Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06. Nov 1967 - 13. Nov 1967
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:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
Method: BASF-Test: Test was performed in principle as described in OECD Guideline 403.
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 1, 3 and 8 h. The documentation of clinical signs was performed over a period of 7 days.
GLP compliance:
not specified

Test material

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

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 171 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
Remarks on duration:
1, 3 or 8 h
Concentrations:
1 h exposure: 21.39 mg/l
3 h exposure: 21.39 mg/l
8 h exposure: 12.30 mg/l
Nominal concentrations. No verification of concentration by analysis.
No. of animals per sex per dose:
1 h exposure: 6
3 h exposure: 3
8 h exposure: 3
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
Key result
Sex:
male/female
Dose descriptor:
other: Inhalation Risk Test
Remarks:
Saturated vapour at room temperature
Effect level:
> 21.39 mg/L air (nominal)
Exp. duration:
1 h
Remarks on result:
other: No mortalities in 3 males and 3 females exposed to saturated vapour at room temperature
Mortality:
8 h exposure: 4 animals died within 7 h, 1 animal after 24 h and 1 animal after 6 days.
3 h exposure: 3 animals died within 24 h.
1 h exposure: no mortalities.
Clinical signs:
8 h exposure: Initially escape attempts, irritation of mucous membranes, dyspnoea. After the exposure staggering and tremor, swelling of the paws.
3 h exposure: Initially escape attempts, irritation of mucous membranes, dyspnoea. 5 h post exposure crusted eyes and symptoms of corrosion. 1 animal lost the eyesight on one eye.
1 h exposure: Irritation of the mucous membrane, symptoms of corrosion.
Body weight:
The surviving animals gained weight.
Gross pathology:
Animals that died:
Serous crusts at noses and eyes. Hyperemia of the lungs.

Any other information on results incl. tables

Mortality:

   24 h  7 days      
 1 h exposure  0/12  0/12      
 3 h exposure  3/6  3/6      
 8 h exposure  4/6  6/6      

Weight (g):

   day 0  day 7      
 1 h exposure  175 193       
 3 h exposure  163 201      
 8 h exposure  170      

The inhalation of a highly enriched/saturated vapor-air-mixture caused mortality within 3 h.

There is indication that the test substance causes local irritation to exposed tissue including respiratory tract.

Applicant's summary and conclusion