Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Qualifier:
equivalent or similar to
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
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
Statistics:
None
Positive control results:
None no positive control group on study
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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 group
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.

Induction score : 0.0

Topical challenge scores

after 24 h:0.0

After 48h :0.0

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Under the conditions of this test using the Buehler method, 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.


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

Justification for selection of skin sensitisation endpoint:
Only 1 study is available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No study is available.


Migrated from Short description of key information:
No study is available.

Justification for classification or non-classification

The above study has been ranked reliability 2 according to the Klimisch et al system. This ranking was deemed appropriate because the study was conducted to GLP and in compliance with recognised test methods. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

By read-across, the above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008).