3-cyclohexylaminopropylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1963

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no statistics provided

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-cyclohexylaminopropylamine

EC Number:

222-001-7

EC Name:

3-cyclohexylaminopropylamine

Cas Number:

3312-60-5

Molecular formula:

C9H20N2

IUPAC Name:

N1-cyclohexylpropane-1,3-diamine

Test material form:

liquid

Details on test material:

3-Cyclohexylaminopropylamine from Performance Chemicals, lot number: 68-219-BC

Test animals

Species:

rat

Strain:

other: Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

weight range of rats was 170 to 260 grams

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Rats were fasted overnight, then given single oral dose of compound by stomach tube. The compound was given undiluted or as a 1:10 dilution in water.
After dosing, each rat was returned to its cage and provided with water and food.

Doses:

100, 215, 464, 1000, 2150 mg/kg

No. of animals per sex per dose:

5 per sex and dose

Control animals:

no

Details on study design:

After dosing, each rat was returned to its cage and provided with water and food. Close observations for signs of toxicity was maintained on each animal the next one or two hours, and at intervals the rest of the working day. Daily checks were made thereafter for seven days at which the general condition of the rats was evaluated and any deaths recorded.
Survivors at seven days were sacrifieced and gross autopsies performed on representatives remaining from the higher doses. Some animals dying during the first day were also autopsied.

Statistics:

not specified

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 200 - <= 237 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 142 - <= 395 mg/kg bw

Based on:

test mat.

Effect levels 3

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

>= 137 - <= 291 mg/kg bw

Based on:

test mat.

Mortality:

Mortality increased in lower dose groups from day 2 to 7 and in higher dose groups (from 464 mg/kg) from 1h to 2 days (see table)

Clinical signs:

other: Excessive salivation, depression, tremors, lacrimation, labored breathing, bloody urine, convulsions

Gross pathology:

At lethal doses extensive gastrointestinal hemorrhaging, urinary bladder hemorrhage.
At non lethal doses: Irritation to gastrointestinal tract, enlarged spleen, discolored kidneys and liver

Any other information on results incl. tables

		Mortality by days
Dose in mg/kg	sex	1 hour	1 day	2 days	3 days	4 days	5 days	6 days	7 days
2150	m	5/5
	f	5/5
1000	m	5/5
	f	5/5
464	m	4/5	4/5	5/5
	f	5/5
215	m						1/5		1/5
	f			2/5					2/5
100	m			1/5					1/5
	f								0/5

Applicant's summary and conclusion

Conclusions:

Based on the test results of the acute oral toxicity study in rats, the LD50 is estimated to be between 200 - 237 mg/kg.

Executive summary:

The acute oral toxicity of the test compound was determined in groups of albino rats consisting of five males and five females. The test material was administrated by gavage once and the animals were observed for seven days. The tested dose concentrations were 100, 215, 464, 100 and 2150 mg/kg. Based on the test results of the acute oral toxicity study in rats, the LD50 is estimated to be between 200 - 237 mg/kg.