Registration Dossier
Registration Dossier
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EC number: 225-948-4 | CAS number: 5165-97-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 20-27, 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:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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 (as cited in study report): OS#48933E
- Physical state: liquid
- Analytical purity: >99%
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: young adult
- Weight at study initiation: not specified
- Housing: individual cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21.2 (68-72°F)
- Humidity (%): 45-50
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20/10/1981 To: 27/10/1981
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: 50% (undiluted) - Duration of treatment / exposure:
- Single application (unwashed)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 2, 3, 4 and 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 2, 3, 4 and 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 2, 3, 4 and 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Moderate conjuctival irritation was apparent in the dosed eyes of all 6 rabbits. All rabbits had a normal ocular appearance within 72 hours to 4 days.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was considered to be not irritating to eyes under the test conditions.
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