3-chloro-p-toluidine

Skin sensitisation

Administrative data

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.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1979

Materials and methods

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.

Test material

Test material information

Constituent 1

Reference substance name:

3-chloro-p-toluidine

EC Number:

202-446-3

EC Name:

3-chloro-p-toluidine

Cas Number:

95-74-9

Molecular formula:

C7H8ClN

IUPAC Name:

3-chloro-4-methylaniline

Details on test material:

IUCLID4 Test substance: other TS: it is not specified if 3-chloro-p-toluidine was used as free base or as hydrochloride

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: distilled water

Induction 2

Concentration / amount:

10% solution in distilled water. 50 mg of test substance (0.5 cc) was applied.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: distilled water

Challenge 2

Concentration / amount:

10% solution in distilled water. 50 mg of test substance (0.5 cc) was applied.

No. of animals per dose:

10

Results and discussion

In vivo (non-LLNA)

Results

Results 1

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).

Results 2

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)..

Results 3

Group:

positive control

Remarks on result:

other: no data reported

Results 4

Group:

negative control

Remarks on result:

other: no data reported

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.