Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[(2,2,4-trimethylcyclohexyl)amino]anthracene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Remarks:

source of read across

Adequacy of study:

key study

Study period:

From May 26 to August 15, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Association of Breeders of Hradec Kralove.
- Weight at study initiation: above 2.5 kg.
- Housing: the rabbits were house invidually in metal cages commercially produced without bedding, with automatic air-condition.
- Diet: rabbits were fed standard commercially manufacturing feed mixture TM-rabbit, ad libitum.
- Water: drinking water according to CSN 757111 ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ± 15 %
- Photoperiod:12 hrs cycle dark /light
- Other: fluorescent light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: an area of 6 cm × 6 cm was depilated. For the formation of scarified skin, four horizontal and four vertical incisions were made. Depilated area of​​ skin outside of the application zone was used to control the assessment.
- Type of wrap if used: the sample was covered with gauze, above which aluminum film and cellulose wadding was applied. Technical tape was used so that the test substance was in contact with the depilated skin.

SCORING SYSTEM
The degree of erythema was diagnosed visually, and the degree of edema was assessed by visual examination and palpation, according to the OECD guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The mean erythema and edema score for the three rabbits is 0.
At 4, 24, 48 and 72 hours after removal of patch no rmacroscopic or pathomorphological changes were identified on the intact or scarified skin. The present sample after epicutaneous application to the skin of rabbits did not induce contact dermatitis.

Any other information on results incl. tables

Animal No	Reaction	Intact skin				Scarified skin
		4 hrs	24 hrs	48 hrs	72 hrs	4 hrs	24 hrs	48 hrs	72 hrs
14	Erythema	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0
29	Erythema	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0
30	Erythema	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Not irritant

Executive summary:

The substance was evaluated for skin irritation/ corossion, according to OECD guideline 404. The test substance (0.5 g) was applied as a paste on the intact (left lateral depilated area) and scarified skin (right lateral depilated area) of three New Zealand white rabbits. Depilated area of skin outside the application zone was used to control the assessment.

After 4, 24, 48 and 72 hours of the removal of the patch the animals were examined for signs of erythema and ethema. No edema or erythema signs were identified on the intact skin and neither on the scarified skin.

Based on erythema and edema scores, the test substance is not considered to be irritating to the skin.

Conclusion

None of the animals showed any observable response to treatment throughout the 72 hours observation period, in both the cases of intact and scarified skin. Therefore, it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC 1272/2008).