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Diss Factsheets
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EC number: 235-192-7 | CAS number: 12125-28-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- other: expert opinon based on the similar subtances
- Adequacy of study:
- weight of evidence
- 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:
- The present expert opinion is based on the well-accepted hypothesis that the source and target substances have similar toxicological properties – reproductive toxicity in the present case – due to structural similarity. The analysis prediction is supported by the known properties of a trio of inorganic compounds representing the same ions/groups making up the target compound. Therefore, the source and target compounds can be considered structurally very similar. Moreover, in the acidic (hydrochloric acid in particular) environment of the stomach, the target compound entering via the oral route would be quickly converted into magnesium chloride -compound Source 3. While magnesium carbonate would be a preferred second source compound due to closer similarity, reproductive toxicity studies for this compound are not available, therefore, calcium carbonate has been chosen instead.
Purity and impurities
The source and target compounds can be considered to be of similar purity, as these inorganic compounds can be obtained with similar purity at similar cost/effort. Neither the source nor the target compounds contain impurities relevant to the classification.
Structural similarity
Each of the structural features as ions/fragments existing in the target compound is represented by ions/fragments of the source compounds. The magnesium and hydroxide parts in magnesium hydroxide and the carbonate part in calcium carbonate. The actual form of the target compound after oral administration can be taken as that of source 2 compound.
Physicochemical similarity
Most of the physicochemical properties of the source and target compounds are close to each other. All of the considered substances are ionic solids, soluble in the acidic medium of the stomach.
Toxicology data
The reproductive toxicity of Source 1 and Source 2 have a reliability score of 2, being read-across from Source 3 and a nano-form of the chemically identical compound, respectively. The Source 3 compounds has been assessed in vivo, with a reliability score 1 study (reliable without restrictions), as described on the ECHA listing of the respective chemicals.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- other: expert opinion
- Adequacy of study:
- weight of evidence
- 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:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH AND JUSTIFICATION
The present expert opinion is based on the well-accepted hypothesis that the source and target substances have similar toxicological properties – genetic toxicity in the present case – due to structural similarity. The analysis prediction is supported by the known properties of a pair of inorganic compounds representing the same ions/groups making up the target compound. Therefore, the source and target compounds can be considered structurally very similar. Moreover, in the acidic (hydrochloric acid in particular) environment of the stomach, the target compound entering via the oral route would be quickly converted into magnesium chloride - the Source 2 compound.
While magnesium carbonate would be the direct source compound due to closer similarity, genetic toxicity studies for this compound are not available, or rather the analysis for regulatory purposes has also been read-across from Source 2, according to similar justifications as presented above.
The source and target compounds can be considered to be of similar purity, as these inorganic compounds can be obtained with similar purity at similar cost/effort. Neither the source nor the target compounds contain impurities relevant to the classification
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- Target gene:
- hypoxanthine-guanine phosphoribosyl transferase gene – the HPRT test (Hprt and HPRT in rodent and human cells, respectively), and the xanthine-guanine phosphoribosyl transferase transgene (gpt) (the XPRT test).
- Metabolic activation:
- not applicable
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- not measured/tested
- Conclusions:
- The structural similarities between the source and the target substances and the similarities in
their ionic constituents support the read-across hypothesis and the analysis. Adequate, reliable and available scientific information indicates that the source and target substances and their dissociation products (cations and anions) have similar toxicity profiles.
In rigorous experimental studies, the source compounds have not been classified as genotoxic or mutagenic. Based on these considerations, the experimental assessment of the target compound is expected to yield the same results as that of the source compounds, resulting in “non mutagenic” interpretation. The conclusion is further justified by the fact that magnesium is an essential element to life, the levels of which in a body are actively regulated, while magnesium deficiency causes serious disorders. - Executive summary:
The structural similarities between the source and the target substances and the similarities in their ionic constituents support the read-across hypothesis and the analysis. Adequate, reliable and available scientific information indicates that the source and target substances and their dissociation products (cations and anions) have similar toxicity profiles.
In rigorous experimental studies, the source compounds have not been classified as genotoxic or mutagenic. Based on these considerations, the experimental assessment of the target compound is expected to yield the same results as that of the source compounds, resulting in “non mutagenic” interpretation. The conclusion is further justified by the fact that magnesium is an essential element to life, the levels of which in a body are actively regulated, while magnesium deficiency causes serious disorders.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Magnesium carbonate hydroxide
- EC Number:
- 235-192-7
- EC Name:
- Magnesium carbonate hydroxide
- Cas Number:
- 12125-28-9
- Molecular formula:
- Mg5(CO3)4(OH)2(H2O)4
- IUPAC Name:
- Magnesium carbonate hydroxide
- Test material form:
- solid: particulate/powder
Constituent 1
Administration / exposure
- Route of administration:
- other: oral (feed and gavage)
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Endocrine 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
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Remarks on result:
- not measured/tested
Target system / organ toxicity (P0)
- Critical effects observed:
- no
- System:
- other: not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Endocrine findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- 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
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (P1)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Sexual maturation:
- no effects observed
- Anogenital distance (AGD):
- no effects observed
- Nipple retention in male pups:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- no effects observed
Effect levels (F1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- no
- System:
- other: not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Treatment related:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.