Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water

EC Number:

947-436-6

Molecular formula:

not applicable for UVCB

IUPAC Name:

Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: groupwise n=3 in Makrolon cages type IV
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-15
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

> 1.49 - < 2.2 µm

Remark on MMAD/GSD:

MMAD was 1.49 μm (group 1, 500 mg/m3), 1.53 (group 3, 500mg/m3 repeated) and 2.2 μm (group 2, 1000 mg/m3), resp.

Details on inhalation exposure:

The exposure atmosphere for the study was generated by spraying the RP solution into a continuous air flow with air supplied from the animal hause air conditioning system. After spraying parts of the solution immediately evaporate.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

concentrations of 1078 (group 2, 1000 mg/m3 ), 346 mg/m3 (group 1, 500 mg/m3) and 596 mg/m3 (group 3, 500 mg/m3 repeated).

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

>= 2 000 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No effects observed

Clinical signs:

other: Slight effects like soiled coat and red stains, all reversible within recovery period.

Body weight:

Body weight was slightly decreased until day 3 in both sexes of group 1 (500 mg/m3) and 3 (500 mg/m3 repeated) and markedly decreased until day 3 in both sexes of group 2 (1000m.g/3) and returned to normal afterwards.

Gross pathology:

No findings were observed in males and females of group 1 (500 mg/m3) and group 3 (500mg/m3 repeated).
In group 2 (1000 mg/m3) one female showed findings in the lung (spongy consistency, dark red) and slightly enlarged adrenals.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the study findings in rats perfomed according to the OECD Guideline 436, the test item will be classified under Category 4 of the actual Globally Harmonized System of Classification and Labelling of Chemicals. The LC50 cut-off therefore is 2000 mg/m3 (2 mg/L).

Executive summary:

The aim of the study was to determine the acute inhalation toxicity of the reaction product of DMO-THF, water and ethanol following nose-only exposure according to the OECD Guideline 436. Nine male and nine female Wistar (WU) rats, approximately 12 weeks old at the day of exposure, purchased from Charles River Deutschland, Sulzfeld, Germany, were exposed for 4 hours to the test item (reaction product of DMO-THF, water and ethanol) at three concentrations.