Sodium 3-[[4-[(2-ethoxy-5-methylphenyl)azo]-1-naphthyl]azo]benzenesulphonate

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:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

Test conducted following Code of Federal Regulations, Title 16, section 1500.41

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Orange 116

IUPAC Name:

Acid Orange 116

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
- Weight at study initiation: 3.2 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 - 14 d

ENVIRONMENTAL CONDITIONS
- Temperature: 16 - 18 °C
- Humidity: 40 %
- Photoperiod hrs dark / hrs light: 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg
- Concentration: diluted 1:1 in water

Duration of treatment / exposure:

24 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 × 2.5 cm
- Type of wrap if used: elastic permanent

PREPARATION OF TEST SITE
The flank skin of 6 rabbits was depilated on an area of ​​about 8 × 8 cm on both sides of the trunk with an electric hair clipper 24 hours before the start of the test. The right flank skin was also skarified by means of a cupping cupper.

OBSERVATION TIME POINTS
24 h (at removal of bandage, 48 h, 72 h and 8 days after start of the test

SCORING SYSTEM:
Erythema
0 no erythema
1 very slight, almost imperceptible erythema
2 well-developed erythema
3 moderate to severe erythema
4 severe erythema (dark red) to mild scabbing (deep skin injury) - burns

Oedema
0 no oedema
1 very slight, almost imperceptible oedema
2 mild edema (limits well marked by clear lifting)
3 moderate oedema (approximately 1 mm lift)
4 severe oedema (lifting more than 1 mm and exceeding the limits of the application)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

due to staining of skin

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: score at 48 h, assumed as equal to highest score at 24 or 72 h

Results 3

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other:

Remarks:

score at 48 h, assumed as equal to highest score at 24 or 72 h

Results 4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: score at 48 h, assumed as equal to highest score at 24 or 72 h

Results 5

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: score at 48 h, assumed as equal to highest score at 24 or 72 h

Results 6

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: score at 48 h, assumed as equal to highest score at 24 or 72 h

Results 7

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: score at 48 h, assumed as equal to highest score at 24 or 72 h

Any other information on results incl. tables

		time	skin irritation / animal no.
			1	2	3	4	5	6
erythema	intact	24 h	*	*	*	*	*	*
		72 h	*	*	*	*	*	*
		8 d	*	*	*	*	*	*
	scarified	24 h	*	*	*	*	*	*
		72 h	*	*	*	*	*	*
		8 d	*	*	*	*	*	*
oedema	intact	24 h	2	1	3	3	3	3
		72 h	1	0	2	1	1	2
		8 d	0	1	2	2	0	0
	scarified	24 h	3	2	4	3	4	4
		72 h	3	1	3	2	3	3
		8 d	3	1	3	2	2	3

* Reading not possible due to substance-related staining of skin

Applicant's summary and conclusion

Interpretation of results:

other: skin irritant according to the CLP regulation (EC 1272/2008)

Conclusions:

Irritant to the rabbit skin.

Executive summary:

Method

Skin irritation assessement based on Code of Federal Regulations, Title 16, section 1500.41. Test substance was applied on clipped skin of 6 rabbits, both intact and scarified, under occlusive coverage for 24 h. Observations were done after 24 h , 48 h (not reported), 72 h and up to 8 d after starting of experiment.

Results

Presence of erythema could not be ascertained due to staining. Oedema was noted in all rabbits; more pronounced effects were reported on scarified skin with respect to intact skin. In all but one cases, effects decreased upon 8 days.