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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: Acceptable, well-documented study report which meets basic scientific principles. Only a 2 hour exposure period.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report Date:
1956

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF-Test (IRT = inhalation risk test): The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of the test substance at the temperature chosen for vapor generation (220 °C). In a 400 l chamber two groups of 4 rats per group were exposed to the test substance vapors for 2 hours. Group-wise documentation of clinical signs was performed over the 8-day study period. The clinical signs and findings were reported in summarized form.
GLP compliance:
no
Test type:
other: inhalation risk test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diaethylenglykolmonobutylaether = Butylpolyglykol; Butyldiglykol
- Physical state: clear liquid
- Analytical purity: 98%
- Impurities (identity and concentrations): 2% Triethylene glycol butyl ether

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: evaporator (continuous infusion); static exposure chamber
- Exposure chamber volume: 400 l

TEST ATMOSPHERE
- Brief description of analytical method used: no analytics performed
- Samples taken from breathing zone: no
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
2 h
Concentrations:
3 mg/l (calculated as quotient of the amount of test substance weight loss during the evaporation)
No. of animals per sex per dose:
8 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
other: inhalation risk test
Effect level:
> 29 ppm
Exp. duration:
2 h
Remarks on result:
other: no mortalities; slight eye-irritating potential. Concentration shown is theoretical saturated vapour concentration (2.9Pa)
Mortality:
No mortality was observed up to the saturated vapour concentration.
Clinical signs:
The test substance showed a slight eye-irritating potential.
Body weight:
no findings
Gross pathology:
no findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute inhalation toxicity of Diaethylenglykolmonobutylaether (as an aerosol) is small under the applied experimental conditions. However, a mucous membrane irritating potential was reported.
Executive summary:

In an acute inhalation risk assessment assay that followed the basic principles as described in OECD test guideline 403, rats were exposed to an atmosphere saturated with vapors of the substance 2 -(2 -butoxyethoxy)ethanol for a period of 2 hours. Documentation of clinical signs was performed over the 8-day study period. No signs of mortality or adverse clinical signs apart from evidence for some eye irritation were observed. This could have been due to aerosol exposure as the vapour generation method did not exclude this possibility. On the basis of this result, the substance does not warrant classification for an acute inhalation hazard.