Document qaBrXD12vVQ1jDb4nzOKp8ndR
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SPONSOR Elf Atochem S.A. Cours Michelet La Dfense 10 92091 Paris-la-Dfense CEDEX
France
STUDY TITLE ACUTE EYE IRRITATION
IN RABBITS
AR226-3067
STUDY DIRECTOR Stphane de Jouffrey
STUDY COMPLETION DA TE 28 January 1997
PERFORMING LABORATORY Centre International de Toxicologie (C.I.T.)
Miserey - 27005 Evreux - France
LABORATORY STUDY NUMBER 14888 TAL
. Com pany Sanitized. D oes not contain T S C A C B !
CONTENTS
STATEMENT OF THE STUDY DIRECTOR
4
OTHER SCIENTISTS INVOLVED IN THIS STUDY
4
STATEMENT OF QUALITY ASSURANCE UNIT SUMMARY
5 6
RESUME
7
1. INTRODUCTION
g
2. MATERIALS AND METHODS
2.1. TEST SUBSTANCE 2.1.1 Identification 2.1.2 Preparation
'
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 Selection of the animals 2.3.2 Study design 2.3.3 Administration of the test substance 2.3.4 Date of treatment
2.4. OCULAR EXAMINATIONS
2.5. DESCRIPTION AND EVALUATION OF OCULAR REACTIONS 2.5.1 Conjunctival lesions and discharge 2.5.2 Iris lesions 2.5.3 Comeal lesions
2.6. INTERPRETATION OF RESULTS AND CLASSIFICATION OF SUBSTANCES 2.6.1 Interpretation of the results
2.6.2 Classification of the test substances
2.7. ARCHIVES
`
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9 9 9 9 10 10 10 10 10
10
11 11 1j 1j
12 12 12 13
3. RESULTS (table 1)
14
4. CONCLUSION
14
Table 1: Individual ocular examinations and mean values'of the scores recorded at each reading (24, 48 and 72 hours) for each animal
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APPENDICES
1. Test article description 2. Diet formula
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17 19 and 20
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4
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.
. 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.
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
Date: 28 January 1997
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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5
STATEMENT OF QUALITY ASSURANT. 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
Treatment/test substance 20 Aug. 96 Preparation/test substance 25 Sept. 96
Dates
Report toReport to
Study Director (*)
Management (*)
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.
aWf - 1al)V>?
L. Valette-Talbi Date: 28 January 1997 Doctor of Biochemistry Head of Quality Assurance Unit and Scientific Archives
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SUMMARY
A n h ^ eq u e s^ fE l^ to c h em S A ^ P aris-la -D fen se, 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., B5, 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 experimental conditions, the test substance! considered irritant when administered by ocular route in rabbits.
was
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RESUME
A la demande de Elf Atochem S.A., Paris-la-Dfense, France, l'irritation oculaire pouvant tre
induite par le produit,
a ^va^u^e chez Lapin conformment
aux lignes directrices de l'O.C.D.E. (No. 405, 24th February 1987) et de la C.E.E.
(92/69/E.E.C., Bs, 3 lst July 1992). L'tude a t ralise conformment aux rgles de Bonnes
Pratiques de Laboratoire.
Mthodes
L'tude a t ralise selon les informations disponibles sur le produit et les lignes directrices mentionnes ci-dessus.
Aucun effet irritant n'tant suppos, une dose unique de 0,1 ml de produit t instille dans le cul de sac conjonctival de l'oeil gauche de 3 lapins mles New Zealand White. L'oeil droit a servi de tmoin.
Le produit a t utilis tel quel.
Aucun rinage des yeux n'a t ralis aprs l'administration du produit.
Les ractions oculaires ont t observes environ 1 heure, 24, 48 et 72 heures aprs l'administration puis quotidiennement jusqu' la rversibilit des lsions.
La moyenne des scores enregistrs aprs 24, 48 et 72 heures a t calcule pour chaque animal.
Rsultats
Des ractions conjonctivales trs lgres modres sont observes chez tous les animaux : un
chmosis trs lger modr, une rougeur de la conjonctive trs lgre modre, et un
larmoiement clair (ou purulent blanchtre chez 1 animal) sont nots du jour 1 jusqu'au jour 4
(1 animal) ou 6 (2 animaux).
Un lger iritis est observ chez 2 animaux au jour 2 ; il persiste pendant 24 heures chez l'un
d'entre eux.
Une opacit cornenne trs lgre est galement note chez tous les animaux au jour 2 ; elle
persiste jusqu'au jour 4-
-
La rversibilit des lsions oculaires est observe au jour 5 (1 animal) ou 7.
