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Toxicological information

Acute Toxicity: oral

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other: In compliance with 21 CFR Part 58, available as unpublished report, no restrictions, adequate for assessment.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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Mixture of hydrogenated terphenyls
- Physical state: Yellow liquid
- Impurities (identity and concentrations): 0.15% phenyl cyclohexane and 6.79% high boilers.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
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.