Registration Dossier
Registration Dossier
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EC number: 212-836-5 | CAS number: 873-32-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-chlorobenzonitrile
- EC Number:
- 212-836-5
- EC Name:
- 2-chlorobenzonitrile
- Cas Number:
- 873-32-5
- Molecular formula:
- C7H4ClN
- IUPAC Name:
- 2-chlorobenzonitrile
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Test material form:
- solid
Constituent 1
impurity 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Duration of treatment / exposure:
- Single instillation of 0.1 ml of the test substance (approx. 90 mg of 2-Chlorobenzonitrile) into the lower everted eye lid of one eye of each animal.
- Observation period (in vivo):
- Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation
- Number of animals or in vitro replicates:
- 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 813
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal: 813
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 813
- Time point:
- 24/48/72 h
- Score:
- >= 1 - < 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 813
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 840
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal: 840
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 840
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 840
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 841
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: 841
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 841
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 841
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 day
Any other information on results incl. tables
Ocular reactions elicited by 2-Chlorobenzonitrile
Rabbit Number and sex |
Body weight (Day 1) |
Region of Eye |
One hour |
Day after instillation |
|||||
1 |
2 |
3 |
4 |
7 |
|||||
813 female |
2665 g |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
2 |
1 |
0 |
0 |
0 |
0 |
||
Chemosis |
1 |
1 |
0 |
0 |
0 |
0 |
|||
840 female |
2770 g |
Cornea |
Density |
0 |
2 |
2 |
1 |
0 |
0 |
Area |
0 |
1 |
1 |
1 |
0 |
0 |
|||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
2 |
1 |
0 |
0 |
0 |
0 |
||
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
|||
841 female |
3020 g |
Cornea |
Density |
0 |
1 |
1 |
1 |
1 |
0 |
Area |
0 |
1 |
1 |
1 |
1 |
0 |
|||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
2 |
1 |
0 |
0 |
0 |
0 |
||
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
|||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2-Chlorobenzonitrile elicited transient, corneal opacification and temporary well-defined conjunctival reactions.
- Executive summary:
In a GLP guideline study according to OECD 405 (1987) 0.1 ml (approx. 90 mg) 2-Chlorobenzonitrile was installed into the lower everted eye lid of one eye of each of 3 female New Zealand White rabbits. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation. All animals were observed daily for signs of ill health or toxic signs.The test material elicited transient, corneal opacification and temporary well-defined conjunctival reactions.
Two of three animals show corneal effects >=1 after 24 -72h. Based on the scoring result the classification “H319: Causes serious eye irritation” is warranted.
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