(E)-3-(benzyl(4-((4-nitrophenyl)diazenyl)phenyl)amino)propanenitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 August 1998 to 25 August 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-530-4

EC Name:

-

Cas Number:

96662-24-7

Molecular formula:

Hill formula: C22H19N5O2 CAS formula: C22H19N5O2

IUPAC Name:

3-[benzyl({4-[2-(4-nitrophenyl)diazen-1-yl]phenyl})amino]propanenitrile

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKLEMANN, Gartenstr. 27, 33178 Borchen, SPF breedng colony
- Age at study initiation: 6 - 10 weeeks
- Weight at study initiation: Males - 190g, Females - 172g
- Fasting period before study: 16 hours before
- Housing: Fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil (Oleum sesami DAB 10)

Details on oral exposure:

The acute oral toxicity of T-9601 was tested only at a dose level of 2000 mg/kg body weight.
The animals received the compound as a 20 % suspension in sesame oil (Oleum sesami DAB 10), the administration volume being 10 ml/kg body weight.
If no compound-related mortality is produced in this limit test according to the guidelines no full study has to be carried out.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Males - 5
Females - 5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations twice daily (in the morning and in the afternoon), on weekends and public holidays only once. uring this time animals were weighed weekly.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No clinical signs of toxicity related to dose levels where noted during the study.

Gross pathology:

Effects on organs: No macroscopic visible changes were found.

Other findings:

Orange discoloured feces in all animals after 2 days of administration

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male & female rat is greater than 2000 mg/kg body weight.

Executive summary:

Study data conducted to EEC-Guideline B.1 of the Directive 92/68/EEC and OECD Guidleines for Testing of Chemicals 401 in compliance with GLP.

The median lethal dose value (LD50) of the substance for the male & female rat is greater than 2000 mg/kg body weight. The substance is not classified as harmful by oral exposure.