Registration Dossier
Registration Dossier
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EC number: 253-039-2 | CAS number: 36443-68-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22.10.1979 to 12.11.1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- light/dark cycle, observation times, exposure time and the use of both intact and abraded skin.
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- EC Number:
- 253-039-2
- EC Name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- Cas Number:
- 36443-68-2
- Molecular formula:
- C34H50O8
- IUPAC Name:
- ethane-1,2-diylbis(oxyethane-2,1-diyl) bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propanoate]
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Limited (Toxicology GU 2.1)
- Weight at study initiation: 2 to 3 kgs
- Housing: Individually in metal cages
- Diet: ad libitum standard rabbit food NAFAG No. 814
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Photoperiod (hrs dark / hrs light): 14 hrs dark/ 10 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Abraded and intact shaved
- Vehicle:
- other: Propylene glycol and saline (70:30)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 50%
- amount: 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 X 2.5 cm
- Type of wrap if used: impermeable material
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 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
Total possible erythema score = 4
Edema formation
No edema = 0
Very slight edema (barely perceptible) = 1
Slight edema (edges of area well defined bydefinite raising) = 2
Moderate edema (raised approximately 1 mm) = 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) = 4
Total possible edema score = 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: for both intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: values for both intact and abraded skin
- Irritant / corrosive response data:
- No erythema or edema was observed on any of the test animals on abraded or intact skin.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present experiment the test article was found to cause no irritation when applied to intact and abraded rabbit skin.
- Executive summary:
In a skin irritation study predating GLP the test substance was investigated for dermal effects in rabbits in a test similar to OECD testing guideline 404. An amount of 0.5 g test material was applied to the skin of 3 male and 3 female adult New Zealand White rabbits in an occlusive manner. The protocol differed by additional testing of abraded skin versus intact skin and a prolonged exposure time of 24h was used. Observation was terminated after 7 days which is acceptable as no indication of erythema or erythema was observed during the observation period. All scores for edema and erythema were zero at any time point. Based on the results of this study, the test article is considered to be not irritating to the rabbit skin.
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