[1,1'-Biphenyl]-2-carbonitrile, 4'-(bromomethyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 15 September 1994 to 29 september 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to international guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4'-(bromomethyl)-[1,1'-biphenyl]-2-carbonitrile

EC Number:

601-327-7

Cas Number:

114772-54-2

Molecular formula:

C14H10BrN

IUPAC Name:

4'-(bromomethyl)-[1,1'-biphenyl]-2-carbonitrile

Details on test material:

SR 48941
Batch 4SNP006

Test animals

Species:

rat

Strain:

other: OFA-SD (IOPS Caw)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Each group was composed of 5 animals of the sale sex. Animals were subjected to clinical examination and selected if they were in good health. The animals were assigned manually to the experimental group and identified by tattoo according to the Standard Operating Procedures.
- Source: Iffa Credo
- Age at study initiation: approximately 5 weeks old
- Weight at study initiation: 135 to 153 grams for males and 119 to 135 grams for females.
- Housing: Rats were housed 2 or 3 of the same group to stainless steel cages (891 cm² x 18 cm).
- Diet (e.g. ad libitum):free access to UAR AO4C. Food was withdrawn 18 hours before treatment and redistributed approximatly 4 hours after gavage.
- Water (e.g. ad libitum): tap water
- Acclimation: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (+/- 2°C)
- Relative Humidity (%): 40-70 %
- Air changes (per hr): air was renewed 10 to 11 times per hour without recycling.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.6% methylcellulose aqueous solution

Doses:

0 and 2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females per group

Control animals:

yes

Details on study design:

Animals were kept under observation for 15 days following administration. During this period, clinical signs and cases of mortality were recorded.
A study of body weight changes was performed by weighing the animals on the day of treatment (D1), then on D3, D8 and D15.
Post-mortem macroscopic examination was performed in the animals found dead during the study. Lethal dose values were calculated, when possible, after mortality 15 days following treatment.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality recorded

Clinical signs:

other: No abnormality detected

Gross pathology:

No abnormality detected

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dose level of 2000 mg/kg was non lethal (with LD50 > 2000 mg/kg), and did not induce adverse effects in rats of either sex.