[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of tri- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ -(acetato-O)-di- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese

IUPAC Name:

Reaction mass of tri- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ -(acetato-O)-di- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese

Constituent 2

Reference substance name:

Reaction mass of tri-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ-(acetato-O)-di-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese

EC Number:

700-806-9

Molecular formula:

C42H87Mn2N6O6 and C36H75Mn2N6O6

IUPAC Name:

Reaction mass of tri-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ-(acetato-O)-di-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese

Details on test material:

- Name of test material (as cited in study report): Manganese Octoate/Acetate - MeTACN complex
Description : white solid
Batch number : 16D16603
Purity : >99%
Date received : 12 January 2012
Storage conditions : room temperature in the dark under nitrogen

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 149 - 179 g
- Fasting period before study: overnight fast immediately before dosing.
- Housing: in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water. Treatment of animals was sequential. Sufficient time was allowed between each dose level to confirm the survival of the previously dosed animals.

Doses:

One at 300 mg/kg bw followed by
one at 2000 mg/kg bw followed by
four at 2000 mg/kg bw

No. of animals per sex per dose:

4 x females at 2000 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period at 2000 mg/kg bw.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

No signs of oral toxicity were observed in any of the animals at a dosage of 2000 mg/kg bw.