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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
21 Sep - 28 Oct 1981
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Study meets basic scientific principles. However, no range-finding study was performed. No positive and negative controls were included in the study.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981
Reference Type:
secondary source
Title:
TRIS(2-ETHYLHEXYL)BENZENE-1,2,4-TRICARBOXYLATE CAS N°: 3319-31-1
Author:
OECD
Year:
2002
Bibliographic source:
UNEP publications

Materials and methods

Principles of method if other than guideline:
The test was performed according to the Modified Buehler method as described in Buehler, E.V. (1965). Delayed contact hypersensitivity in the guinea pig. Arch. Dermatol., 91, 171. A 24-hour covered contact with 0.5 mL of the neat test substance was repeated on 10 consecutive days. After a resting period of 2 weeks, a challenge application with 0.5 mL of the neat test substance was performed for 24 h. Scoring of skin reactions according to Draize was performed 24 h after induction application as well as 24 and 48 h after challenge application.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Data were developed prior to the LLNA method becoming the preferred method for the in-vivo assessment of sensitisation.

Test material

Constituent 1
Chemical structure
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
Molecular formula:
C33H54O6
IUPAC Name:
tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 300-400 g
- Housing: animals were housed in groups of 5 in stainless steel cages with mesh flooring and bedding material Deotized Animal Cage Board (DACB) (Shepherd Products Company, Kalamazoo, USA).
- Diet: Charles River Guinea Pig Formula, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 21 °C
- Humidity (%): 45 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted (0.5 mL)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted (0.5 mL)
No. of animals per dose:
10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24 h
- Test groups: undiluted test substance
- Site: test site on the trunk
- Frequency of applications: every 24 h
- Duration: Days 1-10
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 24
- Exposure period: 24 h
- Test groups: undiluted test substance
- Site: skin site different from original site
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after challenge
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Group:
negative control
Remarks on result:
not measured/tested
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
CLP: not classified