Registration Dossier
Registration Dossier
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EC number: 950-485-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 Jan 2009 to 10 Jan 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Deviations: occlusive dressing; 24h exposure; tested on abraded and non-abraded skin at 10% and 100% on each animal
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- yes
- Remarks:
- occlusive dressing; 24h exposure; tested on abraded and non-abraded skin at 10% and 100% on each animal
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate
- Molecular formula:
- C19H36O6
- IUPAC Name:
- 1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate
1
Test animals
- Species:
- rabbit
- Strain:
- other: Jla:JW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Age at study initiation: 18 weeks
- Weight at study initiation: 3.42 to 3.61 kg
- Housing: individual housed in aluminum cages with wire mesh bottoms
- Diet: RC4 pelleted diet (Oriental Yeast Co., Ltd., Lot No. 080916), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5
- Humidity (%): 55 ± 25
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 7 Jan 2009 To: 10 Jan 2009
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: liquid paraffin
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 10 and 100% (w/w)
VEHICLE
- Lot/batch no.: PEK3961 (Wako Pure Chemical Industries, Co., Ltd.) - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm² (2 areas with intact skin, 2 areas with abraded skin)
- Type of wrap if used: occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: after patch removal, application sites were wiped with absorbent cotton soaked with water for injection
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS
24, 48 and 72 h (observation and scoring of primary skin irritation)
Clinical signs: immediately after patch removal, 1 h and 4 h after application and once daily thereafter until day 3 after application
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 100% test material and 10% test material in liquid paraffine
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 100% test material and 10% test material in liquid paraffine
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin reactions were observed in any animal after application of 10 and 100% test substance.
- Other effects:
- - Other adverse systemic effects: There were no abnormalities in clinical signs or body weight gain observed in any animal until the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The test substance did not exhibit skin irritating properties in the conducted study.
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