Registration Dossier
Registration Dossier
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EC number: 280-518-3 | CAS number: 83682-78-4
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Administration on gestation days 5 - 19 (14 day period)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Information taken from US EPA review of surrogate substance
Considered reliable by EPA, although primary source not known.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Administration by gavage on days 5 - 19 of gestation in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
- EC Number:
- 263-058-8
- EC Name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
- Cas Number:
- 61789-40-0
- Molecular formula:
- C19H38N2O3
- IUPAC Name:
- {[3-(Dodecanoylamino)propyl](dimethyl)ammonio}acetate
Constituent 1
- Specific details on test material used for the study:
- The test material is a betaine formed by hydrolysis of the phosphate ester
A justification for read-across is attached.
Test animals
- Species:
- rat
- Strain:
- CD-1
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Treatment from day 5 - day 19 of gestation
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 95 mg/kg bw/day (nominal)
- Dose / conc.:
- 286 mg/kg bw/day (nominal)
- Dose / conc.:
- 950 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 21 females
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At top dose level, one animal died and others showed reduced body weights and damage to GI tract.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- One death in top group; assumed treatment related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced body weight top dose
Maternal developmental toxicity
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- Resoprtions seen at highest dose levels
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 95 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 286 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
The reduced litter sizes due to resorptions considered to be related to maternal toxicity effects
Applicant's summary and conclusion
- Conclusions:
- The betaine was tested at up to tolerated treatment levels with reduction in live pups directly related to maternal toxicity.
There were no developmental effects.
Although there is little detail in the reivew document, the EPA considered the data valid in their assessment that there is no apparent developmental toxicity.
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