Registration Dossier
Registration Dossier
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EC number: 238-339-3 | CAS number: 14367-46-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from NTRL reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Initial Submission: Acute toxicity of the test chemical in rabbits, rats, guinea pigs with Cover Letter dated 082692
- Author:
- NTRL report
- Year:
- 1 992
- Bibliographic source:
- NTRL report, 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the dermal sensitization potential of the test chemical in guinea pigs
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- p-anisylamine
- EC Number:
- 219-247-2
- EC Name:
- p-anisylamine
- Cas Number:
- 2393-23-9
- Molecular formula:
- C8H11NO
- IUPAC Name:
- p-Anisylamine
- Test material form:
- other: colorless liquid
- Details on test material:
- - Name of test material: 4-Methoxybenzylamine
- IUPAC name: p-anisylamine
- Molecular formula: C8H11NO
- Molecular weight: 137.181 g/mole
- Smiles :O(c1ccc(cc1)CN)C
- Inchl: 1S/C8H11NO/c1-10-8-4-2-7(6-9)3-5-8/h2-5H,6,9H2,1H3
- Substance type: Organic
- Physical state: Liquid (Colorless to pale yellow)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Weight at study initiation: range: 356 - 461 g
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- not specified
- Concentration / amount:
- Induction: 1%
Challenge: 1% - Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- Induction: 1%
Challenge: 1% - Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- Negative control used but name not mentioned
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data available
In vitro / in chemico
- Other effects / acceptance of results:
- no data available
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- 5 animals showed slightly greater degree of erythema than control animals.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or other dermal reactions were observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Sensitizer
- Conclusions:
- 5 animals showed slightly greater degree of erythema than control animals. Five of ten animals induced with the test material in Freund's Adjuvant responded to challenge with a slightly greater degree of erythema than seen in animals previously injected with Freund's Adjuvant only.
Based on these observations, the test chemical was considered to be sensitizing to guinea pig skin. - Executive summary:
Guinea pig Maximization assay was performed to determine the degree of dermal sensitization caused by the test chemical. 10 female Hartley guinea pigs were used for the study.
During the induction phase,the test chemical in Freund's Adjuvant was injected into the skin of guinea pigs, then 1% of the test material was applied onto the skin.Negative control was also used (name not specified). After few days, the induced guinea pigs were challenged with 1% test chemical and observed for signs of erythema.
5 animals showed slightly greater degree of erythema than control animals. Five of ten animals induced with the test material in Freund's Adjuvant responded to challenge with a slightly greater degree of erythema than seen in animals previously injected with Freund's Adjuvant only.
Based on these observations, the test chemical was considered to be sensitizing to guinea pig skin.
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