[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-10-25 to 1982-11-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium chloride

EC Number:

259-033-6

EC Name:

[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium chloride

Cas Number:

54229-13-9

Molecular formula:

C21H29ClN5O3.Cl

IUPAC Name:

[2-({4-[(E)-2-(2-chloro-4-nitrophenyl)diazen-1-yl]phenyl}(ethyl)amino)ethyl](2-hydroxypropyl)dimethylazanium chloride

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hagemann GmbH & Co. KG, Extertal, Germany
- Age at study initiation: no data
- Weight at study initiation: mean weight of 2.8 kg
- Housing: one animal per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours, 8 days

Number of animals:

three male rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- % coverage: full
- Type of wrap if used: elastic adhesive dressing "Eloflex"

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water or olive oil
- Time after start of exposure:4 hours

SCORING SYSTEM: Draize
Erythema and eschar formation:
0 - No erythrema
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation:
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well-defined by definite raising)
3 - Moderate oedema (raised approximately 1 millimetre)
4 - Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable because of methodological limitations

Remarks:

No erythema scores were awarded due to colouration of the skin by the test substance.

Irritant / corrosive response data:

The indiviual scores are presented in Table 1 (see box "Any other information on results incl. tables"). No erythema scores according to Draize were awarded due to colouration of the skin by the test substance. But, it was stated by the study director that no irritating effects were observed.

Any other information on results incl. tables

Table 1: Summary of results
		Draize score
Animal number		1h		24h		48h		72h		8d
		E	O	E	O	E	O	E	O	E	O
1		x	1	x	0	x	0	x	0	x	0
2		x	1	x	0	x	0	x	0	x	0
3		x	1	x	0	x	0	x	0	x	0

E= erythema, O= edema

x= no scores awarded due to colouration of the skin

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal irritation/corrosion study according to OECD 404 the test item is considered to be non-irritating to the skin.

Executive summary:

In a primary dermal irritation study (OECD 404), three male New Zealand White rabbits were dermally exposed to 0.5 g of the test item (84% purity) for 4 hours to an area of exposure of 2.5 x 2.5 cm² under semi-occlusive conditions. Animals then were observed for 8 days. Irritation was scored by the method of Draize. In this study, the test item is not a dermal irritant.