Registration Dossier
Registration Dossier
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EC number: 201-058-1 | CAS number: 77-78-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally acceptad scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 0.05 ml of the test substance was instillated in the eye.
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- no
Test material
- Reference substance name:
- Dimethyl sulphate
- EC Number:
- 201-058-1
- EC Name:
- Dimethyl sulphate
- Cas Number:
- 77-78-1
- Molecular formula:
- C2H6O4S
- IUPAC Name:
- dimethyl sulfate
- Details on test material:
- - Name of test material (as cited in study report): dimethyl sulfate
- Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult animals
- Weight at study initiation: 2.26 kg (female; 2.4 kg at the end of the study) and 2.35 kg (male; 2.4 kg at the end of the study)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml - Duration of treatment / exposure:
- test substance was not washed out
- Observation period (in vivo):
- up to 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was not washed out
SCORING SYSTEM:
Ocular reactions were recorded 10 min, 1, 3, 24, 48 hours, 5, 7, and 8 days after instillation using a BASF-scoring system, which is convertible into the current OECD Draize scheme.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-48-72-hour
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- other: corneal opacity, and strong chemosis with suppuration and staphyloma remained at the end of the observation period
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72-hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- The test substance is corrosive according to the EU and to GHS
- Other effects:
- After 1 hour eyes were totally swollen. After 24 hours very strong oedema, strong redness, iritis, bleeding and corneal opacity were reported. Even after 8 days strong redness, corneal opacity, and strong chemosis with suppuration and staphyloma remained.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
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