p,p'-dinitrobibenzyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

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:

1,1'-ethane-1,2-diylbis(4-nitrobenzene)

EC Number:

212-001-5

Cas Number:

736-30-1

Molecular formula:

C14H12N2O4

IUPAC Name:

1,1'-ethane-1,2-diylbis(4-nitrobenzene)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Sprague-Dawley CFY
- Source: Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: males weighed 160 - 182g, females 148 - 179g
- Fasting period before study: overnight before study
- Housing: up to five by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K ad libitum
- Water: tap water ad libitum
- Acclimation period: at leat 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 55 - 68
- Air changes (per hr): approximately 15
- Photoperiod: controlled by a time switch to give 12 hours light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

DOSE LEVEL CONCENTRATION DOSE VOLUME NUMBER OF RATS
mg/kg mg/kg ml/kg MALE FEMALE

Range finding: 5000 500 10 1 1
Range finding: 2000 200 10 1 1

Main Study: 5000 500 10 5 5

Doses:

DOSE LEVEL CONCENTRATION DOSE VOLUME NUMBER OF RATS
mg/kg mg/kg ml/kg MALE FEMALE

Range finding: 5000 500 10 1 1
Range finding: 2000 200 10 1 1

Main Study: 5000 500 10 5 5

No. of animals per sex per dose:

Range finding: 1

Main Study: 5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1 and 4 hours after dosing and subsequently once daily for 14 days.
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Preliminary study:

Range finder 5000 mg/kg bw and 2000 mg/kg bw with one male and one female for each concentration. No mortality

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no deathes occured

Mortality:

no mortality occured

Clinical signs:

other: No signs of systemic toxicity were noted during the study period

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50 ) of DNBY, in the rat was found to be greater than S000 mg/kg bodyweight.
Therefore, the substance is not subject for classification for acute oral toxicity.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the rat. The study was based on the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity". For the purpose of this study the test material was ground to a fine powder using a mortar and pestle and freshly prepared, as required, at the appropriate concentrations in arachis oil B.P. All rats were dosed once only by gavage using a metal cannula attached to a graduated syringe.

A preliminary study was performed using pre-selected dose levels to determine the highest of these dose levels that produced a mortality rate of less than 50% with 5000 and 2000 mg/kg bw using one male and one female animal for each concentration.

For the main study 5 male and 5 female animals were administered with a single dose of 5000 mg/kg bw.

Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days.

No mortality occured. No signs of systemic toxicity were noted during the study period. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy of animals killed at the end of the study.