Registration Dossier

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: see 'Remark'
Remarks:
Comparable to OECD guideline study. Acceptable, well documented report which meets basic scientific principles. Study was conducted before establishment of the OECD Test Guideline, but study protocol is in principle similar to OECD TG 403, with acceptable restrictions (limited documentation, no analytical monitoring of test atmosphere concentration).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
No analytical verification of test atmosphere concentration.
Principles of method if other than guideline:
BASF-test.
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). 6 rats per sex were exposed to the vapours or aerosol, generated by bubbling 200 L air/h through a substance column of about 5 cm above a fritted glassdisc in a glass cylinder for 8 h. The documentation of clinical signs was performed over a period of 8 days.
GLP compliance:
no
Test type:
other: Inhalation Hazard Test (IHT)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tri-2-Aethylhexylamin
- Physical state: liquid
- Analytical purity: approx. 98%

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 217 g (mean), female: 176 g (mean)

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
BASF-Test: 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). 6 rats per sex were exposed 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 8 h.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
0.23 mg/L (nominal concentration based on the substance loss)
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Frequency of weighing: day 0 and 8
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
0.23 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: IHT: No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound.
Mortality:
No mortality occured.
Clinical signs:
Slight irritation of mucous membranes.
Body weight:
The animals gained weight: males from 217 g to 244 g on day 8 (mean), and females from 176 g to 192 g (mean).
Gross pathology:
No abnormalities observed.

Any other information on results incl. tables

No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that has been saturated at 20 degrees centigrade with the volatile components of the compound.

The test substance concentration was estimated to be approx. 0.23 mg/L at 20 °C. Vapour saturation was calculated to be approx. 0.00012 mg/L at 20 °C due to the low vapour pressure of the substance. Concentrations above the vapour saturation treshold should carefully be considered to be aerosols. Thus, the animals were exposed to a saturated vapour atmosphere, possibly in the presence of some aerosol particles.

Applicant's summary and conclusion