4-(α,α-dimethylbenzyl)phenol

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA TSCA 40 CFR 798.1175

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-(α,α-dimethylbenzyl)phenol

EC Number:

209-968-0

EC Name:

4-(α,α-dimethylbenzyl)phenol

Cas Number:

599-64-4

Molecular formula:

C15H16O

IUPAC Name:

4-(α,α-dimethylbenzyl)phenol

Constituent 2

Reference substance name:

290-968-0

IUPAC Name:

290-968-0

Details on test material:

- Name of test material: para-Cumylphenol, (PCP, CAS #599-64-4)
- Physical state: solid
- Storage condition of test material: After mixing, the test material was transferred to five small, clear colorless glass vials with beige plastic caps. A separate vial will be used to prepare each dose level. All aliquots were stored at room temperature.
- Purity not stated.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animals were purchased from a USDS approved supplier, Harlan Sprague-Dawley, Inc.
- Age at study initiation: young adult
- Weight at study initiation: 220 to 357 grams
- Fasting period before study: Food withheld overnight prior to dosing.
- Housing: Housed in groups of two in wire mesh suspension cages.
- Diet: Purina laboratory rodent chow, or other comparable diet, provided ad libitum.
- Water: Tap water ad libitum.
- Acclimation period: All animals were acclimated to the laboratory for at least four days before being used.

ENVIRONMENTAL CONDITIONS
- Photoperiod: The animals were maintained on a 12-hour light/12-hour dark cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test material was administered as a 25 % w/v formulation in corn oil to groups of male and female young adult Sprague Dawley rats.

Doses:

5.0, 2.5, 1.25 and 0.625 g/kg

No. of animals per sex per dose:

Two male and two female young adult Sprague Dawley rats were used per dose group.

Control animals:

no

Details on study design:

Animals were observed several times on the dose day and at least twice daily for 14 days post-dose. Body weights were measured and a gross necropsy was performed on all animals.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 770 mg/kg bw

Mortality:

At the 5.0 g/kg dose level, one male and two females died one day after treatment and the second male died day two post dose. At the 2.5 g/kg dose level, one female died one day post dose, one male died day 3 post dose, and the remaining male and female animals died by day 7 post dose. No deaths were recorded at 1.25 g/kg or lower.

Gross pathology:

Mottled liver and spleen, congested kidneys, distended stomach, darkened intestine filled with red fluid, bright red coloured lungs and blackened spleen were observed at the 5.0 g/kg dose level. Mottled liver and spleen, congested kidneys, distended stomach and reddened and transparent intestines were observed at the 2.5 g/kg dose level. No abnormal gross pathology was noted in animals of the 1.25 g/kg or 0.625 g/kg dose groups.

Any other information on results incl. tables

One male and one female died day 1 post dose at the 1.25 g/kg dose level, however, data from this dose group was replaced with a second 1.25 g/kg dose level due to erroneous sacrificing on day 11 of surviving animals in the first group. Only data from the second dose group at 1.25 g/kg with observations to the completion of the observation period were used to calculate the LD50.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of this study, the acute oral LD50 was 1770 mg/kg.

Executive summary:

The acute oral toxicity was investigated in a fixed dose procedure performed per EPA TSCA 40 CFR 798.1175 under GLP conditions.

The test material was administered as a 25 % w/v formulation in corn oil to groups of male and female young adult Sprague Dawley rats at dose levels of 5.0, 2.5, 1.25, and 0.625 g/kg (two rats per sex per dose).

Under the conditions of this study, the acute oral LD50 was 1770 mg/kg.