Reaction mass of 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-6'-hydroxy-4'-methyl-2'-oxo-, inner salt and 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-1',6'-dihydro-2'-hydroxy-4'-methyl-6'-oxo-, chloride (1:1)

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: The test item is the substance in water at 30g/l

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-6'-hydroxy-4'-methyl-2'-oxo-, inner salt and 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-1',6'-dihydro-2'-hydroxy-4'-methyl-6'-oxo-, chloride (1:1)

Molecular formula:

not applicable (reaction mass)

IUPAC Name:

Reaction mass of 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-6'-hydroxy-4'-methyl-2'-oxo-, inner salt and 1,3'-Bipyridinium, 1'-[3-(dimethylamino)propyl]-1',6'-dihydro-2'-hydroxy-4'-methyl-6'-oxo-, chloride (1:1)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test system: Rat, Hanibm: WIST (SPF)
Rationale Recognized by the international guidelines as the recommended test system (e.g. DECO, EEC).
Source BRL, Biological Research Laboratories Ltd. Wolferstrasse 4 CH-4414 Fullinsdorf
Number of animals per group: 3 males + 3 females
Total number of animals: 3 males + 3 females
Age at start of treatment: males : 8 weeks / females: 10 weeks
Body weight at start of treatment: males : 174 - 196 g / females: 174 - 188 g
Identification: By unique cage number and corresponding color-coded spots.
Randomization : Randomly selected at time of delivery in groups of three.
Acclimatization : One week under laboratory conditions after veterinary examination.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

bi-distilled water

Details on oral exposure:

The animals received the test article on a mg/kg body weight base by oral gavage after being fasted for 12 to 18 hours (access to water was not interrupted).
Food was again presented approximately 3 to 4 hours after dosing.
Application Volume/kg body weight: 10 ml at 2000 mg/kg

Doses:

The test article was placed into a glass beaker on a tared Mettler PM 480
balance and the vehicle, (bi-distilled water) was added. A weight by volume
dilution was prepared using a homogenizer (Ultra-Turrax, Janke and Kunkel,
D-7813 Staufen).
Homogeneity of the test article in the vehicle was maintained during treatment
using a magnetic stirrer (Janke and Kunkel, D-7813 Staufen).
The preparation was made immediately prior to dosing.

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no death

Clinical signs:

other: no clinical signs noted

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

the test item has an acute oral LD50 > 2000 mg/kg bw

Executive summary:

The following death rate was observed:

0 % at 2000 mg/kg body weight

Based on these observations, the estimated acute oral toxicity of HMDPY

in rats of both sexes observed for a period of 15 days is: greater than 2000 mg/kg