Registration Dossier

Administrative data

Description of key information

3-chloro-p-toluidine was tested for skin sensitisation in a modified Buehler test.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined.
Principles of method if other than guideline:
In a sensitization test 10 hair-clipped healthy female Hartley guinea pigs weighing 400 -500 g each were used. A modified Buehler and Griffith (1975) method was used (modifications included 24 -hour, instead of 6 -hour, occlusion of the first inductive application). A total of 3 inductive applications were performed on the backs of the animals at the rate of 1 application per week. Challenge doses were applied 2 and 3 weeks after the last inductive application. 50 mg of each compound (0.5 cc) was applied with a 1 cc syringe and the animals were immobilized on a restraining board for 6 hours. The first inductive and the challenge application remained under occlusion for 24 hours; the second and third induction for 6 hours. 24 hours after each application, the sites were scored for erythema based on a 0 (no erythema) to 4 (severe erythema) scale according Draize.
GLP compliance:
not specified
Type of study:
other: modified method by Buehler and Griffith
Justification for non-LLNA method:
Data were published in the year 1979.
Species:
guinea pig
Strain:
Hartley
Sex:
female
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water
Concentration / amount:
10% solution in distilled water. 50 mg of test substance (0.5 cc) was applied.
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water
Concentration / amount:
10% solution in distilled water. 50 mg of test substance (0.5 cc) was applied.
No. of animals per dose:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 mg
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
slight erythema (score of 1)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 mg. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: slight erythema (score of 1).
Reading:
2nd reading
Group:
test chemical
Dose level:
50 mg
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
2 well-defined erythema (score of 2), and 8 slight erythema (score of 1).
Remarks on result:
other: Reading: 2nd reading. Group: test group. Dose level: 50 mg. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 2 well-defined erythema (score of 2), and 8 slight erythema (score of 1)..
Group:
positive control
Remarks on result:
other: no data reported
Group:
negative control
Remarks on result:
other: no data reported

No irritation due to treatment was observed during the inductive period with the test substance. 24 hours after the first challange, 6 of 10 animals responded with slight erythema (score of 1). After the second challenge application of the test substance, all animals had some reaction: 2 well-defined erythema (score of 2), and 8 slight erythema (score of 1).

50 mg of the substance as a 10 % aqueous solution was applied to the back of each of 10 female guinea pigs; the test was conducted according to the following scheme:

induction exposure: initial exposure for 24 hours under  occlusion, a secondary exposure for 6 hours after one week, another exposure of 6 hours during the third week; challenge exposure: first challenge application with 24 hours of exposure under occlusion occurring 2 weeks after the last inductive treatment, a renewed application 1 week later; the treated sites were examined 24 hours after each application  

Effects: no irritation due to treatment was observed during the inductive period; 24 hours after the first challenge application, 6 of the 10 animals responded with slight erythema; after the second challenge exposure, all 10 animals had some reaction: 2 well-defined erythema and 8 slight erythema

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Executive summary:

In a sensitization test 10 hair-clipped healthy female Hartley guinea pigs weighing 400 -500 g each were used. A modified Buehler and Griffith (1975) method was used (modifications included 24 -hour, instead of 6 -hour, occlusion of the first inductive application). A total of 3 inductive applications were performed on the backs of the animals at the rate of 1 applikation per week. Challange doses were applied 2 and 3 weeks after the last inductive application. 50 mg of each compound (0.5 cc) was applied with a 1 cc syringe and the animals were immobilized on a restraining board for 6 hours. The first inductive and the challange application remained under occlusion for 24 hours; the second and third induction for 6 hours. 24 hours after each application, the sites were scored for erythema an a 0 (no erythema) to 4 (severe erythema) scale according Draize (1944).

No irritation due to treatment was observed during the inductive period with the test substance. 24 hours after the first challange, 6 of 10 animals responded with slight erythema (score of 1). After the second challenge application of the test substance, all animals had some reaction: 2 well-defined erythema (score of 2), and 8 slight erythema (score of 1). Due to this result the test substance was found to be sensitizing in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

3-chloro-p-toluidine was tested for skin sensitisation in a modified Buehler test (modifications included 24-hour, instead of 6-hour, occlusion of the first inductive application). A total of 3 inductive applications were performed on the backs of the animals at the rate of 1 application per week. Challenge doses were applied 2 and 3 weeks after the last inductive application.

No irritation due to treatment was observed during the inductive period with the test substance. 24 hours after the first challenge, 6 of 10 animals responded with slight erythema (score of 1). After the second challenge application of the test substance, all animals had some reaction: 2 well-defined erythema (score of 2), and 8 slight erythema (score of 1).

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Skin Sens. 1 ( H317: May cause an allergic skin reaction) is justified.