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

Eye irritation

Administrative data

Endpoint:

eye 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 ocular 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

no data available

Duration of treatment / exposure:

no data available

Observation period (in vivo):

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

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM: DRAIZE method of scoring

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation observed

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

For the assessment of the eye irritation values, the corresponding stimulus values ​​from the DRAIZE grades were determined at the assessment times 24, 48 and 72 hours, taking into account the type, intensity and temporal course of the findings. No signs of irritation were observed in the rabbit eyes. Following the EC Guideline on the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical was to be regarded as non-irritating to the eyes.

Executive summary:

The ocular 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. The test chemical was instilled in the eyes of the rabbits and observed for signs of irritation(dose not mentioned).

The eye reactions 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.

For the assessment of the eye irritation values, the corresponding stimulus values ​​from the DRAIZE grades were determined at the assessment times 24, 48 and 72 hours, taking into account the type, intensity and temporal course of the findings. No signs of irritation were observed in the rabbit eyes. Following the EC Guideline on the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical was to be regarded as non-irritating to the eyes.