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Toxicological information

Acute Toxicity: inhalation

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Reference Type:
publication
Title:
Unnamed
Year:
1983
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:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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 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:
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.