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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:
1981
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

Constituent 1
Chemical structure
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

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)