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Toxicological information

Skin sensitisation

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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: guiedline study according OECD 406

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
n a guinea pig maximisation test according Magnusson and Kligman 20 male animals (control: 10 male animals) per test group were used.
1. Induction: Intradermal application into the back of 0.1 ml of a 5% solution of p-Chlorotoluene; one week later:
2. Induction: topical application of a plaster containing 0.5 ml undiluted p-chlorotoluene which was fixed by alufole (occlussive condition)
3 weeks after intradermal induction:
Challange with 0.5 ml of undiluted p-chlorotoluene by dermal application, covered with a plaster, for 24 hours.
Afterwards treatment areas were rinsed with physiological saline-solution.
Evaluation: reading was carried out 48 and 72 hours post start of the challenge; evaluation by comparison of the reacting animals between test and control group.
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.78 %

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Cremophor E1 in physiological saline
Concentration / amount:
intradermal induction: 5 %
topical induction: 100 %
provocation: 100 %
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: Cremophor E1 in physiological saline
Concentration / amount:
intradermal induction: 5 %
topical induction: 100 %
provocation: 100 %
No. of animals per dose:
20
Details on study design:
1st application: Induction 5 % intracutaneous
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 100 % semiocclusive

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no erythema or edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no erythema or edema.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no erythema or edema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no erythema or edema.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

method: o-chlorotoluene was tested in a guinea pig maximisation test according Magnusson and Kligman. 20 male animals (control: 10 male animals) per test group were used.

1. Induction: Intradermal application into the back of 0.1 ml of a 5% solution of o-Chlorotoluene; one week later:

2. Induction: topical application of a plaster containing 0.5 ml undiluted o-chlorotoluene which was fixed by alufole (occlussive condition) 3 weeks after intradermal induction:

Challenge with 0.5 ml of undiluted o-chlorotoluene by dermal application, covered with a plaster, for 24 hours.

Evaluation: reading was carried out 48 and 72 hours post start of the challenge; evaluation by comparison of the reacting animals between test and control group.

result: negative, none of the animals in the test group (0/20) revealed any signs of erythema or edema at 48 or 72 hours after challenge