Registration Dossier

Diss Factsheets

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

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.