Registration Dossier
Registration Dossier
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EC number: 247-891-4 | CAS number: 26658-19-5
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:
- weight of evidence
- 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 guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
Test material
- Reference substance name:
- Anhydro-D-glucitol trioleate
- EC Number:
- 247-569-3
- EC Name:
- Anhydro-D-glucitol trioleate
- Cas Number:
- 26266-58-0
- IUPAC Name:
- 1,4-anhydro-2,3,6-tri-O-oleoyl-L-iditol
- Details on test material:
- - Name of test material (as cited in study report): anhydro-D-glucitol trioleate
- Physical state: amber coloured liquid
- Analytical purity: The integrity of supplied data relating to the purity of the test item is the responsibility of the Sponsor.
- Batch No.: 0000444978
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.58 and 2.96 kg
- Housing: individually in suspended cages
- Diet (ad libitum): mains drinking water
- Water (ad libitum): 2930C Teklard Global Rabbit diet
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 3 days
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: light source from a standard opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: mean over 24,48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: mean over 24,48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24,48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24,48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: mean over 24,48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- 1 h post-instillation: conjunctival redness and chemosis grade 1 was observed in both animals. Corneal opacity and iritis were not observed. Conjunctival discharge grade 1 was observed in one animal.
24 h post-instillation: conjunctival redness grade 1 was observed in one animal. The effect was fully reversible within 48 h. Corneal opacity, iritis, chemosis and discharge were not observed.
48-72 h post-instillation: no eye effects were observed in any animal. - Other effects:
- Both animals showed expected gain in body weight during the study.
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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