Registration Dossier
Registration Dossier
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EC number: 600-709-0 | CAS number: 106006-84-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1995
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- checked
- IUPAC Name:
- checked
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- one time treatment
- Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- 2 m and 2 f
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 72 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 72 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 72 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 72 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal #4
- Time point:
- other: 1 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- 1 h post administrations , only a slight redness of the conjunctiva was seen in all four rabbits. It was no longer evident 24 h post administration. Mean maximal score for conjunctival redness was 1.0.
No other findings were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- No special labelling is necessary in accordance with German regulations regarding eye irritation.
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