Registration Dossier
Registration Dossier
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EC number: 225-948-4 | CAS number: 5165-97-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented report of a guideline study conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium 2-methyl-2-[(1-oxoallyl)amino]propanesulphonate
- EC Number:
- 225-948-4
- EC Name:
- Sodium 2-methyl-2-[(1-oxoallyl)amino]propanesulphonate
- Cas Number:
- 5165-97-9
- Molecular formula:
- C7H13NO4S.Na
- IUPAC Name:
- sodium 2-(acryloylamino)-2-methylpropane-1-sulfonate
- Details on test material:
- - Name of test material: OS#48933E
- Substance type: organic
- Analytical purity: 50% aqueous solution
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: between 200 and 300 mg
- Fasting period before study: deprived of food but not water overnight prior to dosing.
- Diet: ad libitum during observation period
- Water: ad libitum during observation period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% weight/volume suspension in water - Doses:
- 500, 1000, 2000, 4000, and 8000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- 16 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities.
- Clinical signs:
- other: No unusual clinical or behavioural signs were observed in animals receiving dosages ranging from 1000-8000 mg/kg. Animals receiving 16000 mg/kg appeared ruffled and lethargic within 3-4 hours of test material administration. All animals appeared normal by
- Gross pathology:
- No remarkable gross pathological findings were observed.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were no effects in the rat at the highest dose of 16000 mg/kg. This is considered to be the No Observed Adverse Effect Level (NOAEL)
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