m-terphenyl-2'-ol

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: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

m-terphenyl-2'-ol

EC Number:

219-401-9

EC Name:

m-terphenyl-2'-ol

Cas Number:

2432-11-3

Molecular formula:

C18H14O

IUPAC Name:

3-phenyl-[1,1'-biphenyl]-2-ol

Details on test material:

- Name of the test substance used in the study report: 2,6 Diphenylphenol
- Test item No.: 10/0493-1
- Purity: 100%
- Homogeneity: homogenous on account of the high purity
- Physical state: beige solid
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cages, type III
- Diet: VRF1 (P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Reason for the vehicle: good homogeneity in olive oil Ph.Eur.
- Form of administration: suspension
- Concentration used: 40 g/100 ml

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg

DOSAGE PREPARATION:
The test item preparation was produced for each test group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. The homogeneity of the test item preparation during application was provided by stirring with a magnetic stirrer.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Individual body weight determination shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- A check for any dead or moribund animals was made at least once each workday.
- Necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with increasing concentrations over time.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: None

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.