Manganese, [[2,2',2''-[nitrilotris[2,1-ethanediyl(nitrilo-.kappa.N)methylidyne]]tris[phenolato-.kappa.O]](3-)]-, (OC-6-22)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11.10. - 10.12.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December, 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

479-540-8

EC Name:

-

Cas Number:

61007-89-4

Molecular formula:

C27 H27 Mn N4 O3

IUPAC Name:

manganese(3+) 2-[({2-[bis(2-{[(2-oxidophenyl)methylidene]amino}ethyl)amino]ethyl}imino)methyl]benzen-1-olate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: Males: 9 weeks, females: 13 weeks
- Weight at study initiation: Males: 249.9 -251.6 g; females: 170.4 - 178.6 g
- Fasting period before study: approximately 18 hrs (access to water was permitted)
- Housing: In groups of three per sex in Makrolon type-4 cages
- Diet: standard diet, ad libitum
- Water: community tap water, ad libitum
- Acclimation period: 7 days, under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30-70 %
- Air changes (per hr): 10 -15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: from 11.10. - 05.11.2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.

Doses:

2000 mg/kg bw/d

No. of animals per sex per dose:

3 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:
Mortality/Viability: Daily during acclimatization and twice daily during days 1 -15.
Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed during the course of the study.

Gross pathology:

No macroscopic findings were recorded at necropsy.