Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid monosodium salt

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:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Source study has reliability 2. Details on the read across are attached in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Principles of method if other than guideline:

Appraisal of the safety of chemicals in foods drugs and cosmetics (1959) by AFDO.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 to 1.6 kg
- Housing: Singly in metal cages, overall dimensions 47×32×34 cm
- Diet: Nafag, ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 14 hrs light day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period:

8 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 × 2.5 cm with test substance was applied immediatly to the prepared skin. The patch was covered with an impermeable foil of 5 × 5 cm, which was fixed to the body of the animals with adhesive tape.
Test substance was applied to each side in quantities of 0.5 g. Before application, test material was wetted with tap water.
The gauze patches were removed 24 hours after application. Skin reaction was appraised upon removal during an observation period of 8 days on the basis of erythema and edema formation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

026/M

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

026/M

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

028/M

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

028/M

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

030/M

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

030/M

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 7

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

007/F

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

007/F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

009/F

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Results 10

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

009/F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

011/F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

011/F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Results tabulated

animal no.	erythema			oedema			mean erythema	mean oedema
	24 h	48 h	72 h	24 h	48 h	72 h
1	1	0	0	0	0	0	0.33	0
2	1	0	1	0	0	0	0.66	0
3	0	1	0	0	0	0	0.33	0
4	1	1	1	0	0	0	1	0
5	1	0	0	0	0	0	0.33	0
6	0	0	0	0	0	0	0	0

 

Erythema and Eschar Formation

0       No erythema

1       Very slight erythema (barely perceptible)

2       Well defined erythema

3       Moderate to severe erythema

4       Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Total possible erythema score 4

 

Edema formation

0       No edema

1       Very slight edema (barely perceptible)

2       Slight edema (edges of area well defined by definite raising)

3       Moderate edema (raised appoximately 1mm)

4       Severe edema (raised more than 1mm and extending beyond area of exposure)

Total possible edema score 4

 

 

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

The substance was tested as described in Appraisal of the safety of chemicals in foods drugs and cosmetics of 1959 by AFDO.
Under the conditions of the experiments the substance is not irritant when applied to intact skin of rabbits.

Executive summary:

Method

6 rabbits (3 males and 3 females) of the Russian breed were used. Test substance was applied on both intact and abraded skin in amount of 0.5 g. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 8 days.

Results

On intact skin, slight signs of erythema and oedema were noted in 5/6 rabbits. Such signs were found to be reversible within 8 days.