Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 23 - November 04 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Insecticide, fungicide & rodenticide Act part 163, Title 40; Code of the federal Regulations 40 CRF 163.81 & Principles & procedures for evaluating the toxicity of household substances Publication 1138, National Academy of Sciences-National Resear
GLP compliance:
yes
Test type:
other: Limit Test
Limit test:
yes

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
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Nuoplaz 6959 (Tris (2-ethylhexyl)trimellitate)
- Physical state: liquid
- Analytical purity: 98.95%
- Impurities (identity and concentrations): 2-ethylhexanol 0.05%, miscellaneous esters 1.00%
- Composition of test material, percentage of components: Tris (2-ethylhexyl)trimellitate, 2-ethylhexanol 0.05%, miscellaneous esters 1.00%
- Lot/batch No.: 39049

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Becker Centalia Kansas USA
- Weight at study initiation: 2.3-3.2 Kg
IN-LIFE DATES: From: October 22 To: November 04

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back with longitudinal abrasions over the exposure area. Abrasions penetrated the stratum corneum but not deeply enough to cause bleeding
- % coverage: 10
- Type of wrap if used: gauze covered by rubber dam

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes area wiped
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 ml/kg
- Concentration (if solution): 100% (as supplied)
- Constant volume or concentration used: yes/no constant concentration
- For solids, paste formed: yes/no: N/A

VEHICLE: N/A
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24h
Doses:
2.0 ml/kg
No. of animals per sex per dose:
3 male & 3 females in TOTM group
2 males & 2 females in control group
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days (or other?): 14d
- Frequency of observations and weighing: weighing on d 1, 7, 14
- Necropsy of survivors performed: yes/no: yes d15
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:
Statistics:
No. N/A single dosage used.

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No confidence limits calculable as no mortality
Mortality:
None
Clinical signs:
other: No signs of toxicity seen during exposure & subsequent observation periods
Gross pathology:
No observed abnormalities at necropsy.

Any other information on results incl. tables

Mean (±SD) Body weights (g) of 3 male & 3 female rabbits exposed to 2.0 ml/kg TOTM and 2 male & 2 female control rabbits

Intervals

Males

Females

 

Control1

TOTM 2.0 ml/kg

Control1

TOTM 2.0 ml/kg

 

 

 

 

 

Pre-exposure

3.2

2.33 ± 0.06

2.8 ± 0.14

2.37 ± 0.06

Day 7

3.4

2. 30 ± 0.10

3.1± 0.07

2.53 ± 0.06

Day 14

3.6

2.46 ± 0.06

3.2 ± 0.14

2.67 ± 0.06

 

 

 

 

 

1Controls were untreated

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test TOTM has an acute dermal LD50 in rabbits of >2.0 ml/kg.
Executive summary:

Acute dermal toxicity (LD50) in the rabbit is in excess of 2 mL/kg