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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three male and 3 female New Zealand White rabbits (obtained from H.A.R.E. Rabbits far Research, Hewitt, New Jersey) were used for this study. The rabbits weighed from 2302 to 2529 grams at the beginning of the study. They were individually housed 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" and were conditioned for a minimum of 25 days prior to study initiation. Water and Purina Rabbit Chow were available ad libitum.

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

Five hundred milligrams of the test material were applied to the back of each rabbit under a one inch square gauze patch.

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

3 male
3 female

Details on study design:

The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of 3 of the rabbits was abraded with a scalpel blade. The abrasions penetrated the stratum corneum, but were not deep enough to cause bleeding.
Five hundred milligrams of the test material were applied to the back of each rabbit under a one inch square gauze patch. The application sites were then covered with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with several layers of 75 mm Elastoplast tape. A collar was also applied. Following 24 hours of application, the bandages and collars were removed and the sites were washed with tepid tap water and examined for skin irritation. The examinations were repeated at 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hours

Score:

> 0 - < 1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: Intact skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: Intact skin

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hours

Score:

> 0 - < 1

Max. score:

1.5

Reversibility:

fully reversible

Remarks on result:

other: Abraded skin

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: Abraded skin

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: Abraded skin

Irritant / corrosive response data:

Not specified

Any other information on results incl. tables

Number of Animals Exhibiting Signs with scoring Value/Number Dosed

		Intact Skin		Abraded Skin
		Hours		Hours
Observations	Value	24	72	24	72
Erythema, Eschar Formation	0	1/3	3/3	2/3	3/3
	1	2/3		1/3
	2
	3
	4
Edema Formation	0	3/3	3/3	3/3	3/3
	1
	2
	3
	4

 

Primary Skin Irritation – Individual Rabbit Scores and Score Calculation

Intact Skin
	Erythema		Edema
	Observation Period (Hours)		Observation Period (Hours)
Animal No./Sex	24	72	24	72
33339, Male	1.0		0	0
33367, Male	0	0	0	0
33354, Female	0.5	0	0	0
Total	1.5	0	0	0
Abraded Skin
	Erythema		Edema
	Observation Period (Hours)		Observation Period (Hours)
Animal No./Sex	24	72	24	72
33813, Male	0	0	0	0
33368, Male	0	0	0	0
33376, Female	1.5	0	0	0
Total	1.5	0	0	0

Calculation for Primary Skin Irritation Score (Score = The average of all the erythema scores plus the average of all the edema score): (3.0 ÷ 12) + (0.0 ÷ 12) = 0.3

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Primary Irritation Score = 0.3

Executive summary:

Primary Irritation Score = 0.3.

Based upon the data obtained and in accordance with the require­ments of the regulations of the Federal Hazardous Substances Act, the test material would not be considered a primary skin irritant.