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EC number: 237-997-9 | CAS number: 14154-09-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Group size was not appropriate (10 to 11 pregnant rats, 20 pregnant rats were required with a minimum requirement of 16 pregnant rats if mortality occurs). Food consumption not recorded. Necropsy of dams incomplete (uterus and liver were examined), foetal data incomplete (litter size, sex, soft tissue defects missing). Purity of test material not stated.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of the dietary manganese level on tissue manganese, iron, copper and zinc concentrations in female rats and their fetuses
- Author:
- R. Järvinen and A. Ahlström
- Year:
- 1 975
- Bibliographic source:
- Medical Biology 53: 93-99
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female rats were fed with manganese sulphate heptahydrate containing diets and mated after 8 weeks of exposure with males receiving normal rat diet. Pregnant females were sacrificed at day 21 of pregnancy. Maternal livers and uterus were examined as well as fetuses. Additionally, mineral contents (manganese, iron, copper and zinc) in fetuses and in livers of pregnant and non-pregnant females were analysed.
- GLP compliance:
- not specified
- Remarks:
- not specified in publication
- Limit test:
- no
Test material
- Reference substance name:
- manganese(2+);sulfate;heptahydrate
- Cas Number:
- 13492-24-5
- Molecular formula:
- H14MnO11S
- IUPAC Name:
- manganese(2+);sulfate;heptahydrate
- Test material form:
- not specified
- Details on test material:
- not specified
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Orion Yhtymä Oy, Ylä-Mankkaa Farm, Mankkaa, Finland
- Age at study initiation: not specified
- Weight at study initiation:
Group I: 66 ± 1 g
Group II: 66 ± 2 g
Group III: 66 ± 2 g
Group IV: 66 ± 1 g
Group V: 66 ± 1 g
Group VI: 66 ± 1 g
- Fasting period before study: not specified
- Housing:
housed individually in in wire-bottom stainless steel cages
- Diet ad libitum:
females: low-manganese basal diet (16 % protein, 9 % fat, 65 % carbohydrate, 4.1 kcal/g, 4.3 % average moisture)
Males: commercial mouse and rat chow (Orion Yhtymä Oy, Ylä-Mankkaa Farm, Mankkaa, Finland)
- Water ad libitum: tap water
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Experimental diets were prepared by adding to the salt mixture suitable quantities of manganese sulphate heptahydrate. Experimental diets were prepared in 15-kg portions in a Horbart mixer and stored in plastic containers.
DIET PREPARATION
- Rate of preparation of diet (frequency): not specified
- Mixing appropriate amounts with (Type of food): low-manganese basal diet (16 % protein, 9 % fat, 65 % carbohydrate, 4.1 kcal/g, 4.3 % average moisture)
- Storage temperature of food: -10 °C - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused: 10 females from groups I, IV and V and 11 females from group II, III and VI were mated.
- M/F ratio per cage: 1 male and 3 females
- Length of cohabitation: overnight
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 8 to 11 weeks
- Frequency of treatment:
- daily
- Duration of test:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 24 mg/kg diet
- Remarks:
- based on element (mg Mn/kg dry diet)
- Dose / conc.:
- 54 mg/kg diet
- Remarks:
- based on element (mg Mn/kg dry diet)
- Dose / conc.:
- 154 mg/kg diet
- Remarks:
- based on element (mg Mn/kg dry diet)
- Dose / conc.:
- 504 mg/kg diet
- Remarks:
- based on element (mg Mn/kg dry diet)
- Dose / conc.:
- 1 004 mg/kg diet
- Remarks:
- based on element (mg Mn/kg dry diet)
- No. of animals per sex per dose:
- 17 females/group
thereof were 10-11 females mated and 6-7 females served as non-pregnant controls (treated like pregnant females) - Control animals:
- yes, plain diet
- other: non-pregnant females in all dose groups
- Details on study design:
- - Dose selection rationale:
Doses were selected based on optimum manganese level for rat growth that was stated as 40 mg/kg dry diet.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly and additionally on days 0 and 21 of pregnancy
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: uterus, livers - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of fetuses: Yes - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: No data
- Skeletal examinations: 5 fetuses
- Head examinations: No data
OTHER:
- fetuses were weighed individually
- 30 fetuses fom each group were analyzed for the dry matter content
- 8-10 fetuses from each group were analyzed for the ash content
- pooled samples of two fetuses from each litter were used for mineral analyses - Statistics:
- From the analytical data arithmetic means and standard errors (SE) were calculated. The significance of differences between the experimental groups was tested by the Student's t-test.
- Indices:
- No data
- Historical control data:
- No data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- 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 specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- hemoglobin concentration was significantly lower in pregnant females of group VI (1004 mg Mn/kg dry diet) compared to groups II and III (24 and 54 mg Mn/kg dry diet, respectively).
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- The manganese content in liver was increased in pregnant females compared to non-pregnant females in a dose dependant manner. Manganese intake had no effect on manganese concentrations in livers of non-pregnant females.The liver iron content decreased with increasing manganese intake, this effect was more pronounced in non-pregnant females than in pregnant females. The liver copper content was elevated only in pregnant females of the high dose group. Liver zinc content was not affected by manganese intake.
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
- 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
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- not specified
- Details on embryotoxic / teratogenic effects:
- Manganese contents in fetuses only slightly increased and reflected manganese intake of the dams.
Effect levels (fetuses)
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Female rats were fed with manganese sulphate heptahydrate containing diets and mated after 8 weeks of exposure with males receiving normal rat diet. Pregnant females were sacrificed at day 21 of pregnancy. Maternal livers and uterus were examined as well as fetuses. Additionally, mineral contents (manganese, iron, copper and zinc) in fetuses and in livers of pregnant and non-pregnant females were analysed. No adverse effects were observed in all animals. The manganese content in liver was increased in pregnant females compared to non-pregnant females in a dose dependant manner. Manganese intake had no effect on manganese concentrations in livers of non-pregnant females.The liver iron content decreased with increasing manganese intake, this effect was more pronounced in non-pregnant females than in pregnant females. The liver copper content was elevated only in pregnant females of the high dose group. Liver zinc content was not affected by manganese intake. Manganese contents in fetuses only slightly increased and reflected manganese intake of the dams.
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