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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1996
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

Constituent 1
Reference substance name:
ethyl lactate, n-butyl lactate and propyl-L-lactate
IUPAC Name:
ethyl lactate, n-butyl lactate and propyl-L-lactate

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