Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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: The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965).

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)

EC Number:

280-068-8

EC Name:

Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)

Cas Number:

82933-90-2

Molecular formula:

C16H9ClCrN4O8S2.Na

IUPAC Name:

sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)

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:

TEST ANIMALS
- Age at study initiation: 10-13 weeks
- Weight at study initiation: average body weights of 2.73 Kgs. (males) and 2.38 Kgs. (females)
- Housing:The rabbits were caged singly in an experimental room.
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: Six rabbits were acclimatized in the test area for one week prior to the start of the trial.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- 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:

semiocclusive

Preparation of test site:

abraded

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 g 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:

24 h

Observation period:

24 h and 72 h

Number of animals:

Six rabbits ( 3 male and 3 female)

Details on study design:

TEST SITE
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. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand sits remained intact.

These were covered with aluminum foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Cobon” self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

SCORING SYSTEM:
Primary irritation score Rating
0 Non irritating
0.1 - 0.5 Minimally irritating
0.6 - 1.5 Slightly irritating
1.6 - 3.0 Mildly irritating
3.1 - 5.0 Moderately irritating
5.1 - 6.5 Severely irritating
6.6 - 8.0 Extremely irritating

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animal (intact skin)

Time point:

24 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animal (intact skin)

Time point:

72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animal (Abraded skin)

Time point:

24 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animal (Abraded skin)

Time point:

72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animal (intact skin)

Time point:

24 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animal (intact skin)

Time point:

72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animal (Abraded skin)

Time point:

24 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animal (Abraded skin)

Time point:

72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

erythema score

Time point:

48 h

Remarks on result:

not measured/tested

Results 10

Irritation parameter:

edema score

Time point:

48 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

None

Other effects:

None

Any other information on results incl. tables

Erythema Formation:

No./Sex	Intact		Abraded		Total
	24 hrs	72 hrs	24 hrs	72 hrs
11	0	0	0	0
13	0	0	0	0
15	0	0	0	0
12	0	0	1	0
14	1	0	1	0
16	0	0	0	0
Mean	0.17	0	0.33	0	0.5

Oedema Formation

No./Sex	Intact		Abraded		Total
	24 hrs	72 hrs	24 hrs	72 hrs
11	2	0	3	0
13	0	0	1	0
15	2	0	2	0
12	1	0	1	0
14	3	0	2	0
16	2	0	1	0
Mean	1.67	0	1.67	0	3.33

Total Erythema + Oedema Score = 3.83

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20043/B is a slight to moderate primary skin irritant in the albino rabbit.

Executive summary:

A skin irritation potential was determined of FAT 20043/B according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965).

Slight erythema and very slight to moderate edema was seen on 2/6 and 6/6 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 primary irritation score was 1.0. FAT 20043/B is a slight primary skin irritant in the albino rabbit. Based on the finding in the skin irritation studies, the test substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.