4-(phenylazo)benzene-1,3-diamine acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

data is from experimental reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

To assess the dermal irritation potential of 4-nitrobenzene-1,3-diamine in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-nitro-m-phenylenediamine

EC Number:

225-876-3

EC Name:

4-nitro-m-phenylenediamine

Cas Number:

5131-58-8

Molecular formula:

C6H7N3O2

IUPAC Name:

4-nitrobenzene-1,3-diamine

Test material form:

solid

Details on test material:

- Name of test material : 4-Nitro-m-phenylenediamine
- Molecular formula : C6H7N3O2
- Molecular weight : 153.14 g/mol
- Smiles notation : c1(c(cc(N)cc1)N)[N+](=O)[O-]
- InChl (if other than submission substance): 1S/C6H7N3O2/c7-4-1-2-6(9(10)11)5(8)3-4/h1-3H,7-8H2
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material : 4-Nitro-m-phenylenediamine
- Molecular formula : C6H7N3O2
- Molecular weight : 153.14 g/mol
- Smiles notation : c1(c(cc(N)cc1)N)[N+](=O)[O-]
- InChl (if other than submission substance): 1S/C6H7N3O2/c7-4-1-2-6(9(10)11)5(8)3-4/h1-3H,7-8H2
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill ltd, Huntingdon, UK
- Age at study initiation: Not reported
- Weight at study initiation: average about 3 kg
- Housing: The animals were housed individually
- Diet (e.g. ad libitum): "muemmel Z-222" (Hoeing Kraftfutterwerk Lower Saxony, Verden / Aller), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 40-50%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle (artificial lighting. 7 - 19 h)

IN-LIFE DATES: From: To: Not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes

Amount / concentration applied:

0.5 g of creamed with water test substance were applied.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 h after removal of the lobules and conclusion of the test after 10 test day.

Number of animals:

3 male animals

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: full
- Type of wrap if used: Gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: As per the method of Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hrs

Score:

1.3

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hrs

Score:

0.3

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hrs

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

After one hour, a yellowish discoloration of the skin was found. Discoloration held until the 9th day of the experiment at (Animal No. 4). The animals were followed up until the 10th day of the experiment,

Any other information on results incl. tables

	Time after patch removal	Skin irritation Animal No.			Total	Average
		3	4	5
Erythema	1 hr	1	3	1	-	-
	24 hr	1	2	1	4	1.3
	48 hr	1	2	1	-	-
	72 hr	1	1	0	2	0.7
	Experimental end	0	0	0	-	-
Edema	1 hr	0	0	0	-	-
	24 hr	0	0	0	0	0
	48 hr	0	0	0	-	-
	72 hr	0	0	0	0	0
	Experimental end	0	0	0	-	-

The sum of the average stimulus values after 24 h (erythema = 1.3, edema = 0) and 72 h (erythema = 0.7, edema = 0) obtained by dividing by the number of these time points (by 2) gave a primary irritation score of 1.0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The sum of the average stimulus values after 24 h (erythema = 1.3, edema = 0) and 72 h (erythema = 0.7, edema = 0) obtained by dividing by the number of these time points (by 2) gave a primary irritation score of 1.0.
From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be irritating according to the E.C Commission's proposal on criteria for effects and irritants as set out in Annex VI II B 6 Directive.

Executive summary:

The primary skin irritation of 4-nitro-m-phenylenediamine was assessed in a study conducted on rabbits as per OECD Guideline 404.

The flank skin of 3 male New Zealand White rabbits was depilated on both sides on an area of approximately 6 x 6 cm with an electric clipper with suction for 24 hours before starting the test. In the experiment only animals with intact skin were taken. 0.5 g of 4 -nitro-m-phenylenediamine was applied under occlusion to clipped intact skin of the flank. The untreated side served as a control.The survey findings was performed 1, 24, 48 and 72 h after removal of the lobules and conclusion of the test after 10 test day. The stimulus values ​​after 24 and 72 h were averaged over the experimental animals and dividing the resultant sum of the averages by 2.

After one hour, a yellowish discoloration of the skin was found. Discoloration held until the 9th day of the experiment at (Animal No. 4). The animals were followed up until the 10th day of the experiment.

The sum of the average stimulus values after 24 h (erythema = 1.3, edema = 0) and 72 h (erythema = 0.7, edema = 0) obtained by dividing by the number of these time points (by 2)  gave a primary irritation score of 1.0.

From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be irritating according to the E.C Commission's proposal on criteria for effects and irritants as set out in Annex VI II B 6 Directive.