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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1984 to 1985-04-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

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 acetate

EC Number:

279-919-6

EC Name:

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

Cas Number:

82205-20-7

Molecular formula:

C21H29ClN5O3.C2H3O2

IUPAC Name:

N-{2-[{4-[(2-chloro-4-nitrophenyl)diazenyl]phenyl}(ethyl)amino]ethyl}-2-hydroxy-N,N-dimethylpropan-1-aminium acetate

Test material form:

liquid

Details on test material:

see below

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)
- Housing: one animal per cage under standardized conditions
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours; 7 and 14 days

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- % coverage: full
- Type of wrap if used: covered with an elastic adhesive, air-permeable bandage

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

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

not determinable

Remarks:

Due to colouration of the skin by the test substance the evaluation was difficult.

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 primary irritating effects were observed.

Any other information on results incl. tables

Table 1: Summary of results

Draize score

Animal number

Body weight

1h

24h

48h

72h

7d

14d

E

O

E

O

E

O

E

O

E

O

E

O

10

3.9 kg

x

0

x

0

x

0

x

0

x

0

-

-

11

3.2 kg

x

0

x

0

x

0

x

0

x

0

-

-

12

3.6 kg

x

0

x

0

x

0

x

0

x

0

-

-

E= erythema, O= edema

-= no evaluation

x= not assessbale due to colouration by the test substance

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 mL of the test item (target substance content: 57.2%) for 4 hours to an area of exposure of 2.5 x 2.5 cm² under semi-occlusive conditions. Animals then were observed for 14 days. Irritation was scored by the method of Draize. In this study, the test item is not a dermal irritant.