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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:
migrated 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.

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

Reference
Name:
Unnamed
Type:
Constituent
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.