 Classification of the test substances - Xi symbol, indication of danger "irritant",
- phrases indicating the nature of special risks:
R 36: "Irritating to eyes"
Ocular lesions are significant if the mean score has any of the following values: . opacity of the cornea > 2, but < 3, . lesion of the iris >. 1, but ^ 1.5, . redness of the conjunctivae S 2.5, . oedema of the conjunctivae (chemosis) > 2.
Or else, if the test is performed on three animals, if at least two of them show lesions equal to one of the following values: . opacity of the cornea > 2, but < 3, . lesion of the iris > 1, but $ 2, . redness of the conjunctivae >. 2.5, . oedema of the conjunctivae (chemosis) >. 2.
R 41: "Risk of serious damage to eyes"
Ocular lesions are severe: if the mean score has any of the following . opacity of the cornea > 3, . lesion of the iris > 1.5.
values:
Or else, if the test is performed on three animals, if at least two of them show lesions equal to one of the following values: . opacity of the cornea > 3, . lesion of the iris = 2.
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Or if they persist at the end of the observation period. If the test substance or preparation induces irreversible colouration of the eyes, the
phrase R 41 should also be applied.
2.7. ARCHIVES
The study documentation and materials, namely: . protocol and possible amendments, . raw data, . correspondence, . final report and possible amendments, are stored in the archives of C.I.T., Miserey, 27005 Evreux, France, for five years after the end of the in vivo phase of the study. At the end of this period, the study documentation will be returned to the Sponsor.
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3. RESULTS (table 1)
Very slight to moderate conjunctival reactions were noted in all animals: very slight to moderate chemosis (grades 1 to 3), very slight to moderate conjunctival redness (grades 1 to 3) and clear to whitish purulent discharge were observed from day 1 up to day 4 (1 animal) or 6 (two animals). Slight iritis (grade 1) was observed on day 2 in two animals; it persisted for 24 hours in one of them. Very slight comeal opacity (grade 1) was also noted in all animals on day 2; it persisted up to day 4.
Reversibility of ocular lesions was noted on day 5 (one animal) or 7.
The mean scores calculated for each animal over 24, 48 and 72 hours were 1.3, 2.0 and 2.0 for chemosis, 2,0, 2.3 and 2.3 for redness of the conjunctiva, 0.7, 0.0 and 0.3 for iris lesions and 1.0, 1.0 and 1.0 for comeal opacity.
4. CONCLUSION
Under our experimental conditions, the test substance I
was
considered irritant when administered by ocular route in rabbits.
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Table 1: Individual ocular examinations and mean values ofihe scores recorded at each reading (24,48 and 72 hours) for each animal
RalAit nurober
Region of eye
01
Conjunctivae
Descripriori
Scon;S
of ocular
reactions
Ih 24h 48h 72h
Dl D2 D3 D4 D5 D6 D7
Chemosis
2
2
1
1
0
Redness
1
3
2
1
0
Mean irritation score (1)
1,3 2,0
Interpretation (+) (-)
(-) (-)
Discharge
E
2
0
0
0
0,7
Iris
0
1
1
0
0
0,7
(-)
Comeal opacity
Intensity Area
0
1
1
1
0
0
3
2
1
0
1,0
(-)
2,0
02""
Other Fluorescein Conjunctivae
Chemosis Redness
*
*
*
*
*
/
U
U
"""3""" ,.....3y"..".". '"""2"" .".....iH"... " i
2
3
2
2
i
-
-
"""i"""" ""6"""" ""'""2,0"""
i
0
2,3
""""""""C+T""""" (-)
Discharge
E
S
S
0
0
0
0
(2)
Iris
0
0
0
0
0
0
0
0,0
(-)
Corneal opacity
Intensity
0
1
1
i
0
0
0
1,0
(-)
Area
0
3
2
i
0
0
0
2,0
Other
*
4)
*
*
+
4
*
Fluorescein
1
U
U
U
U
1
i
03"
Conjunctivae
Chemosis
3
3
2
1
1
1
0
2,0
(+)
Redness
2
3
2
2
1
1
0
2,3
(-)
Discharge
E
2
0
0
0
0
0
0.7
Iris
0
1
0
0
0
0
0
0,3
(-)
Comeal opacity
Intensity
0
1
1
1
0
0
0
1,0
(-)
Area
0
3
2
1
0
0
0
2,0
'
Other
Fluorescein
*
*
*
*
4
*
*
/
U
U
U
U
/
/
(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
(2; = not calculated U = Fluorescein batch No. 5253 / ' = Fluorescein not used
^E = Scoring obscured by residual test substance
> = Whitish purulent discharge = Ocular examination not performed
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APPENDICES Company Sanitized. Does not contain TSCA CB&
17 1. Test article description
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TOXICOLOGY DEPARTMENT
CONFIDENTIAL
10 October 1996
elf atochem s.a.
