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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Data is from study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute toxicological investigations in female Wistar rats were conducted after oral administration of test chemical.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

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 (as cited in study report): [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile
- Molecular formula: C27H31N3O
- Molecular weight: 413.562 g/mol
- Substance type: Organic
- Physical state: Solid
- Designation : MACROLEX Gelb 6G = Resolinbrilliantgelb 6
- Sponsor: FB division
- Date of Order: July 12, 1978

Test animals

Species:

rat

Strain:

Wistar

Remarks:

SPF-bred Wistar rats (strain Bor: WISW (SPF Cpb)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: about 14 weeks
- Weight at study initiation: initial weight was 150 to 200 g
- Identification: The anirnals were identified by marking their coat with picric acid.
- Housing: The rats were housed in groups of five animals each under conventional conditions in Makrolon Type-I11 cages on dust-free wood granules
- Diet (e.g. ad libitum): Feed (Altromin R 1324, producer: Altromin GmbH, Lage) was also available ad libitum.
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5° C
- Humidity (%): about 60 ± 5 %.
- Photoperiod (hrs dark / hrs light): a 12-hour light/dark cycle (artificial light from 7 a.m. to 7 p.m. CET)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5000 mg/kg
- Amount of vehicle (if gavage): 30 ml/kg

DOSAGE PREPARATION (if unusual): The substance was formulated in tap water at room temperature.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 female animals

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded.
- Body weight: The animals were weighed individually at application and in groups at the end of the 14-day observation period.
- Necropsy of survivors performed: yes, the animals were sacrificed.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died.

Clinical signs:

other: No female animal showed any signs of poisoning after Single administration of 5000 mg/kg.

Gross pathology:

not specified

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral toxicity dose (LD50) value was considered to be >5000 mg/kg bw, when 10 female SPF-bred Wistar rats were treated with the given test chemical via oral gavage route.

Executive summary:

The acute oral toxicity study was conducted by using given test chemical in 10 female SPF-bred Wistar rats at the dose concentration of 5000 mg/kg bw.

The acute toxicity experiment was carried out with SPF-bred Wistar rats (strain Bor: WISW (SPF Cpb), bred by Winkelmann, Borchen, Germany). At the start of study the female rats were about 14 weeks of age; their initial weight was 150 to 200 g.

The substance was formulated in tap water at room temperature and once administered to 10 female animals at a constant application volurne of 30 ml/kg. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded. The animals were weighed individually at application and in groups at the end of the 14-day observation period. Subsequently the animals were sacrificed.

No animal died at 5000 mg/kg bw. No female animal showed any signs of poisoning after Single administration of 5000 mg/kg. Body weight development was not affected.

Under the condition of this study, the acute oral toxicity dose (LD50) value was considered to be >5000 mg/kg bw, when 10 female SPF-bred Wistar rats were treated with the given test chemical via oral gavage route.