4,4'-isopropylidenedi-o-cresol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Oct - 22 Nov 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: MHW guideline (Yakushin No. 118, 1984)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-isopropylidenedi-o-cresol

EC Number:

201-240-0

EC Name:

4,4'-isopropylidenedi-o-cresol

Cas Number:

79-97-0

Molecular formula:

C17H20O2

IUPAC Name:

4,4'-isopropylidenedi-o-cresol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan, Inc, Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 127 - 130 g (males); 97 - 109 g (females)
- Fasting period before study: yes, overnight
- Housing: 5 rats per cage were housed in polycarbonate cages (265W x 426D x 200Hmm, Tokiwa Kagaku Kikai Co., Ltd.) with bedding (Beta chip, Charles River Japan, Inc.) for laboratory animals . The cages were stored in rat cage rack of 4 rows (Tokiwa Kagaku Kikai Co., Ltd.). The cages (including bedding), stainless feeder for pellet food (Tokiwa Kagaku Kikai Co., Ltd.) and polycarbonate water-dispensing bottle (500 mL: Tokiwa Kagaku Kikai Co., Ltd.) were changed every week with autoclaved ones.
- Diet: pellet food for laboratory animals (MF, Oriental Yeast Co., Ltd.), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): about 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 Nov 1988 To: 22 Nov 1988

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for signs of toxicity 30 min, 1, 3 and 6 h after administration and thereafter once daily up to the end of the observation period. Body weights were recorded prior to administration, and on Days 3, 7 and 14.
- Necropsy of survivors performed: Yes, all animals were sacrificed by excessive bleeding from the vetral aorta under anesthesia with sodium pentobarbital.

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:

No mortality occurred during the study period.

Clinical signs:

other: A gait anomaly was seen in 1/5 males 30 min after the test substance administration, which diminished within 3 hours after the administration.

Gross pathology:

A red spot was seen in the lung of 1/5 males. The change was considered to be incidentally, since the change was minimal and not observed in the treated females.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008