Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22. Jun 1965 - 30. Jun 965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
BASF-Test
Principles of method if other than guideline:
BASF-Test. See further details in remarks on material and methods.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monomethylaethanolamin
- Analytical purity: 99-100 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 192 g (mean)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
In the raw data no substance loss but an increase in substance weight was recorded.
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: Inhalation Risk Test
Effect level:
other: Inhalation Risk Test
Exp. duration:
8 h
Mortality:
No mortality occured.
Clinical signs:
Eye and nose discharge.
Body weight:
The animals gained weight.
Gross pathology:
No abnormalities.

Any other information on results incl. tables

The inhalation of a enriched/saturated vapor-air-mixture caused no mortality within 8 h.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Eye and nose discharge were only the abnormalities noted.
Executive summary:

The acute inhalation test demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (room temperature) (BASF AG, 1965, XV/126). 6 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The documentation of clinical signs was performed over a period of 7 days.
No mortalities occurred during the observation period. The animals gained weight. Eye and nose discharge were only the abnormalities noted. Gross pathology revealed no signs of toxicity. LC50was not identified.