Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 252-478-7 | CAS number: 35274-05-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study referred in a reliable review article with limited information about test methods and conditions.
- Justification for type of information:
- Information based on safety assessment of ethyl lactate.
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:
- no guideline followed
- Principles of method if other than guideline:
- Dermal developmental study
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- ethyl-L-lactate
- IUPAC Name:
- ethyl-L-lactate
- Details on test material:
- No data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
Administration / exposure
- Route of administration:
- dermal
- Duration of treatment / exposure:
- Not specified
- Frequency of treatment:
- Daily for 10 days
- Details on study schedule:
- Applications on days 6–15 of gestation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 517, 1551, or 3619 mg/kg
Basis:
other: applied percutaneously
- No. of animals per sex per dose:
- 25 pregnant rats
Examinations
- Parental animals: Observations and examinations:
- Clinical signs, maternal body weight, organ weights and feed consumption.
- Oestrous cyclicity (parental animals):
- Not specified.
- Sperm parameters (parental animals):
- Not examined.
- Litter observations:
- Not specified.
- Postmortem examinations (parental animals):
- Yes.
- Postmortem examinations (offspring):
- Yes.
- Statistics:
- Not specified.
- Reproductive indices:
- Not specified.
- Offspring viability indices:
- Yes.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No deaths; Slight erythema and desquamation
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No differences in maternal body weight.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No differences in maternal feed consumption were noted.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 3 619 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- dermal irritation
- body weight and weight gain
- food consumption and compound intake
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No effects were noted on developmental indices, gross external, soft tissue, or skeletal examination.
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 3 619 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- ethyl lactate
- Sex:
- male/female
- Basis for effect level:
- other: no data are available on dermal absorption
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No significant effects were recorded on gestation of pregnant rats exposed topically at dosages up to > 3000 mg/kg bw/day, and no effects were recorded on embryonal/fetal development.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.