Registration Dossier
Registration Dossier
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EC number: 239-268-0 | CAS number: 15214-89-8
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:
- according 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:
- 2-acrylamido-2-methylpropanesulphonic acid
- EC Number:
- 239-268-0
- EC Name:
- 2-acrylamido-2-methylpropanesulphonic acid
- Cas Number:
- 15214-89-8
- Molecular formula:
- C7H13NO4S
- IUPAC Name:
- (1Z)-N-(2-methyl-1-sulfopropan-2-yl)prop-2-enimidic acid
- Details on test material:
- - Name of test material: OS#61349
- Substance type: organic
- Physical state: solid
- Analytical purity: not specified
- 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:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 200-300 g
- Fasting period before study: yes (but not water)
- Housing: not specified
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: 12/03/1981 To: 01/04/1981
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% weigh/volume suspension in water
VEHICLE
- Concentration in vehicle: 500 mg/ml
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: water soluble test substance
- Lot/batch no. (if required): not specified
- Purity: not specified
MAXIMUM DOSE VOLUME APPLIED: 4 ml - 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
- Frequency of observations and weighing: periodicity not specified
- Necropsy of survivors performed: no
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 830 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 990 - 3 390
- Mortality:
- At 500mg/kg: no deaths were observed.
At 1000 mg/kg: deaths occurred in 2 animals after 4 hours. These animals remained moribund for the next 2-3 days during which time an additional death occurred.
At 2000 mg/kg: 3 animals died 3 hours after dosing.
At 4000 mg/kg: 2 animals died after 3 hours. The remaining animals were semi-comatose for the next 72 hours, with an additional 2 animals expiring on days 3 and 4.
At 8000 mg/kg : all animals died within 15 minutes. - Clinical signs:
- other: At the lowest dose tested, the animals were lethargic and ruffled after 2 hours. Their condition appeared essentially unchanged after 24 hours. The rats appeared normal within 48 hours. No unscheduled deaths occurred in this group. Animals receiving 1000
- Gross pathology:
- No remarkable gross pathological findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of ATBS at 14 days in the rat was calculated to be 1830 mg/kg bw (Confidence limits = 990-3900).
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