Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The test substance m-chloroaniline was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on female guinea pigs. The following test compound concentrations were used in this test:
Intradermal induction: 5 %
Topical induction: 50 %
1. Challenge: 50 %
2. Challenge: 25% and 12%
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
CAS no.: 108-42-9
content: 99.2%
molecular weight. 127.58 g/mol
appearance: yellow liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor:DHPW
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5 %
Topical induction: 50 %
1. Challenge: 50 %
2. Challenge: 25% and 12%
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5 %
Topical induction: 50 %
1. Challenge: 50 %
2. Challenge: 25% and 12%
No. of animals per dose:
Three goups of experimental animals were randomly established for the main test:
One test substance group consisting of 20 animals (no 21 to 40) and 2 control groups consisting of 10 animals each (no 1 to 10, and 11 to 20)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
reddening + edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
50%
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
reddening + edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
reddening + edema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
25%
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
reddening + edema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
12%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
reddening + edema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
12%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
reddening + edema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 12%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
reddening + edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: reddening + edema.
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
50%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
reddening + edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: reddening + edema.

Any other information on results incl. tables

After the 1st challenge, 95% of the test group animals and 70% of the control animals revealed skin changes on the application area of the test substance.

After the 2nd challenge, the 25% and the 12% test solution provokes skin changes on 70% and 15% on the test group animals, respectively. The animals of the control group showed no reactions.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Executive summary:

The test substance m-chloroaniline was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on female guinea pigs. The following test compound concentrations were used in this test:

Intradermal induction: 5%, Topical induction: 50%, 1st Challenge: 50 %, 2nd Challenge: 25% and 12%.

Under the condition of the maximisation assay, m-chloroaniline is positive. Based on these data a classification as R43 (GHS: Skin Sens. 1B; H317) is justified.