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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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)