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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

Toxicological information

Toxicity to reproduction

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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:
1996
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

Constituent 1
Reference substance name:
ethyl-L-lactate
IUPAC Name:
ethyl-L-lactate
Details on test material:
No data

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)

No effects were noted on developmental indices, gross external, soft tissue, or skeletal examination.

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.