Biphenyl-4-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study, pre-dating OECD guidelines, some limitations in reporting but adequate for assessment.

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

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)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

p-Phenylphenol (= p-Oxydiphenyl)

IUPAC Name:

p-Phenylphenol (= p-Oxydiphenyl)

Details on test material:

Name: p-Phenylphenol (= p-Oxydiphenyl)
Physical state: white flakes
Customer: Sparte OC
Date of order: 25/5/1979

Test animals

Species:

rat

Strain:

other: SPF rats (strain: Wistar TNO W 74)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen (Breeder)
- Age at study initiation: approximately 9 to 14 weeks old.
- Weight at study initiation: The male rats had an average initial body weight of 163 g.
- Housing: The rats were conventionally housed in groups of five in type III Macrolon cages on dust - free wood chippings
- Diet (e.g. ad libitum): During the study the rats received Altromin R 1324 (manufacturer: Altromin GmbH, Lage) ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): approximately 60 ± 5 (relative humidity)
- Photoperiod (hrs dark / hrs light): 12 - hour light/dark cycle (artificial illumination from 7.00 to 19.00)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5, males only

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least once daily
- Frequency of weighing: at the time of dosing and end of the observation period.
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No signs of toxicity and no effects on body weight gain.

Any other information on results incl. tables

- All male rats tolerated the single dose of 5 g/kg body weight without showing any symptoms.

- Bodyweight development was unaffected.

- P-Phenylphenol (= p-Oxydiphenyl) was shown to be relatively non - toxic in the acute study.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for male rats was >5000 mg/kg body weight. No symptoms of poisoning were observed.

Executive summary:

Acute toxicity studies of p-Phenylphenol (= p-<Oxydiphenyl) were conducted by oral administration in male Wistar rats.

 

The LD50 for male rats was >5000 mg/kg body weight. No symptoms of poisoning were observed.