Registration Dossier
Registration Dossier
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EC number: 406-176-9 | CAS number: 79072-96-1 NC-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 - 27 March 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to official US test guidelines, and the study conduct was well documented in the report. The study is only considered reliable with restrictions, because no claim of GLP is made.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- EC Number:
- 406-176-9
- EC Name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- Cas Number:
- 79072-96-1
- Molecular formula:
- Hill formula: C24 H30 O6
- IUPAC Name:
- 1-[2,6-bis(4-ethylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Details on test material:
- - Name of test material (as cited in study report): NC-4
- Physical state: White powder
- Lot/batch No.: 399-P
- Storage condition of test material: Ambient temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11 to 13 weeks
- Weight at study initiation: 2.6 to 3.0 kg
- Housing: Individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): Free access to SDS Standard Rabbit Diet
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: The rabbits selected for the study were acclimated to the laboratory environment (duration not specified)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): Approximately 19
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- used to moisten the application site
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL distilled water used to moisten application site. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square
- Type of wrap if used: Gauze pad, held in place using an adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test site was washed with water at the end of the exposure period.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Day 1 (Approximately 30 minutes after removal of dressing)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Day 1 (Approximately 30 minutes after removal of dressing)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Day 4
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Day 4
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no observable response to treatment in any of the animals throughout the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- A single semi-occlusive application of NC-4 to intact rabbit skin for four hours elicited no dermal irritation.
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