Registration Dossier
Registration Dossier
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EC number: 203-745-1 | CAS number: 110-19-0
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature (review)
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
- Reference Type:
- other: type unknown
- Title:
- No information
- Author:
- Epstein WL
- Year:
- 1 976
- Bibliographic source:
- Report to RIFM, 27 August; cited in Opdyke (1978)
- Report date:
- 1976
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Maximization test according to Kligman and Epstein (1975, reference 3)
- GLP compliance:
- no
Test material
- Reference substance name:
- Isobutyl acetate
- EC Number:
- 203-745-1
- EC Name:
- Isobutyl acetate
- Cas Number:
- 110-19-0
- Molecular formula:
- C6H12O2
- IUPAC Name:
- isobutyl acetate
- Details on test material:
- - Name of test material (as cited in study report): isobutyl acetate
- no further information on test substance
Constituent 1
Method
- Type of population:
- not specified
- Subjects:
- - Number of subjects exposed: 28
- Sex: no data
- no further details - Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- - concentration: 2% test substance in petrolatum
Results and discussion
- Results of examinations:
- No sensitization reaction was produced by the test substance (2% in petrolatum) in the test system used.
Applicant's summary and conclusion
- Conclusions:
- In a maximization test according to Kligman (Kligman and Epstein 1975) on 28 human volunteers, using a 2% isobutyl acetate solution in petrolatum, no skin sensitization reaction was produced.
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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