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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:
other: Comparable to guideline with acceptable restrictions (no purity of test substance listed)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986
Reference Type:
secondary source
Title:
1,3,5-TRIOXANE, CAS Number 110-88-3, USEPA HPV Challenge Program Submission
Author:
Trioxane Manufacturers Consortium Members, BASF Performance Copolymers, LLC (Formerly Ultraform Company) and Ticona
Year:
2000
Bibliographic source:
USEPA Submission

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(adopted 1981)
GLP compliance:
yes
Remarks:
(Bio/dynamics Inc)
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): Trioxane (C-235)
- Physical state: solid
- Lot/batch No.: 41115 AT
- Storage condition of test material: in a ventilated, temperature monitored room (15-29 °C)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: males 9 weeks, females 12 weeks
- Mean weight at study initiation:
Group I - males 338 g (310 - 360) females 230 g (220 - 245);
Group II - males 329 g (315 - 342) females 226 g (219 - 239)
- Diet (e.g. ad libitum): Purina Rodent Laboratory Chow
- Water (e.g. ad libitum): automated watering system
- Acclimation period: 28-30 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 100 L
- Source and rate of air: Chamber air was drawn through 1/4" Teflon line and regulated at a flow of 1 L/min for Group I or 0.5 L/min for Group II using a calibrated Dwyer flowmeter and Nupro metering valve. Chamber air was then directed to a glass "Y" tube where it was diluted with room air at a flow of 5 L/min. The resultant 5 to 1 chamber air dilution for Group I, or 10 to 1 chamber air dilution for Group II, was drawn into the Miran using a model Thomas 107CA 183 pump.
- Method of particle size determination: Particle size distribution samples were taken using a TSI Aerodynamic Particle Sizer equiped with a TSI Diluter.
- Temperature, humidity in air chamber: 24-27 °C, 40-48 %


TEST ATMOSPHERE
- Brief description of analytical method used: exposure levels were analysed using a Miran 1A Ambient Air Analyzer and a strip chart recorder.
- Samples taken from breathing zone: yes
- nominal cancentrations were determined by weighing.

TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.6/1.2 µm (exposure 1), 1.1/1 µm (exposure 2)

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Initial dose: 8370 ppm, corresponding to 30.8 mg/l (measured).
Follow up dose: 10643 ppm, corresponding to 39.2 mg/l (measured), which was the maximum attainable vapour 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: All animals were observed individually, immediately prior to exposure, as a group at approximately 15-minute intervals during the first hour of exposure, and hourly thereafter. All animals were observed individually upon removal from the chamber (about one half-hour after exposure was completed) and at hours one and two post-exposure. Body weights were measured at day 1 (immediately prior to exposure), and on days 2, 3, 5, 8, and 15 (just prior to sacrifice).
- Necropsy of survivors performed: yes (including nasal passages, trachea, external surface, orifices, cranial cavity, carcass, brain, spinal chord, thoracic, abdominal and pelvic cavities and their viscera, cervical tissues and organs.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 39.2 mg/L air
Exp. duration:
4 h
Remarks on result:
other: No mortalities observed at the highest tested dose of 39.2 mg/l air.
Mortality:
No mortalities were observed.
Clinical signs:
Increased secretory response, respiratory distress, and general signs of poor condition were reported.
Body weight:
There was a compound-related reduction in body weight for both sexes following exposure (8 - 9%). Animals gained body weight normally during the second week of the observation period.
Gross pathology:
At necropsy, no treatment-related abnormalities were observed, and no target organs could be identified.

Any other information on results incl. tables

Summary of symptoms

Test concentration

8370 ppm ( i.e. 30.8 mg/l air)

Symptom

Onset

Duration

Affected animals/treated animals

Lacrimation

4 h

14 days

Few

Shallow breathing

4 h

Less than 24 h

6/10

Irregular breathing

4 h

2 days

9/10

Reduced activity

45 min.

Less than 24 h

Most

Nasal discharge

4 h

14 days

About the half

10643 ppm (i.e. 39.2 mg/l air)

Lacrimation

15 min.

13 days

Many

Shallow breathing

4 h

Less than 24 h

About the half

Irregular breathing

30 min.

5 days

All

Reduced activity

15 min.

Less than 24 h

All

Nasal discharge

4 h

14 days

Few to most

Summary of body weight data

Body weights (g)

Test concentration

8370 ppm ( i.e. 30.8 mg/l air)

Time point (days)

0

2

3

5

8

15

Males

338

310

319

325

342

364

Females

230

210

218

221

233

239

10643 ppm (i.e. 39.2 mg/l air)

Males

329

293

292

310

330

352

Females

226

210

216

216

224

235

Applicant's summary and conclusion