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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted to sound scientific principles. GLP

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Reference Type:
publication
Title:
TRIS(2-ETHYLHEXYL)BENZENE-1,2,4-TRICARBOXYLATE
Author:
OECD SIDS
Year:
2002
Bibliographic source:
SIDS Initial Assessment Report for Siam 14: TRIS(2-ETHYLHEXYL)BENZENE-1,2,4-TRICARBOXYLATE

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Source: Nouplaz TOTM(Tenneco Chemicals, Inc.)
Purity: 98.95%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Temperature - 70 ± 2 degree 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 - Techbord
Shepherd Products Company
Kalamazoo, Michigan 49005

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL 100% w/w
Duration of treatment / exposure:
24h
Observation period:
immediately after removal of patch and 48 hours later (24 and 72 hours after initial application)
Number of animals:
6 rabbits
Details on study design:
A 0.5 mL portion of material was applied to an abraded and an intact akin 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
for intact skin
Basis:
mean
Time point:
other: 24h after application
Score:
1.5
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Remarks:
for intact skin
Basis:
mean
Time point:
other: 24 h after application
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Remarks:
for intact skin
Basis:
mean
Time point:
other: 72 h after application
Score:
0.17
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h after application
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Remarks:
for abraded skin
Basis:
mean
Time point:
other: 24 h after application
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h after application
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h after application
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: Total Score
Score:
1.04
Remarks on result:
other: 4.16/4 = 1.04
Irritant / corrosive response data:
see Table 1 below

Any other information on results incl. tables

Table 1 – Individual Animal Results

 

Primary Irritation Score : 4.16/4 =1.04

 

Reading – Individual (#1-6) Rabbit Score - Average

 

Erythema and Eschar Formation (Hours)

Intact skin 24 - 2 1 2 1 2 1 – Average 1.50

Intact skin 72 - 0 0 1 0 0 0 – Average 0.17

Abraded skin 24 - 2 1 2 1 2 1 – Average 1.50

Abraded skin 72 - 0 0 1 1 0 0 – Average 0.33

Subtotal 3.50

 

Oedema Formation

Intact skin 24 - 1 0 0 0 1 0 – Average 0.33

Intact skin 72 - 0 0 0 0 0 0 – Average 0.00

Abraded skin 24 - 1 0 0 0 1 0 – Average 0.33

Abraded skin 72 - 0 0 0 0 0 0 – Average 0.00

Subtotal 0.66

 

Total 4.16

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test material is not a demal irritant to rabbits. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Dermal irritation was evaluated in a similar manner to OECD TG 404 Guideline study using 0.5 mL of tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate. The 1-48 h mean erythema score was 0.835 and the 1-48 h mean edema score was 0.165 for intact skin.

Based on the results of the study, the test material is not a demal irritant to rabbits. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.