1,1'-Biphenyl, 4-methyl-4'-(3E)-3-penten-1-yl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 26 - July 11 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

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:

473-310-0

EC Name:

-

Cas Number:

478385-88-5

Molecular formula:

C18H20

IUPAC Name:

4-methyl-4'-[(3E)-pent-3-en-1-yl]-1,1'-biphenyl

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: approx. 6 to 8 weeks
- Weight at study initiation: m: 183 - 198 g ; f: 163 - 170 g
- Fasting period before study: Diet was withheld from 17 hours before until up to 4 hours after treatment.
- Housing: The rats were kept separately in type III Makrolon cages with a shelter, placed on mobile racks. Conventional softwood granulate was used as the bedding. One day before treatment, and up to 24 hours after dosing, metal grids were placed above the softwood granulate. The cages and the metal grids had been machine-cleaned before the start of the experimental part. The bedding was changed two times per week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 23 °C
- Humidity: 45 - 65 %
- Air changes not specified, but air conditioned
- Photoperiod: 12 / 12 hrs dark / hrs light

According to the specifications given by the manufacturer, the diet, Provimi Kliba 3433.0, had been checked by independent laboratories. Analysis included qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics. The drinking water was periodically analyzed according to the regulations for human drinking water. The softwood granulate was analytically checked by independent laboratories.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

Methocel K4M Premium solution

Doses:

2000 mg/kg bw (limit test)

No. of animals per sex per dose:

3 (m) / 3 (f)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part. The behavior and general condition of all rats were monitored for at least 6 hours after administration and then checked daily.
- Necropsy of survivors performed: yes: All rats were sacrificed at the end of the experimental part by CO2-asphyxia. They were subjected to a gross pathological investigation.

Statistics:

The body weight data were recorded with a PC-program. The statistical evaluations of the body weight were carried out with a PC-program. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on tables.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed. All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw of the test material.

Gross pathology:

At necropsy no organ alterations were seen.

Other findings:

None

Any other information on results incl. tables

No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw of the test material.

All rats survived the observation period. Body weight development of the treated rats was inconspicuous. At necropsy no organ alterations were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, it is concluded, that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw following oral treatment in rats.

Executive summary:

The purpose of this assay was to provide information on possible health hazards for the test material and serve as a rational basis for risk assessment to the potential of acute oral toxicity of the test item in man. The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle.

This study was performed according to the "Acute toxic class method" (ATC). No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations. Based on the result of this study, it is concluded that the test material has no relevant acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.