Registration Dossier
Registration Dossier
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EC number: 300-338-1 | CAS number: 93925-36-1
Basic toxicokinetics
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:
- 2 001
- 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 substance name:
- various lactate esters
- IUPAC Name:
- various lactate esters
- Details on test material:
- ethyl lactate radiolabeled
2-ethylhexyl lactate
unspecified lactate esters
Constituent 1
- 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 / concentration:
- 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
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