Registration Dossier
Registration Dossier
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EC number: 204-077-3 | CAS number: 115-27-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken and reported scientifically but not to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
- EC Number:
- 204-077-3
- EC Name:
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
- Cas Number:
- 115-27-5
- Molecular formula:
- C9H2Cl6O3
- IUPAC Name:
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
- Details on test material:
- - Name of test material (as cited in study report): Chlorendic anhydride- Analytical purity: 98.81%- Lot/batch No.: 3-12-206
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Sweetwater Farms, Hillsboro, Ohio- Age at study initiation: - Weight at study initiation: 2174 to 2861 g- Housing: Hanging wire-mesh cages- Diet: Purina Rabbit Chow, ad libitum - Water: ad libitum- Acclimation period:ENVIRONMENTAL CONDITIONS- Temperature (°C): - Humidity (%): - Air changes (per hr): - Photoperiod (hrs dark / hrs light):IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 500 mg- Concentration (if solution):VEHICLE- Amount(s) applied (volume or weight with unit):- Concentration (if solution):- Lot/batch no. (if required): - Purity:
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Immediately after bandages were removed and at 24, 48 and 72 hours.
- Number of animals:
- 6
- Details on study design:
- TEST SITE- Area of exposure: - % coverage: - Type of wrap if used: gauze bandaging and occluded with Saran WrapREMOVAL OF TEST SUBSTANCE- Washing (if done): Yes, with tepid water.- Time after start of exposure: 4 hoursSCORING SYSTEM:Erythema and Eschar FormationNo erythema 0Very Slight erythema( barely perceptible) 1Well defined erythema 2Moderate to severe erythema 3Severe erythema (beet redness) to slighteschar formation (injuries of depth) 4Edema FormationNo edema 0Very slight edema barely perceptible 1Slight edema edges or area well derinedby definite raising 2Moderate edema raised approximately 1.0 mm 3Severe edema raised more than 1.0 mm extendingbeyond the area of exposure 4Mean Primarv Irritation Score EvaluationRange of Values Descriptive Rating 0 Non-irritating 0.1 to 0.5 Minimally irritating 0.6 to 1.5 Slightly Irritating 1.6 to 3.0 Mildly Irritating 3.1 to 5.0 Moderately Irritating 5.1 to 6.5 Severely Irritating 6.6 to 8.0 Extremely Irritating
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.6
- Max. score:
- 0.5
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.19
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.8
- Reversibility:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: not specified
- Conclusions:
- Based upon the results obtained, the test material would not be considered a primary skin irritant or a corrosive material.
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