3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted to no specified methods

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: not specified

GLP compliance:

not specified

Test type:

other: Not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol

EC Number:

216-971-0

EC Name:

3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol

Cas Number:

1709-70-2

Molecular formula:

C54H78O3

IUPAC Name:

3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Five male and 5 female rats of the Sprague-Dawley strain (obtained from Harlan Industries, Inc., Indianapolis, Indiana), weighing from 200 to 208 grams, were used for this study. The rats were housed by sex, in groups of 5 rats per cage, in hanging wire-mesh cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals". The rats were conditioned for a minimum of 5 days prior to study initiation. Water and Purina Laboratory Chow were available ad libitum, except for an overnight period of approximately 18 hours Immediately preceding oral administration during which food, but not water, was withheld.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test material was administered orally by gavage as a suspension in corn oil at the following dosage level to male and female rats: 10,000 mg/kg.
The dosage level was administered at a volume of 40 ml/kg.

Doses:

10,000 mg/kg

No. of animals per sex per dose:

5 male
5 female

Control animals:

not specified

Details on study design:

Observations for pharmacotoxic signs were recorded during the first 4 hours following dosing, at 24 hours and daily thereafter for a total of 14 days. The rats were observed for mortality during the first four hours following dosing and twice daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing (control weight) and at 7 and 14 days. All rats which died on study were subjected to gross necropsy examination as were all survivors at the end of the 14 day observation period

Statistics:

Not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

One female rat died on the first day of the 14 day study period. None of the other rats died.

Clinical signs:

other: Presented in table form, please see any otherinformation on results incl. tables.

Gross pathology:

Necropsy Findings: The following necropsy observations were obtained during the 14 day study period:
The rat (#82570) which died during the study period: Partital cannibalization, yellow stained anogenital region, stomach contains yellow creamy fluid, small intestines contain yellow creamy fluid.
Rats which were sacrificed following 14 day of observation:
No gross lesions 3/5 males, 1/4 females
Kidneys, mottled colouration 2/5 males, 3/4 females
Uterus, hydrometra 1/4 females

Other findings:

Not specified

Any other information on results incl. tables

NUMBER OF RATS SHOWING PHARMACOTOXIC SIGNS AND TIME [HOUR] (DAY) OBSERVED

	MALES	FEMALES
OBSERVATION	10,000 mg/kg	10,000 mg/kg
Normal	2 [1], 5 (2 – 14)	3 [1], 4 (2 – 14)
Hypoactivity	3 [1], 5 [2 ½, 4], 5 (1)	2 [1], 5 [2 ½, 4], 4 (1)
Death		1 (1)

 

The following body weights were obtained during the 14 day observation period

Dosage Level (mg/kg)	Individual Rat Number	Sex	Control Weight (grams)	7 Day Weight (grams)	14 Day Weight (grams)
10,000	82571	Male	202	274	328
	82572	Male	201	259	340
	82573	Male	202	225	285
	82574	Male	200	242	302
	82575	Male	204	250	280
	82566	Female	205	226	232
	82567	Female	206	258	290
	82568	Female	208	246	264
	82569	Female	202	231	235
	82570	Female	201	Died	Died

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 value was found to be greater than 10,000 mg/kg

Executive summary:

The acute oral LD50 value was found to be greater than 10,000 mg/kg