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EC number: 211-694-1 | CAS number: 687-47-8
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988 to 1989-09-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- 1985
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl lactate
- EC Number:
- 202-598-0
- EC Name:
- Ethyl lactate
- Cas Number:
- 97-64-3
- IUPAC Name:
- ethyl 2-hydroxypropanoate
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material used in the report: Ethyl lactate
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test substance Ethyl lactate was supplied by the sponsor and applied "neat". All doage calculations were based on 100% purity and activity.
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)BR
- Details on test animals or test system and environmental conditions:
- not further specified
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: 7 x 5 cm
- Type of wrap if used: an aluminium foil patch (covering at least the shaved dorsal area of dosage application) that will be held in place by a medical-type adhesive bandage (e.g. Poroplast®).
- Time intervals for shavings or clipplings: Shaving will be repeated as necessary throughout the dosage period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After completion of the approximately six-hour exposure period/day the bandage and dressing were removed and the application site was wiped with clean water.
- Time after start of exposure: 6 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): sham, 517, 1551 and 3619 mg/kg bw/day
USE OF RESTRAINERS FOR PREVENTING INGESTION: Each rat was fitted with an Elizabethan collar. - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- There were 25 presumed pregnant rats in each group.
- Duration of treatment / exposure:
- Between gestation day 6 and gestation day 15
- Frequency of treatment:
- Daily between gestation day 6 and 15
- Duration of test:
- On gestation day 20 all animals were sacrificed
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control group
- Dose / conc.:
- 517 mg/kg bw/day (nominal)
- Remarks:
- Low dose group
- Dose / conc.:
- 1 551 mg/kg bw/day (nominal)
- Remarks:
- Mid dose group
- Dose / conc.:
- 3 619 mg/kg bw/day (nominal)
- Remarks:
- High dose group
- No. of animals per sex per dose:
- 25 presumed pregnant female rats/group
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: The high dosage was selected because it was the maximum volume of Ethyl lactate that could be applied to a surface area of approximately 35 cm² on each rat's back.
Examinations
- Maternal examinations:
- Day 0 of presumed gestation was defined as the day spermatozoa were identified in a smear of the vaginal contents or a copulatory plug was found in situ. Each rat was observed daily during the dosage and postdosage periods for evidence of skin reactions and other clinical signs of test substance effects, including: death, abortion, premature delivery, body weight and feed consumption.
All dams were sacrificed and necropsied on day 20 of presumed gestation. Maternal tissues with gross lesions present were retained in neutral bufferd 10% formalin. The liver of each dam was weighed. - Ovaries and uterine content:
- The uterine contents were examined for implantations, early and late resoprtions, and live and dead fetuses. Corpora lutea were counted for each ovary.
- Blood sampling:
- Not determined
- Fetal examinations:
- Fetuses were evaluated for viability, body weight, sex and gross external morphology. Approximately one-half of the fetuses in each litter were fixed in Bouin's solution prior to visceral evaluation (Wilson's sectioning). The remaining fetuses in each litter wer eviscerated, fixed in alcohol and processed for skeletal evlutation (alizarin red S staining).
- Statistics:
- A statistical analysis was conducted (averages, standard deviations and significance)
- Indices:
- Number of corpora lutea, implantation sites, early and late resorptions, number of live and dead foetuses, sex ratio,fetal body weights and percentage of dead or resorbed conceptuses.
- Historical control data:
- Not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- see box "Details on results"
- Dermal irritation (if dermal study):
- effects observed, treatment-related
- Description (incidence and severity):
- see box "Details on results"
- Mortality:
- no mortality observed
- Description (incidence):
- see box "Details on results"
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Other effects:
- not examined
- Details on maternal toxic effects:
- No deaths occurred during this study. Of 25 animals assigned to each group, pregnancy occurred in 25, 24, 23 and 25 rats in the 0 (Sham), 517, 1551 and 3619 mg/kg bw/day dosage groups, respectively.
