Registration Dossier
Registration Dossier
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EC number: 204-699-5 | CAS number: 124-41-4
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Well documented report, details missing
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- according to BASF-internal standards
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium methanolate
- EC Number:
- 204-699-5
- EC Name:
- Sodium methanolate
- Cas Number:
- 124-41-4
- Molecular formula:
- CH4O.Na
- IUPAC Name:
- sodium methanolate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- Amount applied: 50 µL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #1
- Time point:
- other: 1 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Grey discoloration of the nictating membrane. Severe corneal opacity. Severe pain reaction after application of the test substance.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #2
- Time point:
- other: 1 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Grey discoloration of the nictating membrane. Severe corneal opacity. Severe pain reaction after application of the test substance.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #1
- Time point:
- 24 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Grey discoloration of the nictating membrane and the conjunctiva (partly). Moderate conjuctival redness, slight oedema, severe corneal opacity. Necrosis of the edges of the eye lids.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #2
- Time point:
- 24 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Grey discoloration of the nictating membrane and the conjunctiva (partly). Moderate conjuctival redness, slight oedema, severe corneal opacity. Necrosis of the edges of the eye lids.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #1
- Time point:
- other: 8 days
- Reversibility:
- not reversible
- Remarks on result:
- other: Severe necrosis, severe suppuration, eyelids shrunken.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #2
- Time point:
- other: 8 days
- Reversibility:
- not reversible
- Remarks on result:
- other: Severe necrosis, severe suppuration, eyelids shrunken.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- due to signs of necrosis
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- due to signs of necrosis
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- due to signs of necrosis
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- due to signs of necrosis
Any other information on results incl. tables
After 1 h: Grey discoloration of the nictating membrane. Severe corneal opacity. Severe pain reaction after application of the test substance.
After 24 h: Grey discoloration of the nictating membrane and the conjunctiva (partly). Moderate conjuctival redness, slight oedema, severe corneal opacity. Necrosis of the edges of the eye lids.
After 8 days: Severe necrosis, severe suppuration, eyelids shrunken.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material was found to be corrosive to rabbit eye.
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