Registration Dossier
Registration Dossier
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EC number: 230-896-0 | CAS number: 7360-38-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 Jun - 10 Jun 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- purity of test substance not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, mixed decanoyl and octanoyl
- EC Number:
- 277-452-2
- EC Name:
- Glycerides, mixed decanoyl and octanoyl
- Cas Number:
- 73398-61-5
- Molecular formula:
- C27H50O6 to C33H62O6
- IUPAC Name:
- Glycerides, mixed decanoyl and octanoyl
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.24-2.42 kg
- Housing: individually in suspended metal cages
- Diet: rabbit diet (Preston Farmers Ltd., Lincolnshire, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 64-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animals served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 24, 48 and 72 h - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch on the back of each rabbit
- Type of wrap if used: the treated skin was covered with surgical adhesive tape (BLENDERM), the trunk of rabbits was wrapped in an elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing: residual test material 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:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversiblity: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No skin reactions were observed during the study period in any animal.
- Other effects:
- No other local or systemic effects were observed in the study.
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.
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