Registration Dossier
Registration Dossier
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EC number: 226-971-2 | CAS number: 5580-58-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study (Draize test) with acceptable restrictions (occlusive dressing, intact and abraded skin test sites, TS substance preparation: 50%, 24 hours exposure duration, no details on test animals, only 24- and 72-hour scoring available, 72-hour observation period; TS purity not specified; non GLP)
- Justification for type of information:
- Category approach as part of CSR.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 38 No. 187 § 1500.41
- Deviations:
- yes
- Remarks:
- 48 h reading not performed
- Principles of method if other than guideline:
- Patch-test similar to the Draize test
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]
- EC Number:
- 279-356-6
- EC Name:
- 3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]
- Cas Number:
- 79953-85-8
- Molecular formula:
- C55H37Cl5F6N8O8
- IUPAC Name:
- 3,3'-{(2-chloro-5-methyl-1,4-phenylene)bis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}bis{4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide}
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: individually (after shaving to prevent injuries by bites) in V2A wire cages
- Diet (e.g. ad libitum): NAFAG, Gossau SG, rabbit food; ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
No additional details provided
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved or abraded (only data from the shaved skin sites are presented here, since they are suitable for assessment)
- Vehicle:
- other: The test material was prepared for application in polyethylene glycol (PEG; prepared as 7 parts PEG: 3 parts saline solution).
- Controls:
- other: untreated skin sites of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): as 50% trituration in polyethylene glycol - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of the right flank (the whole back and flanks was shaved with an electric clipper 2 days before treatment). The shaven skin on the left side was slightly scarified immediately before treatment.
- % coverage: the patch was covered with a plastic film (5 cm x 5 cm))
- Type of wrap if used: the plastic film was fixed to the body with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: the gauze patches were removed 24 hours after the application
SCORING SYSTEM: comparable to the OECD scoring system (only 24- and 72-hour scores were determined)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Mean of all tested animals
- Time point:
- other: 24-72-hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 48-hour scoring not performed
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Mean of all tested animals
- Time point:
- other: 24-72-hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 48-hour scoring not performed
- Irritant / corrosive response data:
- No irritation was observed, neither on intact skin sites nor on the abraded ones. It could therefore be assumed that the test substance is not irritating according to EU-CLP.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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