Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptabel for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
12 May 1981
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 (20°C). 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 8h. The documentation of clinical signs was performed over a period of 7 days. In order to verify the results, the test was repeated once.
GLP compliance:
no
Test type:
other: Inhalation-risk test (IRT)
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(dimethylamino)propan-2-ol
EC Number:
203-556-4
EC Name:
1-(dimethylamino)propan-2-ol
Cas Number:
108-16-7
Molecular formula:
C5H13NO
IUPAC Name:
1-(dimethylamino)propan-2-ol
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimethyl-isopropanolamin
- Physical state: liquid
no further data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
not specified
Remarks on duration:
3, 10 or 30 minutes
Concentrations:
Saturated dimethyl-isopropanolamin atmosphere.
Using the vapour pressure of 11.7 hPa at 20 °C and the molecular weight of 103.2 g/mol, a theoretical saturated vapour concentration of 49.6 mg/L can be calculated.
No. of animals per sex per dose:
3-6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7days
- Frequency of observations and weighing: observations: daily; weighing: at the beginning and end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight (group only, no single animal weights)

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Exp. duration:
3 min
Remarks on result:
other: no deaths were observed when exposed to the test substance for 3 minutes
Sex:
male/female
Exp. duration:
10 min
Remarks on result:
other: 1/12 animals died when exposed to the test substance for 10 minutes
Sex:
male/female
Exp. duration:
30 min
Remarks on result:
other: 6/6 animals died when exposed to the test substance for 30 minutes
Mortality:
0/12 animals died when exposed for 3 min
1/12 animals died when exposed for 10 min
6/6 animals died when exposed for 30 min
Clinical signs:
other: attempts to escape, severe irritation of the mucous membrane, dyspnoea, blood incrusted nose
Body weight:
30 min: group mean: ca. 171 g at the beginning of the study, no body weights taken at the end of the study due to the death of the animals
10 min: group mean: ca. 164 g at the beginning of the study, ca. 208 g at the end of the study
3 min: group mean: ca. 179 g at the beginning of the study, ca. 165 g at the end of the study
Gross pathology:
sacrificed animals: organs without findings
died animals: greyish-brown incrustation in the nasal area

Applicant's summary and conclusion

Categories Display