Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 239-268-0 | CAS number: 15214-89-8
Toxicological information
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02/02/1996-16/02/1996
- 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:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
- IUPAC Name:
- 2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
- Reference substance name:
- Ammonium 2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonate
- EC Number:
- 421-680-9
- EC Name:
- Ammonium 2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonate
- IUPAC Name:
- 421-680-9
- Reference substance name:
- 58374-69-9
- EC Number:
- 611-646-3
- Cas Number:
- 58374-69-9
- IUPAC Name:
- 58374-69-9
- Details on test material:
- - Name of test material (as cited in study report): OS 114454
- Molecular formula (if other than submission substance): C7H16N2O4S
- Molecular weight (if other than submission substance): 225.29
- Smiles notation (if other than submission substance): [NH4+].O=S(=O)(O)CC(C)(C)/N=C(\[O-])C=C
- InChl (if other than submission substance): 1/C7H13NO4S.H3N/c1-4-6(9)8-7(2,3)5-13(10,11)12;/h4H,1,5H2,2-3H3,(H,8,9)(H,10,11,12);1H3
- Substance type: organic
- Physical state: liquid
- 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: not specified
- Storage condition of test material: original container at room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products Inc, Denver (PA), USA
- Age at study initiation: Young adult
- Weight at study initiation: 2164- 2512 grams
- Fasting period before study:
- Housing: Individual suspended mesh bottom cages
- Diet: ad libitum)
- Water: ad libitum)
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-20.2°C (67.5-68.4°F)
- Humidity (%): 34.1-54.1%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2/2/1996 To: 16/2/1996
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal skin
- % coverage: approximately 23
- Type of wrap if used: gauze binder with collar
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with deionised water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.45 ml/kg
- Concentration (if solution): 50%
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 4,000 mg/kg test material (2,000 mg/kg active ingredient)
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily post-administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 4 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were observed.
- Clinical signs:
- other: Two rabbits had instances of soft stool on days 1 and 6, but this finding was determined not to be related to the test material. There were no other clinical findings. The test material induced very slight to slight erythema on all animals. Three rabbits
- Gross pathology:
- Upon terminal necropsy, two rabbits displayed accessory splenic tissue, a common congenital abnormality in New -Zealand white rabbits. Dark red lungs were noted in two animals. There were no other remarkable finding.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test substance (OS 114454) was found to be greater than 2000 mg/kg (based on active ingredient, 4000 mg/kg based on test substance) when administered once for 24 hours to the clipped, intact skin of male and female albino rabbits. In addition, 2000 mg/kg (based on active ingredient, 4000 mg/kg based on test substance) was found to be a No-Observable-Effect Level (NOEL) for systemic toxicity under the conditions of this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
