Registration Dossier
Registration Dossier
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EC number: 600-735-2 | CAS number: 106276-79-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP non-guideline study, available as unpublished report, predates implementation of GLP and/or development of study guidelines, minor restrictions in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
- GLP compliance:
- no
- Remarks:
- prior to GLP implementation
Test material
- Reference substance name:
- Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-[(2-methyl-1,3-phenylene)diimino]bis[2,3-dihydro-1H-isoindol-1-one]
- EC Number:
- 600-735-2
- Cas Number:
- 106276-79-3
- Molecular formula:
- Mixture of C23H8Cl8N4O2, C24H11Cl7N4O3, C25H14Cl6N4O4
- IUPAC Name:
- Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-[(2-methyl-1,3-phenylene)diimino]bis[2,3-dihydro-1H-isoindol-1-one]
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight: 1.5 - 2 kg
- Housing: single housing in V2A wire cages
- Diet: NAFAG, Gossau SO, rabbit food ad libitum
- Water: water ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and scarified
- Vehicle:
- other: PEG 400
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- The substance was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 animals: 3 males, 3 females
- Details on study design:
- TEST SITE
A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The test substance was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.
REMOVAL OF TEST SUBSTANCE
The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme.
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 by definite 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:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Scarified skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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