Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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: Brief report of the testing results of 72 substances

Data source

Reference
Reference Type:
publication
Title:
A collection of Guinea pig sensitization test results -grouped by chemical class
Author:
Rao KS et al. (1981)
Year:
1981
Bibliographic source:
Drug and Chemical Toxicology 4 (4), 331-351

Materials and methods

Principles of method if other than guideline:
Method: other: according to Lansteiner and Jacobs (1935) modified by Draize et al (1944): Topical application of a 0.1 ml aliquot of the substance to the clipped and depilated backs of 10 guinea pigs per test material 4 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. The challenge site was evaluated for erythema and edema at 24 and 48 hours. positive control:  diglycidyl ether of 2,2-di-(p,p'-hydroxyphenyl)propane
GLP compliance:
not specified
Type of study:
split adjuvant test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: p-chlorophenyl isocyanate, no data on purity

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: a 0.1 ml aliquot was applied on the backs of 10 guinea pigs four times in 10 days. at the time of the third application, 0.2 ml of Freund's adjuvant was injected intradermally. after a 2-week rest period, the Guinea pigs were challenged
Vehicle:
no data
Concentration / amount:
0.1 ml aliquot
Challengeopen allclose all
Route:
other: no data
Vehicle:
no data
Concentration / amount:
0.1 ml aliquot
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
no data
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

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

method:

Topical application of a 0.1 ml aliquot of the substance to
the clipped and depilated backs of 10 guinea pigs per test
material 4 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.
The challenge site was evaluated for erythema and edema at
24 and 48 hours.

result:

No guinea pig (0/10) showed a positive result, whereas the
positive control was functional.