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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(mostly due to limited documentation before GLP (no data on test substance purity); Draize-test)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO) / Draize

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-(3-chloro-o-tolyl)benzamide]

EC Number:

226-970-7

EC Name:

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

Cas Number:

5580-57-4

Molecular formula:

C43H35Cl5N8O6

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-(3-chloro-2-methylphenyl)benzamide]

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.2 to 1.9 kg
- Housing: individually
- Diet: standard diet of Nafag, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 / 14

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved: intact and abraded skin

Vehicle:

other: moistened with tap water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 h

Observation period:

7 days

Number of animals:

6 (3 male and 3 female animals)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The gauze patch with the test substance was covered with an impermeable foil of 5 x 5 cm, which was fixed to the body of the animals with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: no washing conducted

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(animal 1-6)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact and abraded skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(animal 1-6)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact and abraded skin

Irritant / corrosive response data:

No erythema and edema were observed in any animal during the whole observation period.

Any other information on results incl. tables

Only the results from the intact skin were taken into account for assessment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this experiment the test substance was found to be non irritant when applied to intact rabbit skin.