Registration Dossier
Registration Dossier
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EC number: 280-518-3 | CAS number: 83682-78-4
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 28 days
- 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 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Remarks:
- Assumed GLP - EPA considers valid study
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:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Salivation
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Signs of irritation to GI rtract in highest dose
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Other than local effects to GI tract in thehighest dose levels, no other adverse effects were reported in the review document.
Applicant's summary and conclusion
- Conclusions:
- Although the EPA review is brief and the primary data source is unknown, the EPA consider the result valid.
There appears to be no specifc target organ
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.
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