5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

January 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was not conducted under GLP as well as no guideline was cited. However, the study follows OECD TG 206 in main points with the exception of the exposure time of 2 hours, grouping of 5 rats in one chamber, no analysis of concentration of test item in air and no determination of particle size distribution.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

OECD TG 403 (adopted May 1981, updated September 2009) not available at the conduct of the study, deviations to OECD TG 403: exposure of rats 2 hours, 5 animals in a chamber, no analysis of concentration of test item, no particle size distribution

Principles of method if other than guideline:

2 hours of exposure, groups of 5 males tested, treated air not analysed

GLP compliance:

no

Remarks:

GLP required 1981 in EU

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Troenan

IUPAC Name:

Troenan

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Troenan

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Age at study initiation: adult, age not reported
- Weight at study initiation: 185 g
- Fasting period before study: not repoeted
- Housing: not reported
- Diet: Altromin diet No. 1324
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22 °C
- Humidity (%): approx. 50 %
- Air changes (per hr): not reported
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: during January 1981

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

other: whole body of groups of 5 test organisms

Vehicle:

other: ethanol

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the test substance was dissolved in ethanol and applied within an exsiccator using a nebulizer
- Exposure chamber volume:not reported
- Method of holding animals in test chamber: not reported
- Source and rate of air: ambient air
- Method of conditioning air: not reported
- System of generating particulates/aerosols: nebulizer, not further specified
- Method of particle size determination: not conducted since obligatory guideline did not exist during the erformance of the study
- Treatment of exhaust air: measurment of output using a gas meter
- Temperature, humidity, pressure in air chamber: not reported

TEST ATMOSPHERE
- Brief description of analytical method used: no analytics conducted
- Samples taken from breathing zone: no

VEHICLE
- Composition of vehicle: 40 % ethanol
- Concentration of test material in vehicle: 1 % (w/v) solution of Troenan in solvent
- Justification of choice of vehicle: test organisms are considered to be resistent against alcohol
- Lot/batch no.: not reported
- Purity: not reported

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not conducted since obligatory guideline did not exist during the erformance of the study
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not applicable

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

2 h

Concentrations:

750 mg Troenan/m3 (calculated from 30 g Troenan as 1 % ethanol solution in 400 L air over 2 hours)

No. of animals per sex per dose:

5 males per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continous observation during inhalation, survival and symproms of toxicity at day 14, no weighing reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology (2 x larynx,2 x lung lobe and diaphragm lobe)

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

> 750 mg/m³ air (nominal)

Based on:

test mat.

Exp. duration:

2 h

Mortality:

no mortality at 750 mg Troenan/m3

Clinical signs:

other: Macroscopy: suspicion for pneumony, chronic pleuritis Microscopy: small to medium level subacute to chrinic laryngitis and tracheitis in larynges and trachea areas exanined in lungs medium to large level focal interstitial chronic pneumony, in rare cases

Body weight:

not reported

Gross pathology:

see at clinical signs

Other findings:

for histopathology see at clinical signs

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

In a valid and reliable acute inhalation study, the test organsims were exposed to Troenan for two hours in a limit test. The LD50 was determined to be 750 mg Troenan/m3. Due to the histopathological effects, Troenen is assessed as slightly toxic regarding acute inhalation toxicity.

Executive summary:

Testing the acute inhalation toxicity of Troenan using rats did not result in any deaths after a 2 hour exposition to an aerial concentration of 750 mg Troenan/m3 (calculated from the usage of 30 mL 1 % Troenan solution in 40 % ethaol and a through-flow of a total of 400 L air).

Under the conditions used, the LC50 -value is 750 mg/m3. Substance-specific symptoms were not observed. The experimental animals, sacrificed after the 14 day observation period, did not reveal any macroscopic or histologic changes of the respiratory passages which were substance-specific.