p-(1,1-dimethylpropyl)phenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-07-02 to 1992-07-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

p-(1,1-dimethylpropyl)phenol

EC Number:

201-280-9

EC Name:

p-(1,1-dimethylpropyl)phenol

Cas Number:

80-46-6

Molecular formula:

C11H16O

IUPAC Name:

4-(2-methylbutan-2-yl)phenol

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): phenol, 4-(1,1-dimethylpropyl)-
- Lot/batch No.: 20409018

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female Sprague-Dawley strain rats were supplied by Charles River (UK) Ltd., Manston, Kent, U.K. At the start of the main study the males
weighed 151 - 165g, and the females 149 - 170g, and were approximately five to eight weeks old.
The animals were housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding. With the exception of an overnight
fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse
Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 20 - 22·C and relative humidity of 60 - 76%. On occasions the relative humidity was above the
limit specified in the protocol (70%). This was considered not to have affected the purpose or integrity of the study. The rate of air exchange was
approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each
animal was calculated according to its fasted bodyweight at the time of dosing.
10 ml/kg of a 200 mg/ml concentration of suspension was dosed.

Doses:

2000mg/kg

No. of animals per sex per dose:

Range finding study n=1 male, n=1 female.
Main study n=5 males, n=5 females.

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths

Clinical signs:

other: No signs of systemic toxicity were noted during the study

Gross pathology:

No abnormalities were noted at necropsy

Any other information on results incl. tables

Nothing to report

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 >2000mg/kg

Executive summary:

In an oral acute toxicity range finding study, P-tert amyl phenol was administered to 5 males/5 female Sprague Dawley rats by oral gavage at a dose level of 2000 mg/kg bw/day. There were no deaths and no signs of toxicity in this study. The LD50 was >2000 mg/kg/day.