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Registration Dossier
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EC number: 249-655-6 | CAS number: 29463-06-7
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: Scientifically acceptable study report. Basic data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Only two animals were treated.
- Principles of method if other than guideline:
- Test substance was assessed according to BASF-internal standard procedures.
- GLP compliance:
- no
Test material
- Reference substance name:
- Tris(2-hydroxyethyl)methylammonium methyl sulphate
- EC Number:
- 249-655-6
- EC Name:
- Tris(2-hydroxyethyl)methylammonium methyl sulphate
- Cas Number:
- 29463-06-7
- Molecular formula:
- C7H18NO3.CH3O4S
- IUPAC Name:
- 1,5-dihydroxy-3-(2-hydroxyethyl)pentan-3-aminium methyl sulfate
- Details on test material:
- - Substance type: organic
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 2.9 and 3.09 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.05 mL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- A slight conjunctival redness was observed in both animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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