Registration Dossier
Registration Dossier
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EC number: 483-990-0 | CAS number: -
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / 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 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Alkyl polyglucoside C10/C16
- IUPAC Name:
- Alkyl polyglucoside C10/C16
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Frequency of treatment:
- Daily exposure
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)
- No. of animals per sex per dose:
- 10
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Description (incidence and severity):
- No difference between treated and control animals were observed
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Results: F1 generation
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Relevant for humans:
- yes
Applicant's summary and conclusion
- Conclusions:
- The NOAEL (reproductive toxicity) for the APG-C10/C16 is 1000 mg/kg (the highest dose tested)
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