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

Endpoint summary

Description of key information

Both studies performed to no specified methods, however written with clear and concise study plans. 
Not irritating to the skin or eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: not specified

GLP compliance:

not specified

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.

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.

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: Intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: Intact skin

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: Abraded skin

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: Not specified

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three male and 3 female New Zealand White rabbits (obtained from H.A.R.E. Rabbits for Research, Hewitt, New Jersey) were used for this study. The rabbits weighed from 2300 to 2813 grams at the beginning of the study. The rabbits 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 "Ose of Laboratory Animals". The animals were conditioned for a period of 20 days prior to study initiation. Water and Purina Rabbit Chow were available ad libitum.

Vehicle:

not specified

Controls:

other: left eye untreated

Amount / concentration applied:

The rabbits received 100 milligrams of the test material

Duration of treatment / exposure:

Not specified

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 males
3 females

Details on study design:

Prior to test material administration, the eyes of each rabbit were examined with ultraviolet light following instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.
The rabbits received 100 milligrams of the test material. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Max. score:

0

Remarks on result:

other: Opacity

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 hours

Score:

> 0 - < 1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Opacity

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 48, 72 hours & 7 days

Score:

0

Max. score:

0

Remarks on result:

other: Opacity

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Max. score:

0

Remarks on result:

other: Area

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 hours

Score:

> 0 - < 1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: Area

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 48, 72 hours & 7 days

Score:

0

Max. score:

0

Remarks on result:

other: Area

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 hour

Score:

> 0 - < 1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 hours

Score:

> 0 - < 1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 48, 72 hours & 7 days

Score:

0

Max. score:

0

Remarks on result:

other: Irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

> 1 - < 2

Max. score:

1.5

Reversibility:

fully reversible

Remarks on result:

other: Redness

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

> 1 - < 2

Max. score:

2.5

Reversibility:

fully reversible

Remarks on result:

other: Redness

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 hours

Score:

> 0 - < 1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Redness

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

> 0 - < 1

Max. score:

0.5

Reversibility:

fully reversible

Remarks on result:

other: Redness

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

0

Remarks on result:

other: Redness

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 hour

Score:

> 1 - < 2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 hours

Score:

> 0 - < 1

Max. score:

1.5

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 48 hours

Score:

> 0 - < 1

Max. score:

0.5

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 hours & 7 days

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

> 1 - < 2

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: Discharge

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

> 0 - < 1

Max. score:

1.5

Reversibility:

fully reversible

Remarks on result:

other: Discharge

Irritant / corrosive response data:

Not specified

Primary Eye Irritation Study in the Albino Rabbit – Group Observations

	Observations		Examination Interval (No. Positive/No. Dosed)
			Hours				Day
			1	24	48	72	7
DRAIZE SCORING VALUES
Cornea	Cornea Normal		6/6	3/6	5/6	6/6	6/6
	Dulling Normal Corneal Luster			2/6	1/6
	Corneal Opacity	Very slight		1/6
		Slight
		Moderate
		Marked
Iris	Iris Normal		5/6	4/6	6/6	6/6	6/6
	Iridal Irritation		1/6	2/6
Conjunctivae	Redness	Normal			2/6	5/6	6/6
		Very slight		3/6	2/6	1/6
		Slight	6/6	2/6	2/6
		Moderate		1/6
		Marked
	Chemosis	Normal	1/6	2/6	5/6	6/6	6/6
		Very slight	4/6	4/6	1/6
		Slight	1/6
		Moderate
		Marked
	Discharge	Normal		5/6	6/6	6/6	6/6
		Very slight	1/6
		Slight	4/6	1/6
		Moderate	1/6
		Marked
SODIUM FLUORESCENT/ULTRA-VIOLET LIGHT EXAMINATION
	Negative (normal)		---	---	---	6/6	6/6
	Positive (corneal injury)		---	---	---	0/6	0/6
OTHER FINDINGS
Clear discharge			6/6	1/6	0/6	0/6	0/6
Blanching, conjunctivae			3/6	0/6	0/6	0/6	0/6

 

Primary Eye Irritation Study in the Albino Rabbit – Group Average Scores

Area		Average Scores (Range)
		Period
		Hours				Day
		1	24	48	72	7
Cornea	A	0	0.2 (0 – 1.0)	0	0	0
	B	0	0.5 (0 – 3.0	0	0	0
	Score	0	0.5	0	0	0
Iris	A	0.2 (0 – 1.0)	0.3 (0 – 1.0)	0	0	0
	Score	1.0	1.5	0	0	0
Conjunctivae	A	1.1 (1.0 – 1.5)	1.1 (0 – 2.5)	0.5 (0 – 1.0)	0.1 (0 – 0.5)	0
	B	1.0 (0 – 2.0)	0.7 (0 – 1.5)	0.1 (0 – 0.5)	0	0
	C	1.3 (0.5 – 2.0)	0.3 (0 – 1.5)	0	0	0
	Score	6.8	4.2	1.2	0.2	0
	Total scores	7.8	6.2	1.2	0.2	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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 eye irritant

Executive summary:

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 eye irritant

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Study written with clear and concise study plan.

Justification for selection of eye irritation endpoint:
Study written with clear and concise study plan