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:
comparable to guideline study with acceptable restrictions
Remarks:
study protocol is in principle similar to OECD TG 403, 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
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:
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 Risk Test (IRT)
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethyl-N,N-bis(2-ethylhexyl)hexylamine
EC Number:
217-461-0
EC Name:
2-ethyl-N,N-bis(2-ethylhexyl)hexylamine
Cas Number:
1860-26-0
Molecular formula:
C24H51N
IUPAC Name:
tris(2-ethylhexyl)amine
Test material form:
liquid
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 or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 217 g (mean), female: 176 g (mean)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
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: 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:
other: 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

The test substance concentration was estimated to be approx. 0.23 mg/L at 20 °C. Vapour saturation was retrospectively calculated to be approx. 0.074 µg/L at 20 °C due to the low vapour pressure of the substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
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 animals were exposed to a saturated vapour atmosphere.