4-(α,α-dimethylbenzyl)phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Remarks:

US EPA GLPs (40 CFR, Part 792) and OECD GLPs

Test type:

standard acute method

Limit test:

yes

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

Details on test material:

p-Cumylphenol (PCP; CAS #599-64-4), Purity = 99%;

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female New Zealand White rabbits were received from Millbrook Breeding Labs. They were 2.00 to 2.34 kg and at least 12 weeks of age. They were individually housed upon arrival in stainless steel suspended cages with hardwood chip bedding. The animals were acclimated for at least 5 days prior to dosing. Water and feed were provided ad libitum. Room temperature was 68 ± 5 degrees F and the relative humidity ranged between 30 to 70 %. Room lights were on a 12-hour light/dark cycle.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The application sites were prepared by clipping not less than 10 % of the body surface on the trunk approximately 24 hours before the application of PCP. PCP was dosed at 2000 mg/kg as received. PCP was slightly moistened and introduced under two single layer thick gauze patches and applied directly to the skin of each animal. Animals were immobilised and the patches were secured in place by wrapping the entire trunk of the animal with an impervious bandage.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

After completion of the 24-hour exposure period, the wrapping was removed and the skin was gently wiped and rinsed with water.
The animals were observed frequently during the first day and then clinical examinations were made at least once a day. The animals were also examined for signs of erythema and oedema after the exposure period as per the Draize method. Animals were weighed on Days 0 (pre-dose), 7 and 14.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed.

Clinical signs:

No overt signs of clinical toxicity were observed in any animal. No signs of erythema or oedema were observed in any animals.

Body weight:

All animals gained weight over the course of the study.

Gross pathology:

All animals were observed as normal at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

The rabbit dermal LD50 was determined to be >2000 mg/kg bw.

Executive summary:

The acute dermal toxicity was investigated in a procedure performed per OECD Test Guideline 402 and OPPTS 870.1200 under GLP conditions.

Five male and five female New Zealand White rabbits were exposed to the test material in an occlusive fashion for 24 hours at a limit dose of 2000 mg/kg.

Under the conditions of this study, the acute dermal LD50 was determined to be >2000 mg/kg bw.