Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive testing conditions represent elevated testing conditions compared to OECD guideline 404

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Principles of method if other than guideline:

None

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

EC Number:

279-317-3

EC Name:

Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

Cas Number:

79828-43-6

Molecular formula:

C38H18Cl2CrN16O20S4.5Na

IUPAC Name:

Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The test was performed on 1 male and 2 female rabbits, weighing between 2.5 to 3.0 kg (approx. 15-16 weeks old). The acclimation was 4 days under laboratory conditions after veterinary examination. Body weights were measured on day 1 and at termination of test.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: moistened with tap water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

on the test day 1, 0.5 g test article was applied to the intact skin of the shaved area. The test article was moistened with tap water.

Duration of treatment / exposure:

four hours

Observation period:

at 1, 24, 48, 72 hrs intervals after the removal of the dressing, gauze patch and test article.

Number of animals:

1 male and 2 females

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10×10 cm). On test day 1, 0.5 g of the test article was applied to the intact skin of the shaved area. It was covered with a 3.0×3.0 cm patch of surgical gauze. The gauze was covered with aluminum foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. Four hrs after the application, the dressing was removed and the skin was flushed with lake warm tap water.
at 1,24,48,72 hrs after patch removal, any lesions, a description of the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

other: 1 hr

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

48 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

other: 1 hr

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

48 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

None

Other effects:

In the area of application a black discoloration of the skin was observed.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40210/A was not found to cause a primary skin irritation when applied to intact rabbit skin.

Executive summary:

A key study was performed to determine the skin irritation of FAT 40210/A according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion).

There were 1 male and 2 female rabbits used in this test under the standard laboratory conditions. In the area of application a black discolouration of the skin was observed which could be related to effects of the test article. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

Under the conditions of this experiment, FAT 40210/A was found to cause a primary irritation score of 0 when applied to intact rabbit skin, which shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).