Les scores moyens individuels calculs aprs 24, 48 et'72 heures sont de 1,3 ; 2,0 et 2,0 pour le chmosis, 2,0 ; 2,3 et 2,3 pour la rougeur de la conjonctive, 0,7 ; 0,0 et 0,3 pour l'iritis et 1,0 ; 1,0 et 1,0 pour l'opacit cornenne.
Conclusion
Dans nos conditions exprimentales, le produit irritant par voie oculaire chez le Lapin.
est considr
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1. INTRODUCTION
The objective of this study was to evaluate the potential of the test substanc 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., B5, 31st July 1992.
2. MATERIALS AND METHODS
2.1. TEST SUBSTANCE
2.1.1 Identification________
'
The test substance m i H ^ f l F u s e d in the study was supplied by Elf Atochem S.A.
Documentation supplied by the Sponsor identified the test substance as follows:
. name:
.
- protocol and labelling: ;
. batch number:
- protocol and labelling: <
. 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.
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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
. 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-Ore, r ranee). 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
ot the study were present.
*
(1) Jalsma, D.M.; Leach, C.L.; Hatoum, N.S.; Gibbons, R.D.; Roger, J.C.; Garvin, J.P.: Reducmg the number of rabbits in the Draize eye irritancy test: A statistical analysis 146-15?(198S8)COndUCted Ver 6 yearS' Fundamental and Applied Toxicology. JO: 1,
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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 corneal 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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11
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 ...................................................................................................................
. any swelling above normal (includes nictitating membranes) .................................. . obvious swelling with partial eversion of lids ........................................................... . swelling with lids about half-closed........................................................................... . swelling with lids more than half-closed ...................................................................
0
1 2* 3* 4*
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris) . blood vessels normal ..................................................................................................
. a number of blood vessels definitely hyperaemic (injected).....................................
. diffuse, crimson colour, individual vessels not easily discernible .......................... . diffuse, beefy r e d .........................................................................................................
0
1 2* 3*
Discharge . absence of discharge....................................................................... . slight discharge (does not include small amounts normally found
in inner canthus) .............................................................................. . discharge with moistening of lids and hairs adjacent to lids .....................................
. discharge with moistening of lids and hairs on wide area around the eye ...............
2 3
2.5.2 Iris lesions
. norm al.......................................................................................................
. markedly deepened rugae, congestion, swelling, moderate circum-corneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) ........... ............................................................
. no reaction to light, haemorrhage, gross destruction (any or all of these) ...............
1* 2*
2.5.3 Corneal lesions
Cornea (direct examination or, if necessary, with an Ultra-Violet lamp)
To determine the presence or absence of comeal 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.....................................................................................
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible ................................................................
. easily discernible translucent area, details of iris slightly obscured ........................ . nacrous areas, no details of iris visible, size of pupil barely discernible ................. . opaque cornea, iris not discernible through the opacity ...........................................
0
I* 2* 3* 4*
* indicates positive effect
Com pany Sanitized. Does not contain T S C A C B f
Area of opacity . one quarter (or less) but not zero ............................................................................. . greater than one quarter but less than a half ........................................................... . greater than one half but less than three quarters .................................................. . greater than three quarters up to whole area ..........................................................
1 2 3 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 > 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 values: . opacity of the cornea >3, . lesion of the iris > 1.5.
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.
p e H p s a y Sanitized. D oes not contain T S C A CSS
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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14
3. RESULTS (table 1)
Very slight to moderate conjunctival reactions were noted in all animals: very slight to mnrW t chemosis (grades 1 to 3), very slight to moderate conjunctival redness (grades 1 to 3) anri rU*
animals)Sh
diSCharge Were observed from daY 1 up to day 4 (1 animal) or 6 (tto
Slight them.
iritis
(grade
1)
was
observed
on
day
2 in
two
animals;
it
persisted
for
24
hours
in
one
of
Very slight comeal opacity (grade 1) was also noted in all animals on day 2; it persisted up to
Q3V h.
*
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 l.U, 1.0 and 1.0 for comeal opacity.
