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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
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.