3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]

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:

1973

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

Test material information

Constituent 1

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

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

Results

Results 1

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

Results 2

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