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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guidance on registration Reference: ECHA-16-G-06-EN Publ.date:November 2016
Read-Across Assessment Framework (RAAF) Reference: ECHA-15-R-07-EN Date: May 2015
Practical guide 2: How to report weight of evidence - Reference: ECHA-10-B-05-EN Publ.date: 24/03/2010

Data source

Reference
Reference Type:
publication
Title:
Hazard Characterization Document - Polyol esters category
Author:
US Environmental Protection Agency
Year:
2010
Bibliographic source:
US EPA

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: European Communities L133, Methods for Determination of Toxicity, "Teratogenicity" (Annex V, adopted November 18, 1987)

Test material

Constituent 1
Reference substance name:
Reference substance 006
Cas Number:
438836-32-2

Test animals

Species:
rat
Strain:
other: Crl:CD BR vaf/plus rats

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Frequency of treatment:
Daily on each gestation days 6-15
Duration of test:
10 days

Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Dose / conc.:
100 mg/kg bw/day
Dose / conc.:
500 mg/kg bw/day
Dose / conc.:
1 000 mg/kg bw/day
No. of animals per sex per dose:
25/group
Control animals:
yes

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
clinical signs
Remarks on result:
other: highest dose tested

Results (fetuses)

Fetal body weight changes:
no effects observed
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Changes in sex ratio:
no effects observed
External malformations:
no effects observed

Effect levels (fetuses)

Key result
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
changes in sex ratio
fetal/pup body weight changes
external malformations

Overall developmental toxicity

Key result
Developmental effects observed:
no

Applicant's summary and conclusion

Conclusions:
There was no evidence of maternal toxicity observed at any dose level tested. There
were no statistically significant differences in mean body weight, body weight change,
uterine weight, corrected body weight, food consumption, or uterine implantation data
Between treated and control animals. Additionally, there was no mortality or adverse
clinical/postmortem signs which were considered treatment-related. In the fetuses, there
was no evidence of growth retardation or increased fetal death in the treated groups
compared with controls. Additionally, there were no biologically significant differences
in total or individual variations or malformations (external, visceral, or skeletal) in the
treated groups when compared with controls on either a per fetus or per litter basis. Thtest material
was not considered embryotoxic nor teratogenic under the conditions of this study.