Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The purity of the test substance was unknown. The protocol was not described in details.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Sensitization to nordihydro-guaiaretic acid.
Author:
Golberg L.
Year:
1963
Bibliographic source:
Food and Cosmetics Toxicology, 1, 114.
Reference Type:
publication
Title:
Studies on allergy towards some simple chemical substances
Author:
Griepentrog F.
Year:
1961
Bibliographic source:
Arzneimittel-Forsch., 11, 920-922.

Materials and methods

Principles of method if other than guideline:
Guinea-pigs were injected with the test substance intradermally on 10 successive days. Three weeks after the injections, the test substance was
rubbed onto the injection site in the form of a 1% solution or suspension in peanut oil.
GLP compliance:
not specified
Type of study:
other: sensitization test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The origin of guaiacol was not reported and its purity was unknown.

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:
intradermal
Vehicle:
peanut oil
Concentration / amount:
1% in peanut oil
Challengeopen allclose all
Route:
other: substance rubbed onto injection sites
Vehicle:
peanut oil
Concentration / amount:
1% in peanut oil
No. of animals per dose:
no data
Details on study design:
Guinea-pigs were injected with the test substance intradermally on 10 successive days. Three weeks after the injections, the test substance was
rubbed onto the injection site in the form of a 1% solution or suspension in peanut oil and the area was examined 1, 2 and 3 days following the
application

Results and discussion

Any other information on results incl. tables

Guaiacol did not evoke skin reactions.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Not sensitizing
Executive summary:

In a sensitizing study (Goldberg, 1963), guinea-pigs were injected with Gaiacol intradermally on 10 successive days. Three weeks after the injections, the test substance was rubbed onto the injection site in the form of a 1% solution or suspension in peanut oil and the area was examined 1, 2 and 3 days following the application.

Gaiacol did not induce sensitization, and it should not be classified.