Cyclopentylamine

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:

other: no GLP study No OECD and EU guidelines were followed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Method: a) Range finder: Initially, groups of two rats were given a single oral dose of the undiluted test material by gavage using an all metal stomach tube.
b) Animals were each given a single oral dose of the test material at the specified level. animals were observed at 1/4, 1 and 4 hours after treatment and then once daily for fourteen days and the mortalities recorded. Evidence of overt toxicity was also noted.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclopentylamine

EC Number:

213-697-3

EC Name:

Cyclopentylamine

Cas Number:

1003-03-8

Molecular formula:

C5H11N

IUPAC Name:

cyclopentanamine

Constituent 2

Reference substance name:

cyclopenylamine

IUPAC Name:

cyclopenylamine

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A . Tuck and Sons Limited, Battlesbridge, Essex
- Weight at study initiation: 150 - 300 g
- Fasting period before study: yes, overnight
- Housing: Animals were housed by sex in suspended metal cages with mesh floors. A maximum number of five rats were housed in each cage.
- Diet: ad libitum, Rat Diet, supplied by Nottingham University, School of Agriculture, Sutton Bonington, Nr . Louqhborough, Leics .
- Water: water (mains tap), ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3°C
- Air changes (per hr): a minimum of 20 air changes per hour
- Photoperiod (hrs dark / hrs light): the lighting cycle was 14 hours on, 10 hours off

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: a) range finder: 0.05, 0.125, 0.25 mL/kg; b) main test: 0.058, 0.05, 0.085, 0.146, 0.25 mL/kg
- Amount of vehicle: 400 mg/mL

Doses:

a) range finder: 20, 50, 100 mg/kg bw
b) main test: 11.69, 20, 34.2, 58.5, 100 mg/kg bw

No. of animals per sex per dose:

a) range finder: 1
b) main test: 5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (main test)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

26.15 mg/kg bw

Based on:

test mat.

95% CL:

20.41 - 33.51

Clinical signs:

No overt signs of toxicity were oberseved in any of the animals dosed at 11.69 mg/kg bw. At the 20.0 mg/kg bw and 34.2 mg/kg bw dose levels symtoms consisted of subdued activity, pilar erection and anorexia. Survivors at both dose levels showed a marked reduction in bodyweight gain throughout the fourteen day observation period, and two rats at 34.2 mg/kg bw showed pilar erection to days 12 and 14 respectively.
Symptoms at the 58.5 mg/kg bw level consisted of subdued an activity, pilar erection and collapse prior to death. Similar effects were observed in the 100 mg/kg bw group with animals also showing body tremors 4 hours after dosing.

Gross pathology:

Survivors at 20.0 mg/kg bw and 34.2 mg/kg bw showed evidence of anorexia, that is significantly reduced bodyweight gain. Gross necropsy of survivors (one male and one female from each group)revaled no abnormal macroscopic lesions.