Registration Dossier
Registration Dossier
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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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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