Triisodecyl benzene-1,2,4-tricarboxylate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

22 March - 25 April 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted in accordance with recognised test methods

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:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

- reduced numbers of animals used (10 rather than 20 in test group), no control animals

Principles of method if other than guideline:

Ten male guinea pigs, weighing 300-400 g were used to assess the contact dermal irritation/sensitisation potential of Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM. The animals were housed & maintained in compliance with the animal welfare act (Pub. L-94-279) 9CFR part 3. ). TOTM was applied to intact skin sites and left in contact for 24h. TOTM was applied a second time on the same sites on day 3 and the sequence was repeated for a total of 10 applications. The animals were untreated for 2 weeks after which a challenge dose was applied to new skin sites for 24h . Twenty -four h after each application in the induction phase and 24 & 48h after the challenge application the sites were examined for signs of irritation and any findings scored using the Draize method.

GLP compliance:

yes

Type of study:

Buehler test

Test material

Test material information

Constituent 1

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

IUPAC Name:

tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

Details on test material:

- Name of test material (as cited in study report): Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM
Used as supplied

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: albino

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: Not reported
- Weight at study initiation: 300-400 g
- Housing: Stainless steel cages with elevated wire mesh flooring
- Diet (e.g. ad libitum): ad libitum, Charles River Guinea pig Formula,
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 +/-2 degrees F
- Humidity (%): 45+/-5
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: From: 21 September To: 28 October 1981

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

Induction phase: neat Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM
Challenge phase: Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

Induction phase: neat Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM
Challenge phase: Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM

No. of animals per dose:

10

Details on study design:

RANGE FINDING TESTS: No data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24 h
- Test groups: 1
- Control group: 0 (none)
- Site: Not specified
- Frequency of applications: 10 with a 24h recovery period between them
- Duration: Until Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM had been applied 10 times
- Concentrations: 0.5 ml of 100%/neat TOTM

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after 10th sensitising/induction application
- Exposure period: 24 h
- Test groups: 1
- Control group: 0 (none)
- Site: No data
- Concentrations: 100%, used as supplied
- Evaluation (hr after challenge): 24 & 48h

OTHER:

Challenge controls:

None used

Positive control substance(s):

no

Study design: in vivo (LLNA)

Statistics:

None

Results and discussion

Positive control results:

None no positive control group on study

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100% TOTM

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No data

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% TOTM. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100% TOTM

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No data

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% TOTM. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.

Any other information on results incl. tables

Induction score : 0.0

Topical challenge scores

after 24 h:0.0

After 48h :0.0

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, is not a primary irritant, fatiguing agent or skin sensitiser in the albino guinea pig. No skin reactions were seen during the induction (sensitising) phase or subsequent challenge phase.

Executive summary:

Delayed dermal sensitisation has been assessed using the Buehler method.

No sensitisation response was reported at challenge following a period of induction exposures to the substance