Trihexyl benzene-1,2,4-tricarboxylate

Skin sensitisation

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Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

Buehler Test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

predates REACH regulation and subsequent related regulations concerning preference for LLNA for in vivo testing

Test material

Test material information

Constituent 1

Specific details on test material used for the study:

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 - Deodorized Animal Cage Board (DACB)
Shepherd Products Company
Kalamazoo, Michigan 49005

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.5 mL

Day(s)/duration:

1

Induction 2

Route:

epicutaneous, open

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.5 mL

Day(s)/duration:

1

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Day(s)/duration:

1

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.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

other: Readings 1-10

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 mL/induction

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None

Results 2

Key result

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 ml

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None

Results 3

Key result

Reading:

rechallenge

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5 ml

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was evaluated for skin sensitisation potential according to OECD Guideline 406 using a Buehler Test on guinea pigs. The test substance did not produce skin sensitisation in any animal. Classification criteria are not met.