Registration Dossier
Registration Dossier
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EC number: 407-770-0 | CAS number: 61597-96-4 D(+)-LACTATE D'ISOBUTYLE
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Published review article. Ethyl lactate used as read-across partner.
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Special Issue VI: Monographs on Fragrance Raw Materials
- Author:
- Opdyke, DLJ & Letizia, C (Eds.)
- Year:
- 1 982
- Bibliographic source:
- Food and Chemical Toxicology Volume 20: 677-678
- Reference Type:
- publication
- Title:
- Safety Assessment of Lactate Esters
- Author:
- Clary JJ, Feron VJ and van Velthuijsen JA
- Year:
- 1 998
- Bibliographic source:
- Regulatory Toxicology and Pharmacology 27: 88-97
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: maximization test
- Deviations:
- not specified
- Principles of method if other than guideline:
- A maximization test (Kligman 1966) was carried out.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethyl lactate
- EC Number:
- 202-598-0
- EC Name:
- Ethyl lactate
- Cas Number:
- 97-64-3
- IUPAC Name:
- ethyl 2-hydroxypropanoate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Ethyl lactate
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- N.A.
- Clinical history:
- N.A.
- Controls:
- N.A.
- Route of administration:
- dermal
- Details on study design:
- A maximization test (Kligman 1966) was carried out on 25 volunteers. The material was tested at concentration of 8 % in petrolatum
Results and discussion
- Results of examinations:
- No sensitisation occurred.
Applicant's summary and conclusion
- Conclusions:
- A maximization test (Kligman 1966) was carried out on 25 volunteers. The test item was tested at a concentration of 8 % in petrolatum and produced no sensitisation reactions.
- Executive summary:
In the publication by Opdyke et al. (1982) the results of a study performed by Kligman (1976) were referenced. Kligman conducted a maximisation test (Kligman 1966) on 25 human volunteers. The test item ethyl lactate was tested at a concentration of 8 % in petrolatum and produced no sensitisation reactions. By way of read-across, this may be considered as an indicatition that lactate esters in general, including isobutyl-R-lactate, do not entail a skin sensitisation hazard.
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