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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
Not relevant
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Ethyl lactate is rapidly hydrolysed into lactic acid and ethanol in vivo.

Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.

In extremis, ethanol can elicit adverse effects on the reproductive system and on fertility and fecundability in males and females and can trigger developmental toxicity in females. However, it is clear that this occurs at Body Ethanol Levels that can only be achieved by deliberate oral consumption of alcoholic beverages. In the context of potential exposure resulting from occupational or consumer use of ethyl lactate resulting ethanol exposure appears unlikely to present human health hazards.

Therefore, submitting a reprotox study is not relevant.


Short description of key information:
Ethyl-S-lactate is rapidly hydrolysed into lactic acid and ethanol in vivo.
Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.
In extremis, ethanol can elicit adverse effects on the reproductive system and on fertility and fecundability in males and females and can trigger developmental toxicity in females. However, it is clear that this occurs at Body Ethanol Levels that can only be achieved by deliberate oral consumption of alcoholic beverages. In the context of potential exposure resulting from occupational or consumer use of ethyl lactate resulting ethanol exposure appears unlikely to present human health hazards.
Therefore, submitting a reprotox study is not relevant.

Effects on developmental toxicity

Description of key information
Ethyl lactate is rapidly hydrolysed into lactic acid and ethanol in vivo.
Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.
In extremis, ethanol can elicit adverse effects on the reproductive system and on fertility and fecundability in males and females and can trigger developmental toxicity in females. However, it is clear that this occurs at Body Ethanol Levels that can only be achieved by deliberate oral consumption of alcoholic beverages. In the context of potential exposure resulting from occupational or consumer use of ethyl lactate resulting ethanol exposure appears unlikely to present human health hazards.
Therefore, submitting a developmental toxicity study is not relevant.
Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, but older study and only part of report available
Qualifier:
according to
Guideline:
other: EPA, Washington, D.C. Federal Register. Friday. September 27, 1985. Vol. 50 No. 188, 40 CFR Part 798 Part 4900. Toxic Substance Control Act Test Guidelines: Final Rules.
Deviations:
no
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
other: Crl:CD®(SD)BR Presumed Pregnant Rats
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 bandag (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): wiped with water
- Time after start of exposure:6 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): sham, 0.517, 1.551 and 3.619 g/kg/day
- Concentration (if solution):pure
- Constant volume or concentration used: no



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:
Ethyl lactate was applied percutaneously to the rats once daily for a six-hour exposure period on days 6 through 15 of gestation.
Frequency of treatment:
Ethyl lactate was applied percutaneously to the rats once daily for a six-hour exposure period on days 6 through 15 of gestation.
Remarks:
Doses / Concentrations:
0 g/kg/day
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
0.517 g/kg/day
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
1.551 g/kg/day
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
3.619 g/kg/day
Basis:
nominal conc.
No. of animals per sex per dose:
25 presumed pregnant rats/group
Control animals:
yes, sham-exposed
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 insitu. Each rat was observed aily during teh 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.

One low dosage group dam was inadvertently sacrificed on day 18 of gestation. All other dams were sacrificed and necropsied on day 20 of presumed gestation. Maternal tissues with gross lesions present wer retainde 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.
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).
Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
The highest dosage (3.619 g/kg/day) caused slight erythema and/or desquamation more frequently than these signs occurred in sham control group rats. These skin observations may have been interrelated with incidental hyperactivity that occurred for one high dosage group rat. The incidences of thes skin and clinical observations were not statistically significant,as compared with the sham control group value.
Dose descriptor:
NOAEL
Effect level:
> 1 551 - < 3 619 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
> 3 619 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: developmental toxicity
Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No adverse effects on embryo-fetal viability, body weight or morphology were observed.
Abnormalities:
not specified
Developmental effects observed:
not specified
Conclusions:
Ethyl lactate is minimally toxic to pregnant rats at the highest dosage that could be tested (3.619 g/kg/day) and at this maximum dosage is not a developmental toxicant.
Executive summary:

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, 0.517, 1.551 and 3.619 g/kg/day from days 6 through 15 of gestation.

Percutaneously application of ethyl lactate to pregnant rats at the highest The highest dosage that could be given (3.619 g/kg/day) caused slight erythema and/or desquamation more frequently than these signs occurred in sham control group rats. These skin observations may have been interrelated with incidental hyperactivity that occurred for one high dosage group rat. The incidences of thes skin and clinical observations were not statistically significant,as compared with the sham control group value. The maternal LOAEL is 3.619 g/kg/day, based on slight erythema and/or desquamation. The maternal NOAEL is > 1.551 and < 3.619.

No adverse effects on embryo-fetal viability, body weight or morphology were observed. The developmental NOAEL is 3.619 g/kg/day.

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 adverse effect observed
Dose descriptor:
NOAEL
3 619 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Ethyl lactate is minimally toxic to pregnant rats at the highest dosage that could be tested (3.619 g/kg/day) and at this maximum dosage is not a developmental toxicant. GLP study, but older study and only part of report available.
Additional information

Ethyl lactate is rapidly hydrolysed into lactic acid and ethanol in vivo.

Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.

In extremis, ethanol can elicit adverse effects on the reproductive system and on fertility and fecundability in males and females and can trigger developmental toxicity in females. However, it is clear that this occurs at Body Ethanol Levels that can only be achieved by deliberate oral consumption of alcoholic beverages. In the context of potential exposure resulting from occupational or consumer use of ethyl lactate resulting ethanol exposure appears unlikely to present human health hazards.

Therefore, submitting a developmental toxicity study is not relevant.

However, a developmental toxicity study was performed in which ethyl lactate was administered to 25 female Crl:CD®(SD)BR presumed pregnant rats/dose applied percutaneously at dose levels of 0, 0.517, 1.551 and 3.619 g/kg/day from days 6 through 15of gestation. No adverse effects on embryo-fetal viability, body weight or morphology were observed. The developmental NOAEL is 3.619 g/kg/day.

Justification for classification or non-classification

Ethyl lactate is rapidly hydrolysed into lactic acid and ethanol in vivo.

Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.

In extremis, ethanol can elicit adverse effects on the reproductive system and on fertility and fecundability in males and females and can trigger developmental toxicity in females. However, it is clear that this occurs at Body Ethanol Levels that can only be achieved by deliberate oral consumption of alcoholic beverages. In the context of potential exposure resulting from occupational or consumer use of ethyl lactate resulting ethanol exposure appears unlikely to present human health hazards.

Therefore, no classification for effects on fertility and developmental toxicity/teratogeniticy is required.