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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Peer reviewed publication
Academic study not following normal guidelines, but included sufficient detail to cover female reproductive effects and developmental toxicity

Data source

Reference
Reference Type:
publication
Title:
Effect of dietary manganese level on tissue manganese, iron, copper and zinc concentrations in female rats and their fetuses
Author:
Järvinen R and Ahlström A
Year:
1975
Bibliographic source:
Medical Biology 53: 93-99

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
From the time of weaning, female rat received diets containing different levels of Mn.
The animals were mated and the offspring collected by caesarean section at day 21 of pregnancy. The number of implantation sites, resorptions and foetuses were recorded.
The foetuses were weighed and observations made.
GLP compliance:
no
Remarks:
Pre-dates GLP
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Manganese sulphate
EC Number:
232-089-9
EC Name:
Manganese sulphate
Cas Number:
7785-87-7
Molecular formula:
MnO4S
IUPAC Name:
Manganese sulphate
Test material form:
solid
Specific details on test material used for the study:
Hydrated form. Dose levels considered high enough to negate the presence of water

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: feed
Analytical verification of doses or concentrations:
not specified
Frequency of treatment:
Daily
Duration of test:
From 10 weeks prior to birth
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
4 mg/kg bw/day (nominal)
Dose / conc.:
24 mg/kg bw/day (nominal)
Dose / conc.:
54 mg/kg bw/day (nominal)
Dose / conc.:
504 mg/kg bw/day (nominal)
Dose / conc.:
154 mg/kg bw/day (nominal)
Dose / conc.:
1 004 mg/kg bw/day (nominal)
No. of animals per sex per dose:
17 females in each group
Control animals:
yes, plain diet

Examinations

Maternal examinations:
General condition, weights, embryonic reabsorption

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
no effects observed
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Neuropathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Other effects:
no effects observed

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Description (incidence and severity):
dose related
Total litter losses by resorption:
not examined
Early or late resorptions:
no effects observed
Dead fetuses:
no effects observed
Changes in pregnancy duration:
no effects observed
Changes in number of pregnant:
no effects observed

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Remarks:
Maternal health
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects

Maternal abnormalities

Abnormalities:
no effects observed

Results (fetuses)

Fetal body weight changes:
no effects observed
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
no effects observed
Description (incidence and severity):
No considered significant
Changes in litter size and weights:
no effects observed
Changes in postnatal survival:
not examined
External malformations:
no effects observed
Skeletal malformations:
no effects observed
Visceral malformations:
no effects observed
Description (incidence and severity):
No soft-tissue malformations noted
Other effects:
no effects observed

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Remarks on result:
not determinable due to absence of adverse toxic effects

Fetal abnormalities

Abnormalities:
no effects observed

Overall developmental toxicity

Developmental effects observed:
no

Any other information on results incl. tables

 

Applicant's summary and conclusion

Conclusions:
No adverse effects on developmental toxicity
No adverse effects on female fertility