Registration Dossier
Registration Dossier
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EC number: 237-360-5 | CAS number: 13762-51-1
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: Basic data given
- Justification for type of information:
- The study is well documented following general scientific practice.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Animals were placed in a collar. The test substance was instilled in one eye, the other untreated eye served as a control. Scoring was at 24, 48 and 72 hours after instillation and any residue of the test material and accumulated discharge was flushed from the eye each time they were scored.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium tetrahydroborate
- EC Number:
- 241-004-4
- EC Name:
- Sodium tetrahydroborate
- Cas Number:
- 16940-66-2
- Molecular formula:
- BH4.Na
- IUPAC Name:
- Sodium tetrahydridoborate(1–)
- Details on test material:
- - Name of test material (as cited in study report): Sodium borohydride pawder
- Physical state: powder
- Lot/batch No.: 3-97
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): n/a
VEHICLE- no vehicle - Duration of treatment / exposure:
- Residue was flushed from the eye each time they were scored. Eyes were completely destroyed by 24 hours.
- Observation period (in vivo):
- Eyes were completely destroyed by 24 hours.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): residue and accumulated discharge was flushed at each reading
- Time after start of exposure: 24 hours
SCORING SYSTEM: read according to the scale of scoring for damage to the cornea, iris and bulbar and palpebral conjunctivae
TOOL USED TO ASSESS SCORE: not reported
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Eye completely destroyed by 24 hours
- Basis:
- mean
- Time point:
- other: 24 h
- Reversibility:
- not reversible
- Remarks on result:
- other: No scores reported. Eyes completely destroyed by 24 hours
Any other information on results incl. tables
Eyes completely destroyed by 24 hours. Protein of eye appeared to be completely denatured.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Eye were completely destroyed by 24 hours post dose.
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