Registration Dossier
Registration Dossier
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EC number: 202-855-7 | CAS number: 100-47-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FDA Fed.Reg. 28 (119), 5582, 1963
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Benzonitrile
- EC Number:
- 202-855-7
- EC Name:
- Benzonitrile
- Cas Number:
- 100-47-0
- Molecular formula:
- C7H5N
- IUPAC Name:
- benzonitrile
- Reference substance name:
- Toluene
- EC Number:
- 203-625-9
- EC Name:
- Toluene
- Cas Number:
- 108-88-3
- Molecular formula:
- C7H8
- IUPAC Name:
- toluene
- Reference substance name:
- Benzaldehyde
- EC Number:
- 202-860-4
- EC Name:
- Benzaldehyde
- Cas Number:
- 100-52-7
- Molecular formula:
- C7H6O
- IUPAC Name:
- benzaldehyde
- Reference substance name:
- Terephthalonitrile
- EC Number:
- 210-783-2
- EC Name:
- Terephthalonitrile
- Cas Number:
- 623-26-7
- Molecular formula:
- C8H4N2
- IUPAC Name:
- terephthalonitrile
- Reference substance name:
- Benzene-1,3-dicarbonitrile
- EC Number:
- 210-933-7
- EC Name:
- Benzene-1,3-dicarbonitrile
- Cas Number:
- 626-17-5
- Molecular formula:
- C8H4N2
- IUPAC Name:
- isophthalonitrile
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- upon application eye closed for one second and subsequently not rinsed
- Observation period (in vivo):
- eyes examined at 24, 48, 72 hr and 7 days after instillation
- 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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
Any other information on results incl. tables
Individual scores awarded to the ocular lesions elicited by benzonitril using FDA-scoring scale
|
|
|
Conjunctivae |
|
Rabbit No. |
Cornea |
Iris |
Redness |
Chemosis |
After 24 hours |
||||
13 |
0 |
0 |
1 |
0 |
14 |
0 |
0 |
1 |
0 |
15 |
0 |
0 |
1 |
0 |
16 |
0 |
0 |
1 |
1 |
17 |
0 |
0 |
1 |
0 |
18 |
0 |
0 |
1 |
1 |
After 48 hours |
||||
13 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
15 |
0 |
0 |
1 |
0 |
16 |
0 |
0 |
1 |
0 |
17 |
0 |
0 |
1 |
0 |
18 |
0 |
0 |
1 |
0 |
After 72 hours |
||||
13 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
15 |
0 |
0 |
1 |
0 |
16 |
0 |
0 |
1 |
0 |
17 |
0 |
0 |
1 |
0 |
18 |
0 |
0 |
1 |
0 |
After 7 days |
||||
13 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
15 |
0 |
0 |
0 |
0 |
16 |
0 |
0 |
0 |
0 |
17 |
0 |
0 |
0 |
0 |
18 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- Upon application into the eye benzonitril caused slight lesions of the conjunctivae in all 6 rabbits. After seven days all treated eyes were normal again.
- Executive summary:
In a primary eye irritation study 0,1 ml of benzonitril as provided by the study owner without vehicle was instilled into the conjunctival sac of one eye of an adult New Zealand rabbits (in total 6) secured for one second (eyes subsequently not washed). The animal eyes were then examined after 24, 48 and 72 hours and finally after 7 days. Irritation was scored by the method of FDA-scoring scale.
Upon application into the eye benzonitril caused slight lesions of the conjunctivae in all (six) rabbits. After seven days all treated eyes were normal again. According to the FDA-standards benzonitril is not considered to be an eye irritant.
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