Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
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. No test material concentration and dose defined.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981

Materials and methods

Principles of method if other than guideline:
A modification of the Maguire method was adopted. The method derives from the "Split-adjuvant" technique, in which chemical allergen and Freund´s adjuvant are administered separately to the skin rather than as an emulsion.
The test procedure consisted of topical application of a 0.1 ml aliquot of the test material to the clipped and depilated backs of 10 guinea pigs for four times in 10 days. At the time of the third application, 0.2 ml of Freund´s adjuvant was injected intradermally at one point adjacent to the insult site. After a 2-week rest period, the guinea pigs were challenged on the clipped flanks with the test material on one flank and a solvent on the other flank. The challenge site was evaluated for erythema and edema at 24 and 48 hours. A moderate erythema and/or edema in two or more guinea pigs would be considered sufficient to classify the test material as a potential human skin sensitizer.
GLP compliance:
not specified
Type of study:
other: Maguire method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,2-Benzene-dicarboxylic acid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: epicutaneous, no further data given
Vehicle:
no data
Concentration / amount:
no data
Challengeopen allclose all
Route:
other: epicutaneous, no further data given
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Results
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
no data
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.

Any other information on results incl. tables

0 of 10 tested animals showed effects.

Applicant's summary and conclusion

Executive summary:

In a modiefied method of the Maguire method the test procedure consisted of topical application of a 0.1 ml aliquot of the test material to the clipped and depilated backs of 10 Hartley guinea pigs for four times in 10 days. At the time of the third application, 0.2 ml of Freund´s adjuvant was injected intradermally at one point adjacent to the insult site. After a 2-week rest period, the guinea pigs were challanged on the clipped flanks witzh the test material on one flank and a solvent on the other flank. The challenge site was evaluated for erythema and edema at 24 and 48 hours. A moderate erythema and/or edema in two or more guinea pigs was considered sufficient to classify the test material as a potential human skin sensitizer. In 0/10 animals effects were observed, therefore the test substance was not found to be sensitising.