Registration Dossier
Registration Dossier
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EC number: 908-918-1 | CAS number: -
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- substance was allowed to volatize from the patch for 15min prior to application. Potentially hardly any test substance applied.
Data source
Reference
- Reference Type:
- publication
- Title:
- Submission of unpublished data by CTFA. Repeat insult patch test on amyl and Isoamyl Acetate
- Author:
- CTFA
- Year:
- 1 987
- Bibliographic source:
- cited in: Ibanez, P., Final Report on the Safety Assessment of Amyl Acetate and Isoamyl Acetate, J. Americ. Coll. Toxicol., 7(6), 705-719, 1988
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeat insult patch test with 197 subjects.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reference substance 001
- Details on test material:
- no data
Constituent 1
Method
- Type of population:
- not specified
- Subjects:
- - Number of subjects exposed:
- Sex: 211 male and female subjects, a total of 197 subjects completed the study
- Other: - Controls:
- A vehicle control, 75% ethanol and 25% diethyl phthalate, was also included in the testing program.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Description of patch: The test material, 0 .3 ml, was applied to a Webril patch and allowed to volatilize for 15 minutes before applying the patch to the skin site.
- Concentrations: 20% solution
- Volume applied: 0.3 ml
- Testing/scoring schedule: The sites were evaluated at 48 and 96 h after application throughout the treatment period.Following a 10-15 day nontreatment period, the subjects were given a challenge patch using the same dose and contact period as used during the induction phase of the study.
- Removal of test substance: after 24 h (the sites were evaluated and fresh patches applied three times per week for 3 weeks)
Results and discussion
- Results of examinations:
- No evidence of delayed-contact hypersensitivity was observed, and no adverse reactions were observed during the entire exposure period to amyl acetate.
Applicant's summary and conclusion
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