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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 22 - April 25 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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

Justification for non-LLNA method:

Study undertaken prior to the introduction of the LLNA (OECD TG 429 originally adopted April 2002)

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

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

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

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

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

Positive control results:

None no positive control group on study

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.

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.

Group:

negative control

Remarks on result:

not measured/tested

Group:

positive control

Remarks on result:

not measured/tested

Induction score : 0.0

Topical challenge scores

after 24 h:0.0

After 48h :0.0

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this test 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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Delayed dermal sensitisation has been assessed in the guinea pig using the Buehler method. No sensitisation response was reported at challenge following a period of induction exposures to the substance.

In addition, the potential sensitizing effects of a number of plasticizers, including TOTM, has been examined in a human repeated insult patch test. The substances were judjed to be non-sensitizers based on the criteria established by the FDA for sensitization of human subjects

Migrated from Short description of key information:
Skin sensitisation: Not sensitising

Justification for selection of skin sensitisation endpoint:
Best documented of the available studies

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No sensitisation response was reported at challenge following a period of induction exposures to the substance in both animal and human models.