2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Feb 1989 to 13 Apr 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol

EC Number:

202-414-9

EC Name:

2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol

Cas Number:

95-38-5

Molecular formula:

C18H34N2O - C24H46N2O

IUPAC Name:

2-(2-heptadec-8-en-1-yl-4,5-dihydro-1H-imidazol-1-yl)ethanol

Constituent 2

Reference substance name:

(Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol

EC Number:

244-501-4

EC Name:

(Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol

Cas Number:

21652-27-7

Molecular formula:

C22H42N2O

IUPAC Name:

2-(2-heptadec-8-en-1-yl-4,5-dihydro-1H-imidazol-1-yl)ethanol

Specific details on test material used for the study:

- Substance type: organic
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Physical state: Liquid
- Lot/batch No.: 05774HP8

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 174 to 215 g
- Fasting period before study: Prior to treatment fasted overnight.
- Housing: The rats, segregated by sex, were group-housed (5 animals per cage) in Macrolon cages type 4, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin).
- Diet: Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %.
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

Doses:

200 mg/kg (females), 500 mg/kg (males and females), and 2000 mg/kg (males)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily; weighing immediately before administration and on days 7, 14, and at death
- Necropsy of survivors performed: yes; Spontaneously dying animals were submitted to a gross necropsy as soon as possible,- survivors at the
end of the observation period.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Statistics:

The LD50 values were computed by the logit model (J. Berkson, 1944)

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 1 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 1 085 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 265 mg/kg bw

Based on:

test mat.

Mortality:

Males:
500 mg/kg: 2/5
2000 mg/kg: 3/5

Females:
200 mg/kg: 0/5
500 mg/kg: 1/5

Clinical signs:

other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Respiratory sounds were noted in animals dosed with 200 and 500 mg/kg. Slightly to moderately reduced locomotor activity was observed in the animals of the 500 and

Gross pathology:

At autopsy, a hemorrhagic thymus was found in one female of the 500 mg/kg dose group. A dilated stomach and a small intestine was found in two males of the same dose group and in three given 2000 mg/kg. The latter three showed also a dilated caecum.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 values were determined for the test article:

LD50 in male rats: 1000 mg/kg body weight

LD50 in female rats: 1085 mg/kg body weight

LD50 in rats of both sexes: 1265 mg/kg body -weight (lower 95% confidence limit 505 mg/kg)

Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Respiratory sounds were noted in animals dosed with 200 and 500 mg/kg. Slightly to moderately reduced locomotor activity was observed in the animals of the 500 and 2000 mg/kg dose group. A distended abdomen was recorded in single animals of all dose groups. Diarrhea showed one male given 500 and 2000 mg/kg, respectively. The surviving animals of the 500 and 2000 mg/kg bw dose group recovered within 6 to 10 days. At autopsy, a hemorrhagic thymus was found in one female of the 500 mg/kg dose group. A dilated stomach and a small intestine was found in two males of the same dose group and in three given 2000 mg/kg. The latter three showed also a dilated caecum.