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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

Referenceopen allclose all

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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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

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

 

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
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.