Registration Dossier
Registration Dossier
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EC number: 947-574-7 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Original tests performed according to an international guideline under GLP.
- Justification for type of information:
- Data originate from testing with smaller chain alkyl lactates.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Safety Assessment of Lactate Esters
- Author:
- Clary J J, Feron V J and van Velthuijsen J A
- Year:
- 1 996
- Bibliographic source:
- Regulatory Toxicology & Pharmacology 27, 88–97 (1998); Article No. Rt971175
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- tests with n-propyl lactate
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- tests with n-propyl lactate
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- ethyl lactate, n-butyl lactate and propyl-L-lactate
- IUPAC Name:
- ethyl lactate, n-butyl lactate and propyl-L-lactate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- not specified
- Duration of exposure:
- Not specified
- Doses:
- ethyl lactate and n-butyl lactate: 5000 mg/kg
propyl-L-lactate: 2000 mg/kg - No. of animals per sex per dose:
- Not specified.
- Control animals:
- not specified
Results and discussion
Effect levelsopen allclose all
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- ethyl lactate
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- n-butyl lactate
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- propyl-L-lactate
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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