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Toxicological information

Sensitisation data (human)

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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:
1986
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

Constituent 1
Chemical structure
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%

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.