Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

1 (reliable without restriction)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

used for study number KX920469

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Version / remarks:

used for study number KO930129

Deviations:

not specified

Principles of method if other than guideline:

no data

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate

EC Number:

411-760-1

EC Name:

Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate

Cas Number:

116633-53-5

Molecular formula:

C18 H42 Mn2 N6 O3 . 2 F6 P

IUPAC Name:

dimanganese(4+) bis(1,4,7-trimethyl-1,4,7-triazonane) bis(hexafluoro-λ⁵-phosphanuide) hydrate trioxidandiide

Details on test material:

- Name of test material (as cited in study report): Bis (N, N', N''- trimethyl 1,4,7 - triazacyclononane)-tri-
(.mu.oxo)-dimanganese (IV) di(hexafluorophosphate)monohydrate(Commercial Dragon II)
- Molecular formula (if other than submission substance): C18H42Mn2N6O3.2F6P
- Molecular weight (if other than submission substance): 808
- Substance type: powder
- Physical state: red to violet (brown)
- Analytical purity: >98%
- Impurities (identity and concentrations): see section 1.2
- Composition of test material, percentage of components: see section 1.2

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were fasted before test was conducted.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other:

Details on oral exposure:

no data

Doses:

2000 mg/kg (KX920469)
5000 mg/kg (KO930129)

No. of animals per sex per dose:

5 female and 5 male rats (both studies)

Control animals:

not specified

Details on study design:

no data

Statistics:

no data

Results and discussion

Preliminary study:

no data

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: KX920469

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: KO930129

Mortality:

No deaths

Clinical signs:

other: Pilo-erection was observed in all rats within five minutes of dosing and throughout the remainder of Day 1. There were no other clinical signs, and recovery was complete by Day 2.

Gross pathology:

No macroscopic abnormalities were observed.

Other findings:

no data

Any other information on results incl. tables

SIGNS OF TOXICITY: Pilo-erection was observed in all rats within five minutes of dosing and throughout the remainder of Day 1. There were no other clinical signs, and recovery was complete by Day 2.

EFFECTS IN ORGANS: No macroscopic abnormalities were observed.

	Dose	Number of animals	Number of death
Female	2000	5	0
Male	2000	5	0

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

 Acute Oral toxicity (LD50 rat) > 2000 mg/kg
 

Executive summary:

Results of the two conducted studies showed acute oral toxicity (LD50, rat) values of >5000 mg/kg and >2000 mg/kg. Taking the precautionary principle into account, the lowest of these equally reliable values (>2000 mg/kg) was considered to be the acute oral toxicity level.