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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Principles of method if other than guideline:

6 rabbits; application on intact and and wound skin; observations at 24 and 72 h for erythema and oedema.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Direct Red 111

IUPAC Name:

Direct Red 111

Test animals

Species:

rabbit

Test system

Type of coverage:

not specified

Preparation of test site:

other: intact and wound

Vehicle:

not specified

Controls:

no

Observation period:

72 h

Number of animals:

6

Details on study design:

OBSERVATION TIME POINTS
24 h and 72 h

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #3, #4

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: 48 h score assumed to be equal to the highest score between 24 and 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2, #5, #6

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: 48 h score assumed to be equal to the highest score between 24 and 72 h

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: 48 h score assumed to be equal to the highest score between 24 and 72 h

Any other information on results incl. tables

animal	skin	erythema		oedema
		24 h	72 h	24 h	72 h
#1	intact	2	0	1	0
	wound	2	1	2	1
#2	intact	1	0	1	0
	wound	1	0	1	0
#3	intact	2	0	1	0
	wound	2	0	2	0
#4	intact	2	0	1	0
	wound	2	0	2	0
#5	intact	1	0	1	0
	wound	2	0	2	1
#6	intact	1	0	1	0
	wound	1	0	2	1

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Not irritant to rabbit skin.

Executive summary:

Method

Test substance was applied on intact and wound skin of 6 rabbits; observations for erythema and oedema were done at 24 and 72 h.

Results

Signs of irritation on intact skin were noted at 24 h and were fully reversible within the 72 h observation period. Signs of irritation on wound skin were not completely reversible within the 72 h observation period; however they showed a clear tendency to decrease.