Triisodecyl benzene-1,2,4-tricarboxylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Study period:

October 23 - November 04 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted according to recognised test methods

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

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

Test material form:

other: 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:

No signs of toxicity seen during exposure & subsequent observation periods

Body weight:

No effects of exposure on body weight. All animals gained weight on days 7 & 14.

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
	Control^1	TOTM 2.0 ml/kg	Control^1	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

¹_{Controls were untreated}

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, the read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, has an acute dermal LD50 in rabbits of >2.0 ml/kg.

Executive summary:

Under the conditions of this test, the read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, has an acute dermal LD50 in rabbits of >2.0 ml/kg bw