Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 444-850-4 | CAS number: 1235390-87-0
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Investigations on the effects of alkyl polyglucosides on development and fertility
- Author:
- H. Messinger, W. Aulmann, M. Kleber, W. Koehl
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- CD-1
Administration / exposure
- Route of administration:
- oral: gavage
- Frequency of treatment:
- Daily exposure between day 6 and day 15 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Description (incidence and severity):
- all females had viable foetuses (with or without treatment) and pre- and post-implantation loss as well as numbers of resorption were not affected by treatment whatever the doses
- Description (incidence and severity):
- No lethality was observed on all pups
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- dead fetuses
- number of abortions
- total litter losses by resorption
Results (fetuses)
- Description (incidence and severity):
- skeletal and visceral examinations did not show malformations
- Description (incidence and severity):
- skeletal and visceral examinations did not show malformations
- Description (incidence and severity):
- skeletal and visceral examinations did not show malformations
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- skeletal malformations
- visceral malformations
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Relevant for humans:
- yes
Applicant's summary and conclusion
- Conclusions:
- The NOAEL (developmental toxicity) for the APG-C12/C16 is 1000 mg/kg (the highest dose tested)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
