Hydrogen 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 28, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

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:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Orange 060 - Similar Substance 01

IUPAC Name:

Acid Orange 060 - Similar Substance 01

Test material form:

solid: particulate/powder

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 kg (males) and 2.38 kg (females)
- Housing:The rabbits were caged singly in an experimental room.
- Diet (e.g. ad libitum): a commercial irradiated diet (Styles-Oxoid) was fed ad libitum.
- Water (e.g. ad libitum): 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 0.75 ml of which was applied to each test- site on a 2.5 cm square gauze pad.

Duration of treatment / exposure:

24 hours

Observation period:

24 hours and 72 hours

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:

animal: 11, 12, 13, 15, 16

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no symptoms

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

erythema score

Basis:

animal: 14

Time point:

24/48/72 h

Score:

ca. 0.66

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Results 3

Irritation parameter:

edema score

Basis:

animal: 11, 15, 16

Time point:

24/48/72 h

Score:

ca. 1.66

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Results 4

Irritation parameter:

edema score

Basis:

animal: 12

Time point:

24/48/72 h

Score:

ca. 0.66

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Results 5

Irritation parameter:

edema score

Basis:

animal: 13

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no symptoms

Remarks on result:

other: intact skin

Results 6

Irritation parameter:

edema score

Basis:

animal: 14

Time point:

24/48/72 h

Score:

ca. 2.66

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

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:

other: CLP criteria not met

Conclusions:

Not irritant

Executive summary:

Method

The skin irritation potential of the test substance was determined according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965).

 

Observations

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.

 

Conclusion

Not irritant