Terphenyl, hydrogenated

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other: In compliance with 21 CFR Part 58, available as unpublished report, no restrictions, adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Remarks:

in compliance with 21 CFR Part 58 (FDA GLP)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Terphenyl, hydrogenated

EC Number:

262-967-7

EC Name:

Terphenyl, hydrogenated

Cas Number:

61788-32-7

Molecular formula:

C18Hn (n >18-36)

IUPAC Name:

Terphenyl, hydrogenated

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles river.
- Age at study initiation: Approximately 8 weeks (young adults).
- Weight at study initiation: 261-290 grams (males), 177-204 grams (females).
- Fasting period before study: Animals were fasted overnight prior to test material administration.
- Housing: One per cage.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: Animals quarantined for at least one week.
- Each animal was individually ear tagged. Animals randomly assign to this study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10000 mg/kg

Doses:

Single dose: 10000 mg/kg

No. of animals per sex per dose:

A single group of 5 Males, 5 Females /dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Twice daily examinations were made for mortality and signs of toxicity.
Body weights were recorded on the first day of testing and weekly thereafter.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

No deaths were seen in animals of either sex.

Clinical signs:

other: Hypoactivity, diarrhea, feces-stained fur, and urine-stained fur were observations considered to be effects of the test materials.

Gross pathology:

No abnormalities

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

LD50 > 10.000 mg/kg

Executive summary:

No deaths resulted from an oral dosage of 10.000 mg/kg body weight of Terphenyl, hydrogenated to fasted albino rats of both sexes (approximately 8 weeks old). Therefore LD50 is considered to be higher than 10.000 mg/kg body weight. Observations included hypoactivity, diarrhea, faeces-stained fur and urine-stained fur.