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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
Deviations:
not specified
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
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:
no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
see details study design
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
13 weeks, 7 days/week
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
1 mg/kg of body weight
Basis:
actual ingested
Remarks:
Doses / Concentrations:
15 mg/kg of body weight
Basis:
actual ingested
Remarks:
Doses / Concentrations:
40 mg/kg of body weight
Basis:
actual ingested
Remarks:
Doses / Concentrations:
200 mg/kg of body weight
Basis:
actual ingested
Remarks:
Doses / Concentrations:
1000 mg/kg of body weight
Basis:
actual ingested
No. of animals per sex per dose:
varies.
doses 1, 15, 40 and 200 mg/kg body weight have 10 animals of each sex per dose
doses 0 and 1000 mg/kg body weight have 20 animals of each sex per dose
Control animals:
yes, concurrent vehicle
Details on study design:
Five groups of 20 male and 20 female rats were dosed by oral gavage with Commercial Dragon II (0.01, 0.1, 1, 5 and 500 mg/kg/d) for 13 weeks. A control group of 20 male and 20 female rats were dosed with the vehicle (water). In addition two further groups of 10 male and 10 female rats from both the control and the high dose groups were continued for a recovery period of 8 weeks after the 13 weeks treatment period. Also satellite groups of 10 male and 10 female rats from the control and high dose groups were killed at the end of the 13 weeks treatment period and a range of tissues was taken for analysis of manganese.
Positive control:
no data

Examinations

Observations and examinations performed and frequency:
Faecal analysis, urinalysis, heamatology and clinical chemistry examinations were performed. Histological changes were examined as well as manganese levels in a range of tissues.
Sacrifice and pathology:
see details on study design
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
changes in rats from top dose groups
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
changes in rats from top dose groups
Urinalysis findings:
effects observed, treatment-related
Description (incidence and severity):
changes in rats from top dose groups
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
dose level: Dose/concentration showing no effect
Effect level:
> 5 mg/kg bw (total dose)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Following an eight week recovery period most of these changes regressed or reverted to normal levels. All the males and five out of 10 of the females treated with 500 mg/kg/day showed an increase in the number of thyroid follicles.

Applicant's summary and conclusion

Conclusions:
The no observed adversed effect level (NOAEL) was greater than 5 mg/kg/d of Commercial Dragon II