1,2,4-Benzenetricarboxylic acid, mixed branched tridecyl and isodecyl esters

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:

1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted according to sound scientific principles. GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1982

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1983

Reference 3

Reference Type:

publication

Title:

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

Author:

ACC Phthalate Esters Panel HPV Testing Group

Year:

2006

Bibliographic source:

IUCLID 4 Data Set, HPV chemical

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

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

IUPAC Name:

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

Constituent 2

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

Constituent 3

Reference substance name:

Nuoplaz 6959

IUPAC Name:

Nuoplaz 6959

Details on test material:

Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate
Source: Nouplaz 6959, Batch No. 39049, Purity: 98.95%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight at study initiation: 210-275 g for both sexes.
No. of animals per sex per dose: 5 per sex per dose group

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Inhalation Chamber: A 0.5m3 stainless steel inhalation chamber was used. (Youg and Bertke, Cincinnati, Ohio). The test compound atmosphere was generated directly into the chamber by means of Jet Nebulizer Mechanism. Chamber concentrations were monitored by a filter paper/gravimetric technique approximately every 30 min during the exposure period.

The HEPA filtered chamber air-flow was maintained between 10 to 20 air changes per hour during the exposure period with the chamber under slightly negative pressure. The temperature in the chamber was maintained at 69-75 degree F with relative humidity of 30-50%

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

4 h

Concentrations:

2600 mg/m3

No. of animals per sex per dose:

5 per sex

Control animals:

no

Details on study design:

Clinical observations performed and frequency: After the exposure, all animals were observed daily for 14 days for clinical signs of toxicity. Body weights were recorded prior to exposure and weekly thereafter. All animals were subjected to necropsy at termination of the study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 600 mg/m³ air (nominal)

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

No deaths were recorded.

Clinical signs:

other: All animals (male and female) had matted, drenched coats for the first 2 days, otherwise no visible signs. v

Body weight:

The test substance did not cause any changes in body weight.

Mean body weight (g), Mean(S.D.) of rats exposed to this chemical

Males
Initial weight 265.1(8.40)
First week 297.8(14.02)
Second week 329.7(15.27)

Females
Initial weight 213.9(2.66)
First week 223.2(3.96)
Second week 238.1(4.82)

Gross pathology:

All males and 3/5 females exhibited reddening patches on lungs.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LC50 was determined to be > 2600 mg/m3 in male and female rats.

Classification as an inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

The LC50 was determined to be > 2600 mg/m3 in male and female rats.

Classification as an inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.