Registration Dossier
Registration Dossier
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EC number: 247-891-4 | CAS number: 26658-19-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.33 and 2.86 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: cotton gauze patch (2.5 x 2.5 cm) which was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure, any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema 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:
- edema 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:
- Immediately after patch removal, very slight erythema was noted at one treated skin site. The effect was fully reversible within one hour. No further effects were observed at any other time point.
Any other information on results incl. tables
Both animals showed the expected body weight gain 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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