Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 July 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

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).

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

EC Number:

274-503-0

EC Name:

Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Cas Number:

70247-74-4

Molecular formula:

C34H30Cl2CoN8O10S2.Na

IUPAC Name:

sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation:1.9 to 2.2 kg
- Housing:They were housed singly in metal cages (overall dimensions 47x32x34 cm).
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days

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

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

electric clipper

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

6 rabbits (3 males and 3 females)

Details on study design:

The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. FAT 20 035/A was applied to each side in quantities of 0.5 g. Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application.

Assessment of irritation
0 = none
>0-1 = minimal
>1 - 2 = slight
>2 - 4 = moderate
>4 - 6 = marked
>6 - 8 = extreme

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

intact and abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Remarks:

intact and abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

48 h

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

erythema score

Remarks:

intact and abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Remarks:

intact and abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Remarks:

intact and abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

48 h

Remarks on result:

not measured/tested

Results 6

Irritation parameter:

edema score

Remarks:

intact and abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Non-irritant and non corrosive.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20035/A was found to be non-irritant when applied to intact or abraded rabbit skin.

Executive summary:

A in vivo test was carried out for finding out the primary irritation index as a measure of the acute irritation on the skin of rabbits with test compound FAT 20035. The method followed was patch test technique as 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).

6 rabbits (3 male and 3 female) were observed for 7 days after test substance application. The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. FAT 20 035/A was applied to each side in quantities of 0.5 g . Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application.

Results showed no adverse reactions at all at any experimental time period, erythema and edema score at 24, 48 and 72 h was '0'. Under the conditions of this experiment FAT 20035/A was found to be non-irritant when applied to the intact or abraded rabbit skin.