Registration Dossier
Registration Dossier
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EC number: 201-964-7 | CAS number: 90-05-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- 1 963
- Bibliographic source:
- Food and Cosmetics Toxicology, 1, 114.
- Reference Type:
- publication
- Title:
- Studies on allergy towards some simple chemical substances
- Author:
- Griepentrog F.
- Year:
- 1 961
- 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
- Justification for non-LLNA method:
- Study conducted prior to the recognition of the LLNA test as the preferred in vivo test method to assess skin sensitisation.
Test material
- Reference substance name:
- Guaiacol
- EC Number:
- 201-964-7
- EC Name:
- Guaiacol
- Cas Number:
- 90-05-1
- Molecular formula:
- C7H8O2
- IUPAC Name:
- Phenol
- Details on test material:
- The origin of guaiacol was not reported and its purity was unknown.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 1% in peanut oil
- Day(s)/duration:
- 10 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: substance rubbed onto injection sites
- Vehicle:
- peanut oil
- Concentration / amount:
- 1% in peanut oil
- Day(s)/duration:
- single administration
- Adequacy of challenge:
- not specified
- 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
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- not specified
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- Not specified
- No. with + reactions:
- 0
- Remarks on result:
- other: no data available
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- not specified
- Remarks on result:
- other: No data available
Any other information on results incl. tables
Guaiacol did not evoke skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- 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.
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