Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Mar 1969 - 19 Mar 1969
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:
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:
INhalation-Risk-Test: BASF-test, see details in remarks on material and methods
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- 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: 157 g (mean)

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
In the row data no substance loss but an increase in substance weight was recorded.
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: several times on the day of exposure and daily thereafter
- Frequency of weighing: day 0 and day 7
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 8.7 mg/m³ air (nominal)
Exp. duration:
8 h
Remarks on result:
other: no mortality occured within 8h; calculation based on the saturated vapor concentration
Mortality:
No mortality occured.
Clinical signs:
other: No symptoms observed.
Body weight:
The animals gained weight.
Gross pathology:
2x bronchitis

Any other information on results incl. tables

The inhalation of a highly saturated vapour-air mixture for 8 h caused no mortality.

Calculation of the saturated vapor concenration is basd on the vapor pressure at 25°C = 0.002 hPa and the molecular weight = 105.14 g/mol which equals a sat. vapor conc. = 0.0087 mg/L = 8.7 mg/m³.

Applicant's summary and conclusion