One low dosage group rat was inadvertently sacrificed on day 18 of gestation, reducing the number of low dosage group rats with day 20 of gestation litters from 24 to 23. The high dosage of Ethyl lactate resulted in a biologically important increase (not statistically significant) in the number of rats with slight (grade 1) erythema and slight (grade 1) desquamation, as compared with the sham control group number. These minimal signs of irritation or dehydration generally did not occur until the last one or two days of the dosage period and sometimes persisted until day 20 of gestation. Hyperactivity occurred on two days for one high dosage group rat; this clinical sign may have been interrelated with the minimal erythema and desquamation that also occurred for this rat.
No other skin reactions or clinical observations and no necropsy observations were considered effects of percutaneous administration of the test substance to the dams at dosages as high as 3619 mg/kg bw/day.
There were no dosage-dependent or statistically significant differences in average maternal body weight gains during the dosage period (calculated as days 6 to 16 of gestation). Similar average maternal body weight changes also occurred for the dams in the four dosage groups during the postdosage period.
Average maternal liver weights and liver weight/terminal body weight ratios (%) were unaffected by percutaneous administration of the test substance at dosages as high as 3619 mg/kg bw/day.
There were no biologically important or statistically significant differences in the absolute (g/day) or relative (g/kg/day) maternal feed consumption values during the dosage period (the entire dosage period is calculated as days 6 to 16 of gestation). Similarly, while slightly decreased for the high dosage group rats during the postdosage period (days 16 to 20 of gestation), there were no biologically important or statistically significant differences in absolute or relative maternal feed consumption average values for the four groups.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- maternal toxicity
- Effect level:
- 1 551 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: see Remarks
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Effect level:
- 3 619 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse effects observed
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Changes in litter size and weights:
- not examined
- Anogenital distance of all rodent fetuses:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- see box "Details on results"
- Other effects:
- not examined
- Details on embryotoxic / teratogenic effects:
- No observation made at Caesarean-sectioning of the dams was attributed to the test substance. Average values for corpora lutea, implantations, litter sizes, live and dead fetuses, and early and late resorptions were comparable in the four dosage groups. Similarly, the averages for fetal sex ratios, body weights and percentage of dead or resorbed conceptuses per litter were biologically comparable among the four groups. There were no statistically significant differences.
Gross external, soft tissue and skeletal examinations of the fetuses did not reveal any malformations or variations that were considered effects of the test substance.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 3 619 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In a developmental toxicity study, ethyl lactate was administered to 25 female Crl:CD®(SD)BR presumed pregnant rats /dose applied percutaneously at dose levels of 0, 517, 1551 and 3619 mg/kg bw/day from days 6 through 15 of gestation. Based on the results, the maternal NOAEL is 1551 mg/kg bw/day and the NOAEL for developmental toxicity is 3619 mg/kg bw/day.
- Executive summary:
In a developmental toxicity study conducted according to EPA OTS 798.4000, ethyl lactate was administered for six hours/day to 25 female Crl:CD®(SD)BR presumed pregnant rats/dose group percutaneously under occlusive conditions at levels of 0, 517, 1551 and 3619 mg/kg bw/day from day 6 through 15 of gestation. On day 20 of gestation the animals were sacrificed.
Dermal application of ethyl lactate to pregnant rats at the highest dose that could be given (3619 mg/kg bw/day) caused slight erythema and/or desquamation more frequently in comparison to the control group. Hyperactivity occurred on two days for one rat from the high dose group, which is probably related to the slight erythema and desquamation that also occurred for this rat. No other skin reactions or clinical observations and no adverse necropsy findings were observed in the animals. There were no treatment-related effects on mortality, body weight, food consumption and caesarean parameters. Gross external, soft tissue and skeletal examinations of fetuses did not reveal any malformations or variations that were considered adverse.
It is concluded that percutaneous application of ethyl lactate to pregnant rats was minimally toxic to the dams at the highest dosage that could be tested (3619 mg/kg bw/day), and that this maximum dosage did not result in developmental toxicity. Based on the results, the maternal NOAEL is considered to be 1551 mg/kg bw/day, and the developmental NOAEL is considered to be 3619 mg/kg bw/day.
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