4. CONCLUSION
Under our experimental conditions, the test substanceL*,, _ considered irritant when administered by ocular route in rabbits.
was
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15
Table 1: Individual ocular examinations and mean values of the scores recorded at each reading (24,48 and 72 hours) for each animal
Rabbit Region number of eye
01 Conjunctivae
Description
Scores
of ocular
reactions lh 24h 48h 72h
D1 D2 D3 D4 D5 D6 D7
Chemosis
22 1 10 _ -
Redness
132 10 - -
Discharge
E200 0 - -
Mean irritation score (1)
1,3 2,0
0,7
Interpretation (+) (-)
(-) (-)
02 mV
Iris
Comeal opacity
Intensity Area
Other Fluorescein Conjunctivae
Chemosis Redness
Discharge
Iris
Comeal opacity
Intensity Area
Other Fluorescein Conjunctivae
Chemosis Redness
Discharge
0 1100 - -
0 1110 _ 032 10 - -
4 **4 * / UUUu __ 3 32 1 1 10 232 2 110
ESS0 00 0
000 0 00 0
0 11 100 0 032 100 0
4 **4 4 4 / UUu u / / 332 1 110 232 2 110
E200 00 0
0,7 1,0 2,0
2,0 2.3 (2). 0,0 1,0 2,0
2,0 2,3 0.7
(-) (-)
(+) (-)
(-) (-)
(+) (-)
Iris Comeal opacity
Intensity Area
0 10 0 0 0 0
0 11100 0 032 100 0
0,3
1,0 2,0
(-)
Other ' Fluorescein
44
44
44
4
/ u Uu 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
mU = Fluorescein batch No. 5253 / ' = Fluorescein not used = Scoring obscured by residual test substance =Whitish purulent discharge
= Ocular examination not performed
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APPENDICES Company Sanitized. Does not contain T S C A CW
1. Test article description
Com pany Sanitized. Does not contain T S C A C5I
TOXICOLOGY DEPARTMENT
CONFIDENTIAL 10 October 1996
elf atochem s.a.
La dfense 10, cedex42 92091 Paris-la-Dfense, France
TEST ARTICLE DESCRIPTION
18
IDENTITY
Test article name Chemical name
CAS number EINECS number Purity Origin and batch Batch Elf Atochem filing number
Elf Atochem, VSP 25-28
CAL 7443/96
PHYSICAL AND CHEMICAL PROPERTIES
Appearance Melting point [Boiling point [Flash point ISolubility
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 at room temperature
: December 1997
-
: incineration
Company sam
4 DOeSnofcontain TSC4C3J
2. Diet formula
Com pany Sanitized. Does not contain T S C A CBI
20
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 %
C e r e a ls .................................... Grain biproducts and legum es........................................
Vegetable proteins (soya bean meal, yeast) ............................ Vitamin and mineral mixture ...
43.8
49
4.2 3
AVERAGE ANALYSIS %
Calorific value (KCal/kg)....... 2200
Moisture ...................................... 10
Proteins........................................ 13
Lipids .....................................
2.7
Carbohydrates (N.F.E.) .......... 49.3 Fibre ............................................ 17
Minerals (ash) .............................
8
MINERALS (calculated in mg/kg) Nat. CMV val. val. Total
p ......... .... Ca ...... .... K ........ .... N a ...... .... Mg ..... ....
Mn ..... .... F e ....... .... Cu ........... Zn ........... Co ....... .... I .......... ... C l ........ ...
3500 4500 11600 400 2100
40 160 12 30
o.r 0 500
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
AMINO ACID VALUES (calculated in mg/kg)
Arginine ................................. Cystine ................................... Lysine ..................................... Methionine ............................. Tryptophan ............................ Glycine ...................................
6800 2100 4600 1600 1400 5200
FATTY ACID VALUES (calculated in mg/kg)
Palmitic acid.:.......................... 6400 Palmitoleic acid.......................... 0 Stearic acid............................... 600 Oleic acid.................................. 6400
Linoleic acid....,....................... 12100 Linolenic acid.......................... 2400
VITAMINS (calculated per kg)
Nat. CMV
val. val.
Total
Vitamin A 2850IU
Vitamin D3 30 IU
Vitamin B 1 4.3 mg
Vitamin B2 3.8 mg
Vitamin B3 16 mg
Vitamin B6
I mg
Vitamin B 12 0 mg
Vitamin E
16 mg
Vitamin K3
6 mg
Vitamin PP 55 mg
Folic acid ' 0 mg
Biotin
0 mg
Choline
850 mg
Meso-Inositol 0 mg
6500 IU 1000 IU
0 mg 0 mg 0 mg 1 mg 0 mg 10 mg 1 mg 5 mg 0 mg 0 mg 200 mg 0 mg
9350 IU 1030IU 4.3 mg 3.8 mg
16 mg 2 mg 0 mg 26 mg 7 mg 60 mg 0 mg
0 mg 1050 mg
0 mg
Available under quality "Control Ref.: 112 C Ml
(Ref. Doc. UAR: 1992)
- Tel: 69.04.03 .57 - Fax 69.04.81.97
lized. Does not contain SCBi
