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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 according to sound scientific principles; similar to OECD TG 406. 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 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Generation of in vivo skin sensitization hazard data via the Buehler method pre-dated the establishment of the LLNA.

Test material

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino guinea pig
Sex:
male
Details on test animals and environmental conditions:
Temperature - 70 ± 2 degree F
Relative Humidity - 45% ± 5%
Light - 12 hour light/dark cycle
Diet - Charless River Guinea Pig Furmula and tap water are provided ad
libitum. Based on our current knowledge no contaminants were
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 5 guinea pigs/cage
Bedding - Deotized Animal Cage Board(DACB)
Shepherd Products Company
Kalamazoo, Michigan 49005

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL, 100% test material
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL, 100% test material
No. of animals per dose:
10
Details on study design:
A 0.5 mL portion of material was applied to the intact skin test site on the guinea pigs. A gauze patch was placed over the treated area and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place. After a 24 hour contact period the patch was removed and the animals were allowed to rest for one day. Following this rest period another application was applied to the same skin site using a fresh sample.

After the tenth application the animals were rested for a two week period. At the termination of the rest period a challenge application was put on skin sites differing from the original test sites. The challenge application remained on for 24 hours. The sites were examined for reaction using the Draize method of scoring to grade reactions.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 mL, 100% w/w
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL, 100% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5 mL, 100% w/w
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL, 100% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Table 1 – Individual Animal Results

 

Type of Reaction - Reading After Application (#1-10) – Challenge (24h 48h)

 

Guinea pig #1

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

 

Guinea pig #2

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

 

Guinea pig #3

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

 

Guinea pig #4

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

 

Guinea pig #5

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

 

Guinea pig #6

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

 

Guinea pig #7

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

 

Guinea pig #8

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

 

Guinea pig #9

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

 

Guinea pig #10

Erythema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Oedema - 0 0 0 0 0 0 0 0 0 0 - 0 0

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the results of this study, tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate is not a dermal sensitiser.

Classification as a dermal sensitiser 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:

A 0.5 mL portion of material was applied to the intact skin test site on the guinea pigs under an occlusive patch. After a 24 hour contact period the patch was removed and the animals were allowed to rest for one day. Following this rest period another application was applied to the same skin site using a fresh sample for 10 applications. Animals were then rested for a two week period. At the termination of the rest period a challenge application was put on skin sites differing from the original test sites. The challenge application remained on for 24 hours. The sites were examined for reaction using the Draize method of scoring to grade reactions.

Based on the results of this study, tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate is not a dermal sensitiser.

Classification as a dermal sensitiser 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.