2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was undertaken between 17. October and 6. November 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-Azobis[2-(2-imidazolin-2-yl)propane] dihydrochloride

Cas Number:

27776-21-2

IUPAC Name:

2,2'-Azobis[2-(2-imidazolin-2-yl)propane] dihydrochloride

Test material form:

solid: particulate/powder

Remarks:

particle size not specified

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

All rats were acclimated to the experimental environment for a minimum of 7 days prior to the start of the main study. The rats were randomly allocated to cages within the treatment groups. They were house in groups by sex in metal cages with wire mesh floors. A standard laboratory rodent diet and water were provided ad libitum.
Temperature: 20 - 23 °C
Relative humidtiy: 62%
Air exchange: 15/h
Aritificial light: 12h in each 24 hour period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

The test substance was administered to each rat using a syringe and plastic catheter

Doses:

1.6 g/kg
2.5 g/kg
3.2 g/kg
4.0 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Preliminary study:

The results of the preliminary studies indicated that the LD 50 of VA-044 was in the region of 2500 mg/kg BW

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

2 800 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

3 200 mg/kg bw

Based on:

test mat.

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 000 mg/kg bw

Based on:

test mat.

Mortality:

Death occurred amongst rats treated at 2.5 g/kg BW and above generally within one and three hours of dosing. One animal treated at 4.0 g/kg was found dead an Day 2.

Clinical signs:

other: Pilo - erection was observed shortly after dosing in all rats. Abnormal body carriage (hunched posture) also observed in all rats treated at 1.6, 2.5 and 3.2 g/kg and in thre rats treated at 4.0 g/kg bw. These signs were accompaniedby: abnormal gait (wa

Gross pathology:

Renal pallor was observed at autopsy of the rat found dead on Day 2.
Autopsy findings of all other rats that died were normal

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute median lethal oral dose (LD50) and their 95 % confidence limits to rats of VA-044 were estimated to be:

Males and females combined: 3000 mg/kg bw
Males only : 3200 mg/kg bw
Females only : 2800 mg/kg bw