Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 - 13 November 1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: BASF-Test: Test was based on the Inhalation Hazard (Inhalation Risk) test and was performed in principle according to OECD Guideline 403.
The test is aimed to demonstrate 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:
no
Remarks:
pre-GLP
Test type:
other: inhalation hazard test
Limit test:
no

Test material

Constituent 1
Reference substance name:
Methylpiperazine
IUPAC Name:
Methylpiperazine
Details on test material:
- Name of test material (as cited in study report): Monomethylpiperazin
- Analytical purity: 99 %
Specific details on test material used for the study:
- 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 or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 171 g (mean)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
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:
no
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 21.39 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Remarks on result:
other: No mortalities in 6 males and 6 females exposed to saturated vapour at room temperature
Sex:
male/female
Dose descriptor:
LC50
Effect level:
21.39 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
3 h
Remarks on result:
other: 50% mortality; exposed to saturated vapour at room temperature
Sex:
male/female
Dose descriptor:
LC100
Effect level:
12.3 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: 100% mortality; 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:
other: see below
Body weight:
The surviving animals gained weight.
Gross pathology:
Animals that died: serous crusts at noses and eyes, hyperemia of the lungs.
Other findings:
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

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      

Mean 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

Conclusions:
The inhalation of a highly enriched/saturated vapor-air-mixture caused mortality within 3 h. The test substance causes local irritation to exposed tissue including respiratory tract.