Registration Dossier
Registration Dossier
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EC number: 204-265-5 | CAS number: 118-61-6
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Closed Epicutaneous Test
- Author:
- M. ISHIHARA et al.
- Year:
- 1 986
- Bibliographic source:
- Hifu 28: 230–240
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethyl salicylate
- EC Number:
- 204-265-5
- EC Name:
- Ethyl salicylate
- Cas Number:
- 118-61-6
- Molecular formula:
- C9H10O3
- IUPAC Name:
- ethyl 2-hydroxybenzoate
- Test material form:
- liquid
Constituent 1
Method
- Type of population:
- general
- not specified
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 25
- Clinical history:
- not specified
- Route of administration:
- dermal
- Details on study design:
- Induction phase:
- patches applied using 12% of test item
Challenge phase:
- a challenge patch was applied with 12 % of test item
Results and discussion
- Results of examinations:
- Observations remained negative throughout the test interval.
Applicant's summary and conclusion
- Conclusions:
- Under the condtions of the study, the test material indicated no potential for dermal irritation or allergic sensitization.
- Executive summary:
The cutaneous sensitization potential of the test item has been assessed using maximization test in human, which was developed by Klingman and modified by Klingman and Epstein. 25 subjects received 12% (induction and challenge phase). The test material indicated no potential for dermal irritation or allergic sensitization.
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