1',2'-dihydro-4'-methyl-6'-oxido-2'-oxo-1,3'-bipyridinium

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:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

17 December 2001

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1',2'-dihydro-4'-methyl-6'-oxido-2'-oxo-1,3'-bipyridinium

EC Number:

271-295-3

EC Name:

1',2'-dihydro-4'-methyl-6'-oxido-2'-oxo-1,3'-bipyridinium

Cas Number:

68532-86-5

Molecular formula:

C11H10N2O2

IUPAC Name:

4-Methyl-6-oxo-3-(1-pyridiniumyl)-1,6-dihydro-2-pyridinolate

Test material form:

liquid

Details on test material:

Form: pale yellow liquid

Specific details on test material used for the study:

Sponsor's identification : HMPPB
Description : pale yellow liquid
Storage conditions : room temperature in the dark

Test animals

Species:

rat

Strain:

other: HsdRccHan: WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Females: nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks-old
- Weight at study initiation: 150-173 g
- Fasting period before study: overnight before dosing
- Housing: in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): free access with exception of an overnight fast immediately before dosing and for approximatively 3 to 4 hours after dosing (2014 Taklad Global Rodent diet supplied by Harlan Laboratories UL Ltd., Oxon, UK)
- Water (e.g. ad libitum): free access with exception of an overnight fast immediately before dosing and for approximatively 3 to 4 hours after dosing
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: none
- Concentration in vehicle:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: max dose of 2000 mg/kg bw

Doses:

2000 mg/kg bw

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: clinical observatiobs (0.5; 1; 2 and 4h after dosing and subsequently once daily for 14 days); weighing (days 0; 7 and 14)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths

Clinical signs:

other: Hunched posture was noted in 1 animal 4h after dosing

Gross pathology:

No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of test material in the female Wistar rat was estimated to be >2000 mg/kg bw in acute oral toxicity test performed according to OECD TG 420 and GLP.

Executive summary:

The acute oral toxicity of test material in the female Wistar rat was estimated to be >2000 mg/kg bw in acute oral toxicity test performed according to OECD TG 420 and GLP.