Registration Dossier
Registration Dossier
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EC number: 270-287-7 | CAS number: 68424-27-1 This substance is identified by SDA Substance Name: C16 and C18 unsaturated trialkyl carboxylic acid trimethylolpropane triester and SDA Reporting Number: 09-015-00.
Developmental toxicity / teratogenicity
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:
- 2 010
- 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
- Reference substance name:
- Reference substance 005
- Cas Number:
- 438836-32-2
Constituent 1
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.
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