Registration Dossier
Registration Dossier
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EC number: 234-277-6 | CAS number: 11059-65-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study; well documented study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 40CFR Section 163.81-5, Federal Register, August 22, 1978 and subsequently modified in accordance with the revised EPA pesticide Assessment Guidelines of November 1982.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Inc., Douglassville, PA 19518.
- Housing: Stainless steel cages with elevated wire mesh flooring, 1 rabbit/cage.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-75F.
- Humidity (%):55% +/- 25.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
IN-LIFE DATES: 19 August 1986 to 02 September 1986.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- The test substance was administered once per site and remained in contact with the skin for 4 hours followed by removal with white mineral oil.
- Observation period:
- The skin was examined and graded for dermal reaction within 30-60 minutes following patch removal. Readings were also made after 24, 48 and 72 hours and on days 7 and 14
- Number of animals:
- Six rabbits
- Details on study design:
- TEST SITE
- Approximately 24 hours prior to application, the hair was clipped from the backs of the rabbits. Each animal received a 0.5 ml dose applied to the test site. Gauze patches were placed over the treated and control areas which were held in place with non-irritating tape. A suitable semi-occlusive dressing was wrapped around the trunks of the animals to hold the patches in place. Following the exposure period, the test sites were wiped with white oil.
SCORING SYSTEM: : Dermal Irritation was graded in accordance with the Draize method of scoring.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24. 48 and 72 hours
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.7
- Max. score:
- 8
- Reversibility:
- no data
- Remarks:
- not applicable
- Irritant / corrosive response data:
- The test article produced mild skin irritation in albino rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the results of this study, the test substance would not be classified as a non- irritant in accordance with the classification system of GHS.
- Executive summary:
The primary dermal irritation potential of the test material was evaluated in this study with New Zealand White rabbits. A single 0.5 ml dose of the test material was applied to a single site on each animal's back.Alldoses were applied under semi-occlusive dressing for a four hour exposure period. At completion of exposure the bandages were removed and the sites washed with white. Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes following patch removal.were also made after 24, 48 and 72 hours and on days 7 and 14.
ThePrimary Irritation Index was calculated to be 1.7 for sites treated with the test material.
Based on the results of this study, the test substance is not an irritant in accordance with the classification system of GHS.
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