Registration Dossier
Registration Dossier
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EC number: 664-492-4 | CAS number: 742087-49-6
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 days in total
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Lauryl glucoside (as APG C12-C14 fatty alcohol from renewable sources, n: 1.43) was given orally, by gavage, to groups of 10 male and 10 female Sprague-Dawley rats at doses of 0, 0. l, 0.3, or I g kg/day, from 2 weeks prior to mating to 4 days after delivery.
- GLP compliance:
- not specified
- Remarks:
- Review document does not give these details.
Test material
- Reference substance name:
- Dodecyl D-glucoside
- EC Number:
- 248-685-7
- EC Name:
- Dodecyl D-glucoside
- Cas Number:
- 27836-64-2
- Molecular formula:
- C18H36O6
- IUPAC Name:
- dodecyl D-glucoside
Constituent 1
- Specific details on test material used for the study:
- Lauryl glucoside (as APG C12-C14 fatty alcohol from renewable sources, n: 1.43)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Groups of 10 male and 10 female Sprague-Dawley rats were given doses of 0, 0. l, 0.3, or I g kg/day, daily from 2 weeks prior to mating to 4 days after delivery.
- Duration of treatment / exposure:
- From 2 weeks prior to mating to 4 days after delivery.
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- Implied 10 female and male rats per dose.
- Control animals:
- yes, concurrent no treatment
Examinations
- Parental animals: Observations and examinations:
- No signs of general toxicity were observed in the parental animals
The relative and absolute weights of the testes, epididymides, and seminal vesicles were similar for treated and control animals. There were no test article-related effects on reproductive parameters.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- gross pathology
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- body weight and weight gain
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No signs of general toxicity were observed in the parental animals. The relative and absolute weights of the testes, epididymides, and seminal vesicles were similar for treated and control animals. There were no test article-related effects on reproductive parameters. The mean litter weights, mean pup weights, sex ratio, and gestation period were similar for all the groups; a slight variation in prebirth loss observed in the high-dose group 'vvas not statistically significant. There were no treatment-related effects observed for the neonates.
The NOAELs are assessed as I g/kg bw day
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