N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-08-18 to 1987-10-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

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:

N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

EC Number:

255-473-8

EC Name:

N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Cas Number:

41642-51-7

Molecular formula:

C20H19N7O3

IUPAC Name:

N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Test material form:

solid: crystalline

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: Young adult
- Housing: one animal per cage (standard cage type III)
- Diet (e.g. ad libitum): ad libitum (ssniff K 4, Versuchtierdiäten GmbH, Soest/Westfalen, Germany)
- Water (e.g. ad libitum) ad libitum (tap water)
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): ca. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

test item moistened with water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg

Duration of treatment / exposure:

4 hours

Observation period:

7 days, irritation scores were obtained 1, 24, 48, 72 hours and 7 days after treatment

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Hansamed band-aid ´hypoallergene´ (Beiersdorf No. 2342), Fixomull-Strech Klebevlies (Beiersdorf No. 2039)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, washed with water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1, 24, 48, 72 h and 7 days

SCORING SYSTEM:
- Method of calculation: Draize (see Table 1 in box "Any other information on material and methods incl. tables")

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation were observed. For individual results see Table 2 in box "Any other information on results incl. tables".

Any other information on results incl. tables

Table 2: Individual skin irritation scores

	24 hours		48 hours		72 hours		Mean
Animal-No.	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results from an acute dermal irritation/corrosion study, conducted according to OECD 404, the test item can be considered as non-irritating to the skin. The substance is not classifiable according to CLP criteria.

Executive summary:

In a primary dermal irritation study conducted according to OECD 404, 3 male New Zealand White rabbits were dermally exposed to 0.5 g of the test item for 4 hours to an area of exposure of 6 cm² under semi-occlusive conditions. Animals were then observed for 7 days. Irritation was scored by the method of Draize. In this study, the test item is not a dermal irritant.