2-[-N-(2-cyanoethyl)-4-[(p-nitrophenyl)azo]anilino]ethyl benzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 August 1998 to 21 August 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

Disperse Orange 288

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: New Zealand albino rabbit
Origin: Charles River Deutschland GmbH
Number of animals: 3
Body weight at start of the study: 2.8-3.0 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20±3°C
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily
Acclimatisation: 1 week under study conditions
Food: ssniff® K-H (V2333), ad libitum and hay (approx. 15 g daily)
Water: water from automatic water dispensers, ad libitum
Animal identification: numbered ear tags

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: sesame oil

Controls:

no

Amount / concentration applied:

Dose levels: 500 mg per patch
Each animal was treated with 0.5 g test substance pasted with 1.0 ml sesame oil (Oleum sesami DAB 10).

Duration of treatment / exposure:

Exposure 4 hours

Observation period:

72 hours after removal of patch

Number of animals:

3

Details on study design:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.

Each animal was treated with 0.5 g test substance pasted with 1.0 ml sesame oil (Oleum sesami DAB 10). The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.

Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 3 days

Remarks on result:

no indication of irritation

Remarks:

skin discoloured orange

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 3 days

Remarks on result:

no indication of irritation

Remarks:

skin discoloured orange

Irritant / corrosive response data:

The reversibility results detailed correspond to minor skin discolouration. No other effects were noted. Three days after removal of the patch the irritations were reversible

Other effects:

From one hour up to one day after removal of the patch the skin surface of the animals was discoloured orange.

Any other information on results incl. tables

Generalised Results by Animal – Animals Against Parameters – Multiple Times

Activity : Skin Irritation Results

Study: 98.0574 – Skin Irritation Test in Rabbits

Group sex	Animal Number	Day Number	Time Slot	Bodyweight g	Treated Flank	Duration Treatment	Erythema	Edema
1f	313	1		2840	Left	4 hours
			30-60 min. after decontamination				0	0
		2	24 hours after decontamination				0	0
		3	48 hours after decontamination				0	0
		4	72 hours after decontamination				0	0
	314	1		2800	Left	4 hours
			30-60 min. after decontamination				0	0
		2	24 hours after decontamination				0	0
		3	48 hours after decontamination				0	0
		4	72 hours after decontamination				0	0
	315	1		2930	Left	4 hours
			30-60 min. after decontamination				0	0
		2	24 hours after decontamination				0	0
		3	48 hours after decontamination				0	0
		4	72 hours after decontamination				0	0

Nominal Dose: Group 1 – 0.5g (moistened)

 

Clinical Observations – Clinical Signs by Animal

Study: 98.0574 – Skin Irritation Test in Rabbits

Day numbers relative to Start Date
Group Sex	Animal Number	Clinical Sign	1	2	3	4
			30-60 min a. decom.	24 hours a. decom.	48 hours a. decom.	72 hours a. decom
1f	313	No Abnormalities Detected	-	-	X	X
		Skin Discoloured- Small Area	O	O	-	-
	314	No Abnormalities Detected	-	-	X	X
		Skin Discoloured – Small Area	O	O	-	-
	315	No Abnormalities Detected	-	-	X	X
		Skin Discoloured – Small Area	O	O	-	-

X = Present   O = orange

Nominal Dose: Group 1 – 0.5g (moistened)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study the test substance is not irritating to skin.

Executive summary:

The present study was conducted in compliance with EEC-Guideline B.4."Acute Toxicity Skin Irritation" of the Directive 92/69/EEC: Commission Directive of July 31,1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances and OECD Guidelines for Testing of Chemicals, 404 „Acute Dermal Irritation / Corrosion", updated guideline, adopted: July 17,1992

From one hour up to one day after removal of the patch the skin surface of the animals was discolored orange.

Three days after removal of the patch the irritations were reversible

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated as zero. No effects other than skin staining were noted.

The substance is not considered to be an irritant to the skin.