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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Secondary source is a report on lactate esters prepared by the Council’s Dutch Expert Committee on Occupational Standards in co-operation with the Swedish Criteria Group, which advises the Swedish government. The committee’s conclusions are based on scientific publications obtained from data retrieval systems prior to December 1998 and checked with results of scientific publications between 1998 and 2000.

Data source

Reference
Reference Type:
secondary source
Title:
Lactate esters: Health-based recommended occupational exposure limit
Author:
Council’s Dutch Expert Committee on Occupational Standards (DECOS)
Year:
2001
Bibliographic source:
No. 2001/04OSH, The Hague, 6 December 2001; ISBN: 90-5549-396-1

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
Principles of method if other than guideline:
Methods are not specified to the level of method or guidelines followed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
ethyl lactate radiolabeled
2-ethylhexyl lactate
unspecified lactate esters
Radiolabelling:
yes
Remarks:
Test with ethyl lactate

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: dermal, oral or in-vitro
Vehicle:
not specified
Duration and frequency of treatment / exposure:
Test with dermal exposure to radiolabeled ethyl lactate: 24 h exposure
Doses / concentrations
Remarks:
Doses / Concentrations:
Not specified
No. of animals per sex per dose:
Not specified
Control animals:
not specified

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
Lactate esters are partial absorbed before hydrolysis in both skin after dermal or blood after oral exposure.
Type:
distribution
Results:
Topical applied radiolabeled ethyl lactate, present on skin of rats for up to 24 hours, was traced in all parts of the skin. No test results are available for distribution of lactate esters in other organs or tissues after oral or dermal absorption .
Type:
metabolism
Results:
After oral administration or topical application, lactate esters are enzymatically hydrolysed in lactic acid and an alcohol. Hydrolysis occurs in various rat tissue homogenates (e.g. plasma, nasal epithelium, liver, skin, intestinal mucosa and the cecum).
Type:
excretion
Results:
There are no quantitative data on clearance and elimination of lactate esters, but the relative rapid hydrolysis indicates that elimination pathways are expected mimic those for lactic acid and alcohols.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
lactic acid and alcohols

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results