Registration Dossier
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EC number: 205-132-4 | CAS number: 134-20-3
Skin sensitisation
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Fragrance raw materials monographs of test chemical
- Author:
- D. L. J. Opdyke
- Year:
- 1 979
- Bibliographic source:
- Food and Cosmetics Toxicology
- Reference Type:
- publication
- Title:
- THE IDENTIFICATION OF CONTACT ALLERGENS BY HUMAN ASSAY
- Author:
- ALBERT M. KLIGMAN
- Year:
- 1 966
- Bibliographic source:
- THE JOURNAL OF INVESTIGATIVE DERMATOLOGY, 1966
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- To evaluate the skin sensitizing potential of the test chemical in Human by Human Maximisation test.
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximisation test.
- Justification for non-LLNA method:
- no data available
Test material
- Reference substance name:
- Methyl o-aminobenzoate
- Cas Number:
- 134-20-3
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- Methyl o-aminobenzoate
- Test material form:
- liquid
- Details on test material:
- IUPAC name: 2-Aminobenzoic acid, methyl ester
Mol. formula: C8H9NO2
Molecular Weight: 151.1641 gm/mol
Smiles: c1(c(cccc1)N)C(OC)=O
InChI: 1S/C8H9NO2/c1-11-8(10)6-4-2-3-5-7(6)9/h2-5H,9H2,1H3
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Not applicable.
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Age: the preferred age range is 18 to 50 years.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 10%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- other: 1.0 ml of 5% aqueous sodium lauryl sulfate (SLS) was applied to a 1.5 inch square of Webril under occlusive conditons for 24 hours.
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 10%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: A provocative patch test consists of pre-treating the skin occlusively with 0.4 ml of 10% SLS on a 1.0" Webril square for one hour.
- No. of animals per dose:
- Group 1: 24 human volunteers
Group 2: 26 human volunteers - Details on study design:
- RANGE FINDING TESTS: no data available
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: total 5 exposures
- Exposure period: 48 hours
- Test groups: 2 (24 and 26)
- Control group: No data available.
- Site: forearm or back
- Frequency of applications: The procedure consists of five 48 hour exposures, each one preceded by a 24 hour pre-treatment with 5% SLS..
- Duration: 2 weeks
- Concentrations: 10% in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge:
- Exposure period: 48 hours
- Test groups: 2 (24 and 26)
- Control group: A control patch was necessary for the provocative test consisting of petrolatum applied for 48 hours to a site pretreated for one hour with 10% aqueous sodium lauryl sulfate.The allergen treated site was not regarded as positive unless it was clearly more inflammatory than the control site.
- Site: forearm or back
- Concentrations: 10% in petrolatum
- Evaluation (hr after challenge): The challenge reaction was read immediately after removal of the 48 hour patch and again in another two days - Challenge controls:
- A control patch was necessary for the provocative test consisting of petrolatum applied for 48 hours to a site pretreated for one hour with 10% aqueous sodium lauryl sulfate.The allergen treated site was not regarded as positive unless it was clearly more inflammatory than the control site.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% in Petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- No skin sensitization reaction observed.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 26
- Clinical observations:
- No skin sensitization reaction
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No skin sensitization reaction observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing.
- Conclusions:
- No dermal reactions were observed on the skin of the volunteers. Therefore, the test chemical was considered to be not sensitizing to humans. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
- Executive summary:
A human maximization study was performed to assess the dermal sensitization potential of the test chemical. During the induction exposure, the sensitizing patches were applied to an extremity, either the forearm or the lower leg in the calf region. The entire series of patches were applied to exactly the same site. The procedure was as follows: 1.0 ml of 5% aqueous sodium lauryl sulfate (SLS) was injected on to the Webril patches and fastened to an extremity under occlusive conditions for 24 hours. To the same site, a 48 hour occlusive patch with 10% test chemical in petrolatum was applied to the skin of 24 and 26 human volunteers. The procedure of alternating 24 hour irritant i.e 24 hour pre-treatment with 5% SLS and 48 hour allergen patches were repeated for a total of five exposures. After a suitable rest period, the challenge exposure was performed. Before conducting the challenge test, a "SLS provocative patch test," was performed at the test site. A provocative patch test consisted of pre-treating the skin occlusively with 0.4 ml of 10% SLS on a 1.0 inch Webril square for one hour. After provocative patch test, the test chemical patches were applied under occlusive conditions on the same site for 48 hours. The challenge reactions were read immediately after removal of the 48 hours patch and again in another two days. An evident erythema was regarded as the minimum positive response. No dermal reactions were observed on the skin of the volunteers. Therefore, the test chemical was considered to be not sensitizing to humans. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
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