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EC number: 248-145-0 | CAS number: 26966-75-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Detailed study report, pre GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Code of federal Regulations vol 36 title 16, Section 1500.42, 1973.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3(or 4)-methylbenzene-1,2-diamine
- EC Number:
- 248-145-0
- EC Name:
- 3(or 4)-methylbenzene-1,2-diamine
- Cas Number:
- 26966-75-6
- Molecular formula:
- C7H10N2
- IUPAC Name:
- 3(or 4)-methylbenzene-1,2-diamine
- Details on test material:
- Maintained, prepared and extracted under nitrogen to prevent degradation
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Weight between 2.0 and 2.5 kg, housed and fed individually in accord with SOPs.
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- Test solution prepared at 5% in fresh boiled distilled water.
- Duration of treatment / exposure:
- Eyes were not rinsed after the exposure
- Observation period (in vivo):
- 2, 24, 48, 72 hrs, 4, 7 days after instillation.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Test material delivered in 0.1 ml of 5% solution in left eye, the untreated right eye as control.
cornea examined at 24 h and at 7 days using 2% fluorescine solution.
Eyes not rinsed after treatment.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Slight conjunctival redness was produced in all animals at 2, 24 and 48 hours after instillation of the test material.
Two of the six animals exhibited a slight reddening of the iris at 24 hours.
No irritation remained in any animal at 72 hours.
Any other information on results incl. tables
Individual animal data , draize scores
EYE IRRITATION IN RABBITS
Animal Number |
Cornea |
Iris |
Conjunctivae |
Total Score Per Animal |
|||
A x B x 5 |
A x 5 |
(A + B + C) x 2 |
|||||
2 Hours |
|||||||
A |
B |
A |
A |
B |
C |
4 |
|
1 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
2 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
3 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
4 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
5 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
6 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
24 Hours |
|||||||
1 |
0 |
0 |
1 |
1 |
1 |
0 |
9 |
2 |
0 |
0 |
1 |
2 |
1 |
0 |
11 |
3 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
4 |
0 |
0 |
0 |
2 |
1 |
1 |
8 |
5 |
0 |
0 |
0 |
2 |
1 |
1 |
8 |
6 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
48 Hours |
|||||||
A |
B |
A |
A |
B |
C |
||
1 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
3 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
4 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
5 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
6 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
72 Hours |
|||||||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 days |
|||||||
A |
B |
A |
A |
B |
C |
||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 Days |
|||||||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Conclusions:
- Not classified as irritating to eyes according to Regulation (EC) No 1272/2008
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