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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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

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.