Bis(2-ethylhexyl)amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05. Jun 1967 - 14. Jun 1967

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:

1967

Report date:

1967

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:

(7 day observation period; highest dose tested was 1612 mg, but all animals of this dose group - besides one male animal - died)

Principles of method if other than guideline:

BASF-Test. The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage 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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl)amine

EC Number:

203-372-4

EC Name:

Bis(2-ethylhexyl)amine

Cas Number:

106-20-7

Molecular formula:

C16H35N

IUPAC Name:

bis(2-ethylhexyl)amine

Details on test material:

- Name of test material (as cited in study report): di-(2-aethylhexyl)-amine
- Analytical purity: > 99%
no further data

Test animals

Species:

rat

Strain:

other: US-rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 254 g (mean), female: 206 g (mean).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous Traganth solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2% (161 mg/kg bw), 20% (806, 1008, 1290, 1612 mg/kg bw)

MAXIMUM DOSE VOLUME APPLIED: 6.25 ml (1250 mg/kg bw), 5 ml (1000 mg/kg bw), 8 ml (1600 mg/kg bw), 10 ml (200 / 2000 mg/kg bw)

Doses:

161, 806, 1008, 1290, 1612 mg/kg bw (= 200, 1000, 1250, 1600, 2000 mL/kg bw ; calculation of doses in mg/kg bw by means of density = 0.8062 g/mL)

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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 008 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Systemic toxicity (including mortality) and local irritation observed; see descritpions below for details

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 1 149 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 847 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Females appeared to be more sensitive.

Mortality:

1612 mg/kg bw: 1 male died within 24 h. 3 males and 5 females died within 48 h. 4 males died within 7 days. 1 male animal survived.
1290 mg/kg bw: 1 male and 3 females died within 24 h. 2 males and 4 females died within 48 h. 5 males and 5 females died within 7 days.
1008 mg/kg bw: 2 females died within 24 h. 5 females died within 48 h. All males survived.
806 mg/kg bw: 1 female died within 7 days. All other animals survived.
161 mg/kg bw: No animal died.

Clinical signs:

other: 1612 – 806 mg/kg bw: Irregular / accelerated respiration, heavy ruffled fur, anogenital region smeared with feces (diarrhea), squatting posture, apathy, red eye and nose crusts. The survivors recovered. 161 mg/kg bw: Same but less distinct symptoms as in

Gross pathology:

dead animals (806 - 1612 mg/kg bw): Dilated stomach in 18 cases, atony in 8 cases, and blood smeared snouts.

sacrificed animals: Uneven faded liver, adhesion between liver, stomach, spleen and left kidney; bronchitis, bronchopneumonia with emphysema.

Any other information on results incl. tables

Mortality

Dose (mg/kg bw)	Gender	1 h	24 h	48 h	7 days
1612	male	0/5	1/5	3/5	4/5
	female	0/5	0/5	5/5	5/5
1290	male	0/5	1/5	2/5	5/5
	female	0/5	3/5	4/5	5/5
1008	male	0/5	0/5	0/5	0/5
	female	0/5	2/5	5/5	5/5
806	male	0/5	0/5	0/5	0/5
	female	0/5	0/5	0/5	1/5
161	male	0/5	0/5	0/5	0/5
	female	0/5	0/5	0/5	0/5

The test substance caused systemic toxicity (including mortality) and local irritation in a dose dependent manner.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The study on acute oral toxicity of Di-2-ethylhexylamin in male and female US-rats resulted in a LD50 value for both sexes of 1008 mg/kg bw. The female animals appeared to be more sensitive. A classification according to the CLP Regulation (EC) No. 1272/2008 (EU-GHS: Cat. 4) is required.