Sodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzene-1-sulphonamidato(2-)]chromate(1-)

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

Study period:

July 29, 1975

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:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965).

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 1

IUPAC Name:

Similar substance 1

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Porton
- Age at study initiation: aged 10-13 weeks
- Weight at study initiation: 2.73 Kgs (♂), 2.38 kgs (♀)
- Housing: caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: Sterile filtered water ad libitum.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

other: water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
10g. of the test compound was mixed with 12 ml. of water to make a solution of 15ml. 0.75ml of which was applied to each test site on a 2.5 cm. square gauze pad.

Duration of treatment / exposure:

The gauze patches were removed 24 hours after the application.

Observation period:

The reaction of the skin was appraised upon removal and 72 hours after it.

Number of animals:

3 males/3 females

Details on study design:

TEST SITE
- Area of exposure: Two test sites lateral to the mid line of the back were used on each rabbit
- % coverage: 10 % of the total body surface.
- Type of wrap if used: 0.75ml of test compound was applied to each test site on a 2.5 cm. square gauze pad. These were covered with aluminium foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin strips of "Sleek" in order to retain the test substance in close contact with the skin.

SCORING SYSTEM: Draize et al.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 11, 13, 15, 12, 16

Time point:

other: 24, 48, 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal: 14

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

edema score

Basis:

animal: 11

Time point:

other: 24, 48, 72 hours

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal: 12

Time point:

other: 24, 48, 72 hours

Score:

0.66

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal: 13

Time point:

other: 24, 48, 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal: 14

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

edema score

Basis:

animal: 15

Time point:

other: 24, 48, 72 hours

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Results 8

Irritation parameter:

edema score

Basis:

animal: 16

Time point:

other: 24, 48, 72 hours

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Any other information on results incl. tables

Slight erythema and very slight to moderate oedema was seen on 2/6 and 5/5 rabbits respectively, 24 hours after application of the compound. All sites were normal by 72 hours.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

According to the CLP Regulation (EC n. 1272/2008)

Conclusions:

The substance is not irritating for skin rabbit.

Executive summary:

The substance has been tested for skin irritation/corrosion according to The guideline "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965). 6 Healthy New Zealand White rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the trial. Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. 10g of the test compound was mixed with 12 ml of water to make a

solution of 15 ml. 0.75ml of which was applied to each test site on a 2.5 cm square gauze pad.

Slight erythema and very slight to moderate oedema was seen on 2/6 and 5/5 rabbits respectively, 24 hours after application of the compound. All sites were normal by 72 hours. There was no marked difference in the reactions between abraded and intact sites.. The substance is not irritating for skin rabbit according to the CLP Regulation (EC n. 1272/2008).