Registration Dossier

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1982
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 guidelineopen allclose all
Qualifier:
according to
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
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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- Diet (e.g. ad libitum): Ziegler NIH-07 open block formula (Gardners, Pennsylvania), ad libitum; feed was withdrawn during the exposure period
- Water (e.g. ad libitum): water, ad libitum; water was withdrawn during the exposure period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:
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