Registration Dossier
Registration Dossier
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EC number: 306-085-3 | CAS number: 95912-89-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 11 - 15 Jun 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 921-836-0
- EC Number:
- 921-836-0
- IUPAC Name:
- 921-836-0
- Details on test material:
- - Name of test material (as cited in study report): [trade name]
- Analytical purity: no data
- Physical state/appearance: dark liquid
- Bach No.: 103991
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bettinardi Breeding, Momo, Italia
- Weight at study initiation: 3120 - 3220 g
- Housing: individually in NORYL cages
- Diet: standard pellet complete diet
- Water: purified water; ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- one single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h after appliction - Number of animals or in vitro replicates:
- 3 (males)
- Details on study design:
- SCORING SYSTEM: accoring to the Draize Scoring System
TOOL USED TO ASSESS SCORE: ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: score = 1 in all animals at reading time point 1 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effects
- Irritant / corrosive response data:
- No effects on cornea, iris or conjunctivae swelling (chemosis) were observed in any animal during the study. Conjunctivae redness (score = 1) was seen in all animals only at the 1 h reading time point.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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