Registration Dossier
Registration Dossier
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EC number: 234-603-7 | CAS number: 12014-93-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 30 May 1994 to 30 August 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dicerium trisulphide
- EC Number:
- 234-603-7
- EC Name:
- Dicerium trisulphide
- Cas Number:
- 12014-93-6
- Molecular formula:
- Ce2S3
- IUPAC Name:
- dicerium trisulphide
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
- Details on test material:
- - Name of test material (as cited in study report): Cerium sulphide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.7 kg
- Housing: animals were housed individually in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cm). Each cage was equiped wity a food container and a water bottle.
The housing conditions (temperature, relative humidity and light/dark cycle) were checked monthly.
- Diet: 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.
- Water: ad libitum, drinking water filtered by a F.G. Millipore membrane (0.22µm) and contained in bottles.
Bacteriological and chemical analysis of water and detection of possible contaminants (pesticides, heavy metals and nitrosamines) are performed periodically. There were no contaminants in the diet or water at levels likely to have influenced the outcome of the study.
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30-70 %
The temperature and relative humidity were recorded continuously and records retained.
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: 21/06/1994 -24/06/1994
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye, which remained untreated, served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test material in its original form. - Duration of treatment / exposure:
- Single introduction into the conjunctival sac of the left eyes of 3 animals 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.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration of the test substance.
When there is no evidence of irritation after 72 hours, the study is ended. - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No, the eyes were not rinsed after administration of the test substance.
SCORING SYSTEM: Scale of 0 to 2 for Iris lesions and scale of 0 to 4 for all the other ocular reactions (according to OECD Guideline 405).
TOOL USED TO ASSESS SCORE: Fluorescein (batch no. 2815)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: score of 1 at the 1 hour time point
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Remarks on result:
- other: score of 2 at 1 hour and score of 1 at 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal#1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: red coloration by the test substance only at the 1 hour time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Remarks on result:
- other: red coloration by the test substance at the 1 hour time point and score of 2 at the 24 hour time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal#1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal#1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- other: discharge
- Basis:
- other: all 3 animals
- Time point:
- other: 1 hour
- Remarks on result:
- other: scoring obscured by residual test substance
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- animal#1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- - After introduction of the test substance, slight conjunctival irritation (chemosis: scores of 1 or 2; redness: score of 2 was observed in all 3 animals.
- The mean scores over 24, 48 and 72 hours for individual animals were lower than 1.0 for chemosis and redness.
- On day 3, conjunctivai irritation had reversed.
- No iridial irritation and no corneal opacity were observed.
- The test substance obscured evaluation of discharge on day 1. - Other effects:
- No other effects.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The mean scores for chemosis, redness, iris and degree of corneal opacity for 2 out of the 3 animals did not reach the criteria values for irritation. Under the experimental conditions of the study, the test substance, Dicerium trisulphide, was considered as non-irritant when administered by ocular route in rabbits.
- Executive summary:
The potential of the test substance Dicerium trisulphide 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.) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
Method
Having confirmed that the test substance was not irritant or corrosive when administered by cutaneous route, a single dose of 0.1 g of the test substance in its original form was placed into the conjunctival sac of the left eyes of 3 male New Zealand White rabbits.
The eyes were not rinsed following the administration of the test substance.
Ocular reactions were observed approximately 1, 24, 48 and 72 hours after the administration.
The mean score of the values recorded for each animal after 24, 48 and 72 hours was calculated.
The interpretation of results was carried out according to the classification criteria laid down in Directive 93/21/E.E.C. Commission Directive of 27th April 1993 adapting to technical progress for the eighteenth time Council Directive 67/548/E.E.C.
Results
Slight conjunctival irritation (chemosis: score of 1 or 2, redness: score of 2) occurred for up to 24 hours post-introduction.
No iridial irritation and no corneal opacity were observed.
Conclusion
The mean scores for chemosis, redness, iris and degree of corneal opacity for 2 out of the 3 animals did not reach the criteria values for irritation. Under the experimental conditions of the study, the test substance, Dicerium trisulphide, was considered as non-irritant when administered by ocular route in rabbits.
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