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EC number: 204-658-1 | CAS number: 123-86-4
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- year of publication: 1986
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: insufficiently documented literature data (e.g. no individual results, no information on study population, challenge concentration not given)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated insult human patch test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-butyl acetate
- EC Number:
- 204-658-1
- EC Name:
- N-butyl acetate
- Cas Number:
- 123-86-4
- Molecular formula:
- C6H12O2
- IUPAC Name:
- butyl acetate
- Details on test material:
- - Name of test material (as cited in study report): n-butyl acetate
- purity: at least 98%
Constituent 1
Method
- Type of population:
- not specified
- Subjects:
- 50
- Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- INDUCTION:
- nine 24 h applications of 0.2 mL over a 3-week period
- concentration: 100%
CHALLENGE:
- 10 to 14 days after the final induction
- concentration: 100%
Results and discussion
- Results of examinations:
- OTHER RESULTS: None (0%) of the participants were sensitised.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions in this study n-Butyl acetate was not sensitising to humans.
- Executive summary:
A repeated insult patch test has been performed with 50 humans (nine 24-hour applications with 0.2 ml of the test substance over three weeks; challenge 10 to 14 days after the final induction application). None of the participants showed a sensitising reaction to n-butyl acetate (Gad et al., 1986).
The study has been judged not to be reliable (RL3), due to insufficient description of the study design and the results.
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