Registration Dossier
Registration Dossier
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EC number: 212-836-5 | CAS number: 873-32-5
Endpoint summary
Administrative data
Description of key information
GLP guideline studies are available according to OECD 404 and 405 (both Huntington Research Centre, 1990). 2-chlorobenzonitrile is not irritating to the skin but causes serious eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: propylene glycole
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 4 d
- Number of animals:
- > 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No dermal irritation after the application of 2-Chlorobenzonitrile was observed.
- Executive summary:
Three New Zealand White rabbits (f) were treated with 0.5 g 2 -Chlorobenzonitrile on previously shaved intact skin covered with a semi-occilsive dressing for 4 hours.
Skin irritation was assessd approx. 30 min after removal of the dressin, after 24, 48, and 72 h.
No skin irritation was observed.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- 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
- 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
- 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.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
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 |
|||
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
A single semi-occlusive application of 0.5 g 2-Chlorobenzonitrile to the intact skin of 3 New Zealand White rabbits for 4 hours according to OECD 404 elicited no dermal irritation (HRC, 1990). Examination of the treated skin was made on approximately 30 min after removal of the patches and on days 2, 3, and 4 after removing the gauze pads according to the OECD scoring system.
In a GLP guideline study according to OECD 405 (1987) 0.1 ml (approx. 90 mg) 2-Chlorobenzonitrile was instilled into the lower everted eye lid of one eye of each of 3 female New Zealand White rabbits (HRC, 1990). 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 showed corneal effects >=1 after 24 -72h.
Effects on eye irritation: irritating
Justification for classification or non-classification
2-chlorobenzonitrile is not irritating to the skin according to the results of an OECD 404 study.
In an OECD 405 study, two of three animals show corneal effects >=1 after 24 -72h. According to Regulation (EC) No 1272/2008 the classification “H319: Causes serious eye irritation” is warranted.
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