Registration Dossier
Registration Dossier
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EC number: 700-945-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 28 January 1985 and 5 February 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in a manner similar to an existing guideline but does not meet all of the current guideline requirements.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U.S. 40 CFR Section 163.81-4 Federal Register August 22, 1978 and subsequently modified in accordance with the revised EPA Pesticide Assessment Guidelines of November 1982
- Deviations:
- not specified
- Principles of method if other than guideline:
- A group of six animals were used. A 0.1 ml dose was instilled into the conjunctival sac of one eye; the othere eye served as the untreated control. The animals were observed at 1 hour and the 1, 2, 3, 4 and 7 days in accordance with the method of Draize. The eyes were not washed.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid
- EC Number:
- 700-945-5
- Molecular formula:
- Complex UVCB substance
- IUPAC Name:
- Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid
- Test material form:
- other: Brown viscous liquid
- Details on test material:
- Description: Brown viscous liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals house in stainless steel cages with elevated wire mesh flooring (1/cage), were acclimated 5 days prior to testing and individually identified by an ear tag. Each cage was identified by a cage card. Husbandry conditions were as follows: Temperature 60 to 75 degrees C Relative Humidity 55+/_ 25% Light 12 hours light/dark cycle diet Wayne 15 % Rabbit Ration and tap water ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye served as the untreated control.
- Amount / concentration applied:
- 0.1 ml of the test material
- Duration of treatment / exposure:
- Single dose without washing through 7 day observation period
- Observation period (in vivo):
- 1 hour and the 1, 2, 3, 4 and 7 days
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 day (24 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 2 day ( 48 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 3 day (72 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 4 day
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 day (24 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 2 day (48 hour)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 3 day (72 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 4 day
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 day (24 hours)
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 2 day (48 hours)
- Score:
- 0.67
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 3 day(72 hours)
- Score:
- 0.67
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 4 day
- Score:
- 0.33
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0.5
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 day (24 hours)
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 2 day (48 hours)
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 3 day (72 hours)
- Score:
- 0.67
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 4 day
- Score:
- 0.67
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0.5
- Reversibility:
- not fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for eye irritation.
- Executive summary:
A group of six animals were used. A 0.1 ml dose was instilled into the conjunctival sac of one eye; the other eye served as the untreated control. The animals were observed at 1 hour and the 1, 2, 3, 4 and 7 days in accordance with the method of Draize. The eyes were not washed. The mean 24, 48, and 72 hour mean cornea, iris, conjuctival erythema and chemosis were 0.0, 0.0, 0.78, and 0.89, respectively. Conjunctival erythema and chemosis showed some evidence of reversibility but was not fully reversible by day 7 when the study was terminated. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for eye irritation.
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