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EC number: 215-350-1 | CAS number: 1323-03-1
- 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The key information is a resultant of weight of evidence evaluation based on two sources concerning alkyl lactate esters.
Link to relevant study records
- 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-hexyl lactate ester.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 28-day aerosol inhalation study to evaluate teratogenic potential.
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure (if applicable):
- nose only
- Vehicle:
- not specified
- Details on mating procedure:
- Not specified.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 h per day
- Frequency of treatment:
- Daily for 10 days
- Details on study schedule:
- Applications on days 6–15 of gestation
- Remarks:
- Doses / Concentrations:
0, 200, or 600 mg/m3
Basis:
nominal conc. - No. of animals per sex per dose:
- 12 pregnant rats
- Control animals:
- yes
- Parental animals: Observations and examinations:
- Clinical signs, maternal body weight, organ weights and feed consumption.
- Oestrous cyclicity (parental animals):
- Yes
- 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.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- No effects on body weights, but significant reduced feed consumption at 600 mg/m3 and a slight decrease at 200 mg/m3.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- No effects on body weights, but significant reduced feed consumption at 600 mg/m3 and a slight decrease at 200 mg/m3.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- no statistically significant difference between treated and control groups in the number of corpora lutea, implants live and dead fetus, early and late resorptions, implant loss, or in sex ratio.
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/m³ air
- Based on:
- test mat.
- Remarks:
- ethyl-hexyl lactate
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- reproductive performance
- other: fertility and reproduction
- Remarks on result:
- not measured/tested
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No significant difference in sex ratio between treatment and controls.
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No diferences between treatment and control of live and dead fetus or implant loss.
- Body weight and weight changes:
- 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 specified
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 600 mg/m³ air
- Based on:
- test mat.
- Remarks:
- ethyl-hexyl lactate
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related external or visceral findings were noted. No effect on sex ratio.
- Remarks on result:
- other: Delayed ossification of the frontalis, metatarsals and hindlimb phalanges in both treatment groups, but related to stress concentrations due to the combination of nose-only exposure and respiratory tract irritation of 2-ethylhexyl-L- lactate.
- Remarks on result:
- not measured/tested
- Reproductive effects observed:
- not specified
- Conclusions:
- No significant effects were recorded on gestation of pregnant rats exposed by inhalation up to 600 mg/m3 per day. Treatment related effects were recorded on embryonal/fetal development at 200 and 600 mg/m3. However, these were considered to be indirect effects of maternal stress due to irriattion of the respiratory tract.
- 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.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Dermal developmental study
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- 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
- Remarks:
- Doses / Concentrations:
0, 517, 1551, or 3619 mg/kg
Basis:
other: applied percutaneously - No. of animals per sex per dose:
- 25 pregnant rats
- 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.
- 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: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
- 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
- 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
- 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
- Reproductive effects observed:
- not specified
- 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.
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Based on read-across and weighed evidence of studies with lactate analogues and the direct metabolites.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 200 mg/m³
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Not assignable.
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 3 619 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Not assignable.
Additional information
Justification for selection of Effect on fertility via oral route:
These studies are the most representative of the list of studies
used as weighed evidence.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on weighed evidence data of studies with analogue alkyl lactates and the direct metabolites (fatty alcohols), there is no evidence of potentially adverse effects on reproductive parameters due to exposure to the product containing both long chain alkyl lactates and fatty alcohols. Hence, there is no reason for classification as hazardous for reproduction.
Additional information
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.
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