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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

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
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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Portage Michigan USA
- Age at study initiation: No data
- Weight at study initiation: 210-275 g
- Fasting period before study: No data
- Housing: A 0.5 m3 stainless steel inhalation chamber (Young & Bertke Cincinnati Ohio) during exposure period
- Diet (e.g. ad libitum): yes, Zeigler NIH07 open block formula (Gardners Pennsylvania USA)
- Water (e.g. ad libitum): yes, via water bottles
- Acclimation period: 8d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72+/-3 degrees F
- Humidity (%): 40+/- 10%
- Air changes (per hr): 10-20 during exposure period
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: December 2 1981 To: December 24 1981

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A 0.5 m3 stainless steel inhalation chamber (Young & Bertke Cincinnati Ohio)
- Exposure chamber volume: 0.5m3
- Method of holding animals in test chamber: No data
- Source and rate of air: No data
- Method of conditioning air: No data
- System of generating particulates/aerosols: Jet Nebuliser (Rhema Co. West Germany)
- Method of particle size determination: No data
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: 2+/-3 degrees F; 40+/- 10%; 0.1-0.2 in. H20 (using a Magnehelix gauge)
TEST ATMOSPHERE
- Brief description of analytical method used: filter paper/gravimetric technique; samples taken approximately every 30 mins during 4h exposure period
- Samples taken from breathing zone: yes/no: No data

VEHICLE
- Composition of vehicle (if applicable): N/A
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:

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

CLASS METHOD (if applicable): N/A
- Rationale for the selection of the starting concentration: No data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
Estimated concentration: 2,600 mg/m3
Actual concentration: 2, 588.6 mg/m3 by gravimetric measurement
No. of animals per sex per dose:
5 males & 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?): 14d
- Frequency of observations and weighing: mortality & clinical signs daily, body weights: pre-exposure & weekly thereafter
- Necropsy of survivors performed: yes/no: yes on d15
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: clinical signs, body weights & macroscopic observation at necropsy.
Statistics:
N/A limit test; means and SDs calculated

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 600 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: single dose concentration
Mortality:
None
Clinical signs:
All animals had matted, drenched coats for days 1-2 of observation period. There were no signs of toxicity during the exposure, the subsequent observation period or at termination.
Body weight:
With respect to body weights pre exposure, body weight increased on days 7 & 14 of the observation period.
Gross pathology:
At necropsy on d15, 5/5 males & 3/5 females had reddened patches on the lung.
Other findings:
No data

Any other information on results incl. tables

Mean (SD) Body weights (g) of 5 male & 5 female rats exposed to 2600 mg/m3TOTM

Intervals

Males

Females

 

 

 

Pre-exposure

265.1 ± 8.40

213.9 ± 2.66

Day 7

297.8 ± 14.02

223.2 ± 3.96

Day 14

329.7 ± 15.27

238.1 ± 4.82

 

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The authors concluded that under the conditions of this experiment 2,600 mg/m3 Nuoplaz 6959/Tris (2-ethylhexyl)trimellitate had little or no effect on the rat after a 4h exposure.
Executive summary:

The acute 4 hour inhalation toxicity (LC50) in the rat is in excess of 2600 mg/m3