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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions (partly limited documentation; post exposure observation period 7 days; purity unknown)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
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:
Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981)
GLP compliance:
no
Test type:
other: IHT

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Morpholin-Rueckstand (morpholin remainder)
- Substance type: remainder mixture
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gassner (Breeder)
- Mean body weight: 196 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Rats exposed for 8 h to a vapour saturated atmosphere.
Vapour was generated by bubbling 200 l/h dry air (no CO2) through the liquid substance column (volume ca. 50 ml) of about 5 cm above a fritted glass disc in a glass cylinder. The glass cylinder was heated in a water bath. Temperature in the exposure chamber was 20°C. There was no nominal substance loss detected by weighing.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
There was no nominal substance loss detected by weighing. Therefore, no nominal concentration of the test atmosphere can be calculated.
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was done on d0 and d7. Observation was several times at the day of exposure and presumably daily exception of weekends and holidays afterwards.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: IHT (inhalation hazard test)
Exp. duration:
8 h
Remarks on result:
other: No mortality observed after exposure to a saturated atmosphere
Mortality:
0/12
Clinical signs:
other: slight irritation of the mucosa were observed only on the day of application
Body weight:
d0: 196 g; d7: 215 g
Gross pathology:
2* chronical bronchitis & bronchiektasia

Applicant's summary and conclusion