Triisotridecyl benzene-1,2,4-tricarboxylate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

02 - 24 Dec 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. No particle size determination was performed. No information on housing conditions during observation period.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1982

Reference 2

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

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Federal Insecticide, Fungicide, and Rodenticide Act, Part 163, Title 40; Code of the Federal Regulations 40 CRF 163.81

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

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

Molecular formula:

C33H54O6

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): Tris(2-ethylhexyl)trimellitate
- Analytical purity: 98.95%
- Impurities (identity and concentrations): 0.05% 2-ethylhexanol and 1% miscellaneous esters
- Lot/batch No.: 39049

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Portage, USA
- Weight at study initiation: 210-275 g
- Diet (e.g. ad libitum): Ziegler NIH-07 open block formula (Gardners, Pennsylvania), ad libitum; feed was withdrawn during the exposure period
- Water (e.g. ad libitum): water, ad libitum; water was withdrawn during the exposure period
- Acclimation period: 8 days

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel inhalation chamber was used (Young and Bertke, Cincinnati, USA)
- Exposure chamber volume: 0.5 m³
- Source and rate of air: HEPA filtered air, 10 to 12 changes per hour
- System of generating particulates/aerosols: Jet Nebulizer Mechanism (Rhema Co., Germany)
- Temperature, humidity, pressure in air chamber: 22.3 °C, 40 ± 10%, slightly negative pressure (0.1 to 0.2 in. water using a Magnehelix gauge)

TEST ATMOSPHERE
- Brief description of analytical method used: chamber concentrations were monitored by a filter paper/gravimetric technique approximately every 30 min during the 4-hr exposure period.

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no data
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): no data

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetrically

Duration of exposure:

4 h

Concentrations:

2600 mg/m³ (nominal concentration)
2588.6 ± 320.85 mg/m³ (analytical concentration)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: after exposure, animals were observed daily during the 14-day observation period. Body weights were recorded prior to exposure and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Mean values and standard deviations were calculated for body weights and analytical concentration of the aerosol.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 588.6 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortalities occurred during the study.

Clinical signs:

other: At clinical observation, all animals showed matted, drenched coats for the first 2 days after exposure. Otherwise, no clinical signs of toxicity were noted up to the end of the 14-day observation period.

Body weight:

The animals showed the expected gain in body weight over the study period.

Gross pathology:

In all males and 3/5 females, reddening patches on the lungs were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified