[[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

data is from experimental reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the dermal irritation potential of the test chemical in New Zealand White rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

[[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile

EC Number:

258-964-5

EC Name:

[[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile

Cas Number:

54079-53-7

Molecular formula:

C27H31N3O

IUPAC Name:

2-[(4-{[2-(4-cyclohexylphenoxy)ethyl](ethyl)amino}-2-methylphenyl)methylidene]propanedinitrile

Test material form:

solid

Details on test material:

- Name of test material : Macrolex Yellow 6G
- IUPAC name : (4-{[2-(4-cyclohexylphenoxy)ethyl](ethyl)amino}-2-methylbenzylidene)malononitrile / Solvent Yellow 179
- Molecular formula): C27H31N3O
- Molecular weight :413.562 g/mol
- Smiles notation : N#C\C(C#N)=C/c1c(cc(N(CCOc2ccc(cc2)C2CCCCC2)CC)cc1)C
- InChl: 1S/C27H31N3O/c1-3-30(26-12-9-25(21(2)17-26)18-22(19-28)20-29)15-16-31-27-13-10-24(11-14-27)23-7-5-4-6-8-23/h9-14,17-18,23H,3-8,15-16H2,1-2H3
- Substance type:Organic
- Physical state:Solid
- Storage : room temperature
- Expiry date : 2009-11-01
- Empirical formula : C27 H31 N3 O
- Water solubility : < 0.0007 mg/L
- Log KOW : 7.88 (moddeled data)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: male and female
- Source: no data available
- Age at study initiation:
- Weight at study initiation: 2.5 to 3.4 kg
- Housing: The animals were conventionally kept in single cages under standardized conditions
- Diet (e.g. ad libitum): The diet consisted of a standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period:no data available

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

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

24 hours

Observation period:

0,24,48,72hours, 7 and 14 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: back of the ear
- % coverage: no data available
- Type of wrap if used: plaster bandages

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:test sample was washed off with soap and water

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 0, 24,48, 72 hours and 7, 14 days

SCORING SYSTEM:
- Method of calculation: The numerical recording of the effects was made by DRAIZE.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

14 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

14 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

no erythema or edema observed

Any other information on results incl. tables

Table 1: The animal-specific skin reactions and the skin irritation values are as follows:

Rabbit number	Draize-grade after approximately												stimulus value
	0		24		48		72		7		14		E	(ed)
	E	(ed)	E	(ed)	E	(ed)	E	(ed)	E	(ed)	E	(ed)
53	0	0	0	0	0	0	0	0	0	0	N	N	0	0
47	0	0	0	0	0	0	0	0	0	0	N	N	0	0

E = erythema / scab; (ED) = edema; N = no assessment

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The primary skin irritant / Corrosion effects was on rabbits (Inner surface of the ears) tested. The overall score for erythema and edema formation after 7 days was 0.0 Following the EC Guideline for the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical can to be considered as non-irritating to the skin.

Executive summary:

The dermal irritation potential of the test chemical was assessed in New Zealand White rabbits.2 Albino rabbits (white New Zealand) of both sexes were used with a body weight of about 2.5 to 3.4 kg. The animals were conventionally kept in single cages under standardized conditions.

For the treatment of each animal, 0.5 g of the test sample was applied to a pulp pad and fixed to the hairless inside of a rabbit of 2 rabbits by means of plaster bandages. To better support the patch, a Stilck pulp was formed into a roll and tied into the ear. The exposure duration was 24 hours. Then the test sample was washed off with soap and water. Erythema and edema were observed and scored at 0, 24,48, 72 hours and 7, 14 days. The numerical recording of the effects was made according to DRAIZE.

The primary skin irritant / Corrosion effects was on rabbits (Inner surface of the ears) tested. The overall score for erythema and edema formation after 7 days was 0.0 Following the EC Guideline for the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical can to be considered as non-irritating to the skin.