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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-09-04 - 1981-09-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Section 1500.3 Federal Hazardous Substances Act Regulations - 16 CFR P. 124.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
EC Number:
222-020-0
EC Name:
Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
Cas Number:
3319-31-1
Molecular formula:
C33H54O6
IUPAC Name:
tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
Details on test material:
Tris(2-ethoxyhexyl)trimellitate (CAS 3319-31-1): 98.95 %
2-Ethylhexanol: 0.5 %
Miescellaneous Esters: 1.00 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Husbandry Conditions:
Temperature: 70°F + /-2°F
Relative Humidity: 45% +/- 5%
Light: 12 hour light/dark cycle
Diet: Wayne 15% Rabbit Ration and tap water are provided ad libitum. Based on our current knowledge no contaminants are known to be in this diet or water that might be expected to interfere with the objectives of the study.
Caging: Stainless steel with elevated wire mesh flooring 1 rabbit/cage
Bedding: Techboard Shepherd Products Company Kalamazoo, Michigan 49005

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL portion, used as supplied
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
The sample was dosed as supplied.
One group of six New Zealand White rabbits was clipped over a wide area. One side of the animals' backs war-abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact.
A 0.5 ml portion of material was applied to an abraded and an intact skin site on the same rabbit. Gauze patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place.
The wrapping was removed at the end of the twenty-four hour period and the treated areas were examined. Readings were also made after seventy-two hours. The Draize method of scoring was employed.After 24h the wrapping was removed, patches taken off and the treated areas examined for skin reactions. Observations were also made at 72 h. On both occasions the observations were graded as stated above.



DRAIZE SCALE: GRADING OF SKIN REACTIONS
Erythema and Eschar Formation
No erythema ......................................................................... ..................................................0
Very slight erythema (barely perceptible) ..............................................................................1
Well defined erythema ............................................................................................................ 2
Moderate to severe erythema   ...............................................................................................3
Severe erythema (beef redness) to slight eschar formation (injuries in depth)................. 4
 
Oedema Formation
No edema....................................................................................................................................0
Very slight oedema (barely perceptible) ..................................................................................1
Slight oedema (edges of area well defined by definite raising) ............................................2
Moderate oedema (raised approximately 1 mm) ....................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) ..........4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin, 6 rabbits
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin, 6 rabbits
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin, 6 rabbits
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin, 6 rabbits
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
1.04
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact and abraded skin
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact and abraded skin
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact and abraded skin
Time point:
24 h
Score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact and abraded skin
Time point:
72 h
Score:
1
Reversibility:
not fully reversible within: 72 h
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact and abraded skin
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 h for intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact and abraded skin
Time point:
72 h
Score:
>= 0 - <= 1
Reversibility:
fully reversible within: 72 h for intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact and abraded skin
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact and abraded skin
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
intact and abraded skin
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
intact and abraded skin
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
intact and abraded skin
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
intact and abraded skin
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
intact and abraded skin
Time point:
24 h
Score:
1
Reversibility:
fully reversible within:
Remarks:
72 h
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
intact and abraded skin
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
intact and abraded skin
Time point:
48 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Irritant / corrosive response data:
Produced slight to well defined erythema when applied to the intact skin of rabbits. Recovery generally occurred within 72h.
Other effects:
not specified

Any other information on results incl. tables

Table 1 Primary Skin irritation

 Erythema and Eschar Formation     Reading (Hours)     Rabbit Number  Average
 1  2  3  4  5  6  
 Intact Skin  24  2  1  2  1  2  1  1.50
 Intact Skin  72  0  0  2  0  0  0  0.17
 Abraded Skin  24  2  1  2  1  2  1  1.50
 Abraded Skin 72   0  0  1  1  0  0  0.33
  Subtotal  3.50
 Edema Formation                
 Intact Skin  24  1  0  0  0  1  0  0.33
 Intact Skin  72  0  0  0  0  0  0  0
 Abraded Skin  24  1  0  0  0  1  0  0.33
 Abraded Skin  72  0  0  0  0  0  0  0
  Subtotal  0.66
  Total  4.16
 Primary irritation Score: 4.16 / 4 = 1.04                        

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS (CLP) criteria not met
Conclusions:
Based on the data, the subject material would not be classified as a primary skin irritant to albino rabbits within the definition of the Act-Reference: Section 1500.3 (c) (4) and requires no cautionary labeling with respect to that section.
Executive summary:

The in vivo test method on acute dermal irritation was similar to Section 1500.41. Federal Hazardous Substances Act Regulations - 16 CFR and in compliance with GLP criteria.

During exposure to 0.5 mL of the neat material, held covered contact with the abraded and unabraded skin of 6 rabbits, of 24 hours rabbits were tested for acute dermal irritation. The primary irritation score of 1.04 would be equivalent to a classification (<2) of mildly irritant (Draize, 1944). This report concluded that tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate was not a primary skin irritant in rabbits.

Based on the data, the subject material would not be classified as a primary skin irritant to albino rabbits within the definition of the Act-Reference: Section 1500.3 (c) (4) and requires no cautionary labeling with respect to that section.