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EC number: 931-384-6 | CAS number: -
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between June 1st, 1992 and June 18th, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A dose response was examined, well documented study. Restrictions due to it was not a GLP study, and there was no observations beyond 72 hours to assess reversibility.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA 16CFR1500
- Deviations:
- no
- GLP compliance:
- no
Test material
- Details on test material:
- - Physical state: liquid at room temperature
- Analytical purity: not provided
- Stability under test conditions: stable
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- other: Mineral oil
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 3 male and 3 female/group (2 groups)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- undiluted test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Remarks:
- undiluted test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- undiluted test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Remarks:
- undiluted test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- not specified
- Other effects:
- In groups treated with undiluted test substance:
Blistered appearance to the conjunctiva were observed in 6/6, 4/6, and 1/6 animals at 24, 48 and 72 h, respectively;
Blistered appearance to the nictitating membrane were observed in 2/6, 0/6, and 0/6 animals at 24, 48 and 72 h, respectively;
Any other information on results incl. tables
6/6 animals treated showed evidence of positive corneal, iritic, or conjunctival changes in response to undiluted (100%) test substance.
Table 1: Mean Scores (24,48 and 72 hours) for 100% Test Substance
Corneal Opacity |
Iris |
Conjunctival Erythema |
Conjuctival Edema |
1.3 |
0.8 |
1.5 |
2.1 |
1/6 animals tested showed evidence of positive corneal, iritic, or conjuctival changes in response to 50% w/w test substance.
Table 2: Mean Scores (24,48 and 72 hours) for 50% w/w Test Substance
Corneal Opacity |
Iris |
Conjunctival Erythema |
Conjuctival Edema |
0.0 |
0.0 |
0.3 |
0.2 |
No evidence of corrosion was noted in response to the test substance at 100% or 50%w/w concentrations.
No observations were made beyond 72 hours, therefore, the reversibility of the effects could not be assessed.
The mineral oil vehicle used as the dilute was determined to be a non-irritant in a separate study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The undiluted (100%) test substance is classified as an irritant, whereas the test substance at 50% w/w is classified as a nonirritant.
- Executive summary:
An eye irritation study was performed using male New Zealand White rabbits according to the definition of the FHSA 16CFR1500. Two groups of 6 rabbits (3 male and 3 female) were administered with a single dose of 0.1 ml test material to one eye of each animal, and eyes were examined and graded for ocular reaction at approximately 24, 48 and 72 h following dose administration using the Draize method. Following the 24 h reading the eyes were rinsed with physiological saline. Based on these scores, the undiluted (100%) test substance is classified as an irritant, whereas the test substance at 50% w/w is classified as a nonirritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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