2,2'-azobis[2-methylpropionamidine] dihydrochloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-azobis[2-methylpropionamidine] dihydrochloride

EC Number:

221-070-0

EC Name:

2,2'-azobis[2-methylpropionamidine] dihydrochloride

Cas Number:

2997-92-4

Molecular formula:

C8H18N6.2ClH

IUPAC Name:

2,2'-diazene-1,2-diylbis(2-methylpropanimidamide) dihydrochloride

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Vazo(R) 56 WSP
- Substance type: organic
- Physical state: solid
- Analytical purity: > 97 %
- Lot/batch No.: M0200
- Expiration date of the lot/batch: Not advised, but assumed to be stable for six months from date of receipt
- Storage condition of test material: stored at room temperature in the dark from date of receipt and at 4 °C in the dark from 10 December 1998

Test animals

Species:

rat

Strain:

other: HSD: Sprague-Dawley(CD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan U.K. Ltd., Bicester, Oxon, England
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 94 - 130 g
- Fasting period before study: overnight before and 4 hours after gavage
- Housing: in groups of three, metal cages
- Diet: Special Diet Services RM1(E) SQC expanded pellet ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 or 20 w/v%
- Amount of vehicle (if gavage): 10 ml / kg bw
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): not required
- Purity: not requierd

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not stated

Doses:

200 mg/kg bw, 2000 mg/kg bw

No. of animals per sex per dose:

200 mg/kg bw 3 male, 3 female
2000mg /kg bw 3 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation twice daily, weighing on day 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

no statistics applied

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD100

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

all females dosed at 2000 mg /kg died during the study. All deaths occurred within approximately 70 minutes of dosing. Macroscopic examination revealed congestive changes in the brain and fluid contents in the stomach.

Clinical signs:

other: Piloerection was observed in all rats within four minutes of dosing. This sign persisted and was accompanied in rats later on Day 1 and/or later intervals during the study by; hunched posture, waddling/unsteady gait, lethargy, abnormal respiration, pallid

Gross pathology:

No macroscopic abnormalities were observed for animals that survived treatment and killed at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal oral dose (LD50) to rats of the substance is demonstrated to be between 200 and 2000 mg/kg bodyweight.
By default, this is equivalent to LD50 = 500 mg / kg bw.