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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Administrative data

Description of key information

No adverse effects reported

Key value for chemical safety assessment

Toxic effect type:
concentration-driven

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
90 days
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
US National Toxicity Programme study
Justification for type of information:
Published data on key component of the substance
The substance dissociates in water under environmental conditions and an assessment of toxicity can be performed by considering the key dissociated ions present in water.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Principles of method if other than guideline:
Meeting international guidelines as required 1993
GLP compliance:
yes
Limit test:
no
Specific details on test material used for the study:
Technical grade, ca 97%
Species:
rat
Strain:
Fischer 344
Sex:
male/female
Route of administration:
oral: feed
Details on oral exposure:
Feeding at 0, 1600, 3130, 6250, 12500 or 25000 ppm in diet
(equivalent range 110 to 1700 mg/kg males / 115 to 2000 mg/kg in females
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Metal content as Mn
Duration of treatment / exposure:
90 days, daily feeding
Frequency of treatment:
Daily - feeding
No. of animals per sex per dose:
10 male and 10 female
Control animals:
yes, plain diet
Positive control:
No
Observations and examinations performed and frequency:
Clinical findings recorded weekly,
Feed consumption recorded weekly by cage.
Rats weighed at the beginning and weekly thereafter.
At the end of the exposure period, blood was collected for analysis
Sacrifice and pathology:
Full necropsy on all animals.
Organs were weighed.
Complete histopathological examination performed on control and high-dose animals.
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
Males in a mid-treatment group had lower body weight gain than control animals or those in other groups
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not examined
Haematological findings:
effects observed, non-treatment-related
Description (incidence and severity):
Nutrophil counts were significantly higher in all male groups.
Lymphocyte counts were significantly lower in the three highest dose groups.
In females: leukocyte counts were significantly lower in the three highest dose groups.
A significant increase in the haematocrit and erythrocyte counts occurred in males exposed to the three highest dose levels.
Clinical biochemistry findings:
no effects observed
Endocrine findings:
not specified
Urinalysis findings:
not examined
Behaviour (functional findings):
no effects observed
Description (incidence and severity):
Fron clinical and cage-observation
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
effects observed, non-treatment-related
Description (incidence and severity):
Some mid-treatment groups had lower liver weights than control animals or those in other groups
Gross pathological findings:
no effects observed
Description (incidence and severity):
Minor incidental changes not considered significant and apparently not treatment related
Neuropathological findings:
not examined
Description (incidence and severity):
Minor incidental changes not considered significant and apparently not treatment related
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Histopathological findings: neoplastic:
no effects observed
Details on results:
No significant toxicity observed
No clear treatment -related findings
Dose descriptor:
NOAEL
Effect level:
ca. 2 000 OB/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Remarks on result:
not determinable due to absence of adverse toxic effects
Dose descriptor:
NOAEL
Effect level:
ca. 1 700 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Remarks on result:
not determinable due to absence of adverse toxic effects
Dose descriptor:
NOAEL
Effect level:
ca. 570 OB/kg bw/day (nominal)
Based on:
element
Remarks:
Mn
Sex:
male
Remarks on result:
not determinable due to absence of adverse toxic effects
Critical effects observed:
no
Conclusions:
No significant adverse effects observed. Minor blood chemistry effects considered adaptive changes to balance in physiological essential elements.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification