Registration Dossier
Registration Dossier
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EC number: 239-268-0 | CAS number: 15214-89-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09/07/1984-16/07/1984
- 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:
- 1 984
- Report date:
- 1984
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:
- 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#63466G
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals Inc, Boyertown (PA), USA
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes (duration not specified)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3-23-9°C (65-75°F)
- Humidity (%): 45-55
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 9/07/1984 To: 16/07/1984
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 4.7
- Max. score:
- 2
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 3.3
- Max. score:
- 1
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 3.3
- Max. score:
- 2
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 2.7
- Max. score:
- 1
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 2
- Max. score:
- 1
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, ATBS was irritating to eyes.
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