La defense 10, cedex42
92091 Paris-la-Defense, France
TEST ARTICLE DESCRIPTION
IDENTITY
Test article name Chemical name
CAS number EINECS number Purity Origin and batch Batch Elf Atochem filing number
PHYSICAL AND CHEMICAL PROPERTIES
Appearance Melting point Boiling point Flash point Solubility
brownish liquid -22C 95C 50C
water
TOXICOLOGICAL INFORMATIONS AND USE SAFETY
See safety data sheet
__
STORAGE AND DISPOSAL
Storage Expiry date
Disposal_____________
in dark and ai room temperature December 1997
incineration
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2. Diet formula
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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.
t-UKMULA %
Cereals .................................... Grain biproducts and legumes
................................... Vegetable proteins (soya bean meal, yeast) ............................ Vitamin and mineral mixture ...
AVERAGE ANALYSIS %
43.8 49
4.2 3
Calorific value (KCal/kg)........ Moisture ................................. Proteins ................................... Lipids
..................................... Carbohydrates (N.F.E.) .......... Fibre
....................................... Minerals (ash)
........................
AMINO ACID VALUES
(calculated in mg/kg)
2200
10 13
2.7 49.3
17 8
Arginine
....
Cystine ......
Lysine
.......
Methionine Tryptophan Glycine
.....
FATTY ACID VALUES
(calculated in mg/kg)
6800 2100 4600 1600 1400 5200
Palmitic acid...... Palmitoleic acid.,
Stearic acid......... Oleic acid........... Linoleic acid...... Linolenic acid....
6400 0
600 6400 12100 2400
MINERALS (c alculated nmg/kg)
Nat.
CMV
val.
val.
Total
P.......... ....
Ca
....
K
......... ....
Na .......
Mg ...... ....
Mn ......
FP
Cu ....... Zn ....... Co ....... I
..........
3500 4500 11600
400 2100
40 160
12 30
0.1' 0 snn
3500 4500
0 1600
100 40 140 15 45
1.5 0
3000
7000 9000 11600 2000 2200
80 300
27 75
1.6 0
3500
vnFAMINS (c;alculated perkg)
Nat.
CMV
val.
val.
Total
Vitamin A Vitamin D3 Vitamin B 1 Vitamin B2 Vitamin B3 Vitamin B6 Vitamin B 12 Vitamin E Vitamin K3 Vitamin PP Folic acid '
Biotin
Choline
Meso-Inositol
2850 IU 30 IU
4.3 mg
3.8 mg 16 mg
1 mg
Omg 16 mg 6mg 55 mg Omg
Omg 850 mg
Omg
6500 IU 1000 IU
Omg Omg Omg 1 mg Omg 10 mg
1 mg
5mg Omg Omg 200 mg
Omg
9350IU 1030 IU
4.3 mg
3.8 mg 16 mg
2mg Omg 26 mg 7mg 60 mg
Omg
Omg 1050 mg
Omg
Available under quality "Control Ref.: 112 C"
U.A.R., 7 rue Gallieni, 91360 Villemoisson - Tel: 69.04.03.57 - Fax : 69.04.81.97 (Ref. Doc. UAR: 1992)
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