Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
1978
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

Constituent 1
Chemical structure
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:
3-({3-carboxy-1,4,5,6,7,7-hexachlorobicyclo[2.2.1]hept-5-ene-2-carbonyloxy}carbonyl)-1,4,5,6,7,7-hexachlorobicyclo[2.2.1]hept-5-ene-2-carboxylic acid
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

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.