Registration Dossier
Registration Dossier
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EC number: 259-217-6 | CAS number: 54549-24-5
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Test substance was not administered until one day prior to sacrifice.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 110615-47-9
- Cas Number:
- 110615-47-9
- IUPAC Name:
- 110615-47-9
- Details on test material:
- - Name of test material (as cited in study report): C12-14 Akylpolyglycosides
- Physical state: Yellowish viscous liquid
- Analytical purity: 51.1%
- Lot/batch No.: Tank 5/00016002
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- According to Guideline.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Day 6-15 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- Day 20 of gestation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 24 females
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- According to Guideline.
- Ovaries and uterine content:
- According to Guideline.
- Fetal examinations:
- According to Guideline.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- According to the study described, the test substance does not reveal any embryotoxic or teratogenic potential at dose levels up to 1000 mg/kg bw/day.
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