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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: Comparable to guideline study with acceptable restriction (pre-GLP study).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
BASF-Test: Test was performed in principle as described in OECD Guideline 403.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methyldiaethanolamin
- Analytical purity: 98 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 183 g (mean)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (room temperature). 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glassdisc in a glass cylinder for 8 h.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
saturated vapor
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: an atmosphere saturated with vapours of the volatile components of MDEA at room temperature caused no mortality
Exp. duration:
8 h
Mortality:
No mortality occured
Clinical signs:
No symptoms observed.
Body weight:
The animals gained normal weight.
Gross pathology:
No abnormalities observed.

Any other information on results incl. tables

In the study report and the raw data no substance loss but an increase in substance weight was recorded. This is an indication that the test substance is hygroscopic and only a marginal fraction of the test substance might be volatile. From a toxicologists point of view it is doubtful if the animals were exposed to the test substance by inhalation and which concentration the generated vapour was of.

Applicant's summary and conclusion