Registration Dossier
Registration Dossier
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EC number: 252-346-9 | CAS number: 35074-77-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec. 1969 - Jan. 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study. Scientifically acceptable study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Hazardous Substances, Part 191, Section 10 and 11; FDA, Washington 1965
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- EC Number:
- 252-346-9
- EC Name:
- Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- Cas Number:
- 35074-77-2
- Molecular formula:
- C40H62O6
- IUPAC Name:
- 6-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}hexyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- - Physical state: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in house breed
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: ad libitum, Altromin K (ALTROMIN GmbH, Lage/Lippe))
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 60±3
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Concentrations: 2500 and 10000 mg/kg bw as 50% suspension. One positive control group was tested.
- Duration of treatment / exposure:
- Refer to observation period. Skin sites were not washed after 24 hours with the semiocclusive dressing.
- Observation period:
- 14 days
- Number of animals:
- 3 animals/sex/dose
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: rubber sleeve
SCORING SYSTEM: According to Draize et al.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritation regarding erythema and edema were observed either on the intact or on the abraded skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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