Registration Dossier

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 shorter chain alkyl lactates.See section 13 for justification of read across.

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:
1996
Bibliographic source:
Regulatory Toxicology & Pharmacology 27, 88–97 (1998); Article No. Rt971175

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent

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