Registration Dossier
Registration Dossier
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EC number: 217-090-4 | CAS number: 1738-25-6
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: Comparable to guideline with acceptable restrictions (partly limited documentation, 50 μl instead of 100 μl test substance instilled)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- application volume (50 µL instead of 100 µL)
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-dimethylaminopropiononitrile
- EC Number:
- 217-090-4
- EC Name:
- 3-dimethylaminopropiononitrile
- Cas Number:
- 1738-25-6
- Molecular formula:
- C5H10N2
- IUPAC Name:
- 3-(dimethylamino)propanenitrile
- Details on test material:
- - Name of test material (as cited in study report): N,N-Dimethyl-amino-propionitril
- Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one drop of saline into the other eye
- Amount / concentration applied:
- 50 µL
- Duration of treatment / exposure:
- The eye was left unwashed.
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24- 48 - 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: Smeary layer were observed in both treated eyes until readings after 72 h and 4 d, respectively
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24- 48 - 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24- 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Applicant's summary and conclusion
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