3-Pyridinecarbonitrile, 4-methyl-2,6-bis[(4-methylphenyl)amino]-5-[2-[2-(trifluoromethyl)phenyl]diazenyl]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-01-15 to 2003-02-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD testing guideline and GLP compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-370-5

EC Name:

-

Cas Number:

669005-94-1

Molecular formula:

C28 H23 F3 N6

IUPAC Name:

4-methyl-2,6-bis[(4-methylphenyl)amino]-5-{2-[2-(trifluoromethyl)phenyl]diazen-1-yl}pyridine-3-carbonitrile

Details on test material:

- Description: Orange solid
- Expiry date: 01-OCT-2005
- Storage conditions: In the original container, at room temperature (range of 20 ± 3 °C), away from direct sunlight.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services; CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks; Females: 12 weeks
- Housing: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standard softwood bedding.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet ad libitum
- Water: Community tap water from Fullinsdorf ad libitum.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
- Fasting period before study: 17 to 18 hours

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30-70 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours fluorescent light/ 12 hours dark, music during the light period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

300

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.1 g/mL
- Justification for choice of vehicle: PEG 300 is a standard vehicle for studies of this type.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: For body weight: On test days 1 (prior to administration), 8 and 15. For clinical signs: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. For mortality/viability: Daily during acclimatization and twice daily during days 1 -15.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed during the course of the study.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU