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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 401, limited documentation

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Reference 3

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 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

Observation period only 7 days instead of 14 days as outlined in OECD TG 401.

Principles of method if other than guideline:

Groups of Sprague-Dawley rats were treated by single gavage administration with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was estimated on the basis of the observed mortalities.

GLP compliance:

no

Test type:

standard acute method

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:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 230 g (mean), female: 182 g (mean)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

emulsion in 0.5% aqueous CMC

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 35%

Doses:

10,000 µL/kg bw equivalent to approx. 8170 mg/kg bw (conversion in mg/kg bw is based on the density of 0.817 g/cm3).

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 4, 7
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 170 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred

Mortality:

No mortality occured.

Clinical signs:

other: No symptoms observed.

Gross pathology:

No abnormalities observed.

Any other information on results incl. tables

Table 1: Mean body weight (g) meisured in animals at three time points:

Dose (mg/kg bw)	Gender	day 0	day 4	day 7
8170	male	230.2	256.4	241
8170	femlae	182	187.2	200.4

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The application of the test substance by gavage up to a dose of 8170 mg/kg bw caused no systemic toxicity in rats.