[1,1'-Biphenyl]-2,2'-diol, 3,3',5,5'-tetramethyl-

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 guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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:

3,3',5,5'-tetramethyl-[1,1'-biphenyl]-2,2'-diol

EC Number:

607-957-9

Cas Number:

26567-10-2

Molecular formula:

C16 H18 O2

IUPAC Name:

3,3',5,5'-tetramethyl-[1,1'-biphenyl]-2,2'-diol

Test animals

Species:

rat

Strain:

other: RccHan:WIST rats

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9 weeks at test item administration
- Weight at study initiation: females 167 – 175 g
- Fasting period before study: overnight
- Housing: 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 13 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): BCBJ7623V (Sigma-Aldrich Kft.)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily thereafter
- Frequency of weighing: Body weight was measured on Days -1, 0 and 7 and Day 14
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to a necropsy and a macroscopic examination.

Results and discussion

Preliminary study:

In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The substance did not cause mortality at the dose level of 2000 mg/kg bw.

Clinical signs:

other: Decreased activity (4/6), hunched back (3/6), incoordination (score1) (2/6) and faeces liquid (3/6). All animals became symptom free from Day 4 until at the end of the observation period.

Gross pathology:

There was no evidence of macroscopic observations at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female RccHan:WIST rats.