2-ethyl-N,N-bis(2-ethylhexyl)hexylamine

Acute Toxicity: inhalation

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

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

Test material information

Constituent 1

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.