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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- assessment report
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23/04 - 25/04/2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Cosmeticproduct Test Guidelines for Assessment of Human Skin Compatibility
- Version / remarks:
- COLIPA, Bruxelles 1995.
- Deviations:
- no
- GLP compliance:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- other: human
- Time point:
- 24 h
- Max. score:
- 0
- Reversibility:
- not reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: human
- Time point:
- 24 h
- Max. score:
- 0
- Reversibility:
- not reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- other: human
- Time point:
- 48 h
- Max. score:
- 248
- Reversibility:
- not reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: human
- Time point:
- 48 h
- Max. score:
- 248
- Reversibility:
- not reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Time point:
- 72 h
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test has been carried out according to the Cosmetic Product test Guidelines for Assessment of Human Skin Compatibility, COLIPA, Brussels 1995.
The test has been carried out with the approval of Ethics Committee of the National Institute of Public Health. The selection of subjects and the testing procedure is goerned by the principles laid down in the International Ethical Guidelines for Biomedical Research Involving Human Subjects and has been carried on a voluntary basis. 15 persons aged between 25 and 67 years participated in the test.
On the conditions of the test, no reaction in terms of erythema, oedema or scaliness has been observed in the subjects. - Executive summary:
The test has been carried out according to the Cosmetic Product test Guidelines for Assessment of Human Skin Compatibility, COLIPA, Brussels 1995.
The test has been carried out with the approval of Ethics Committee of the National Institute of Public Health. The selection of subjects and the testing procedure is goerned by the principles laid down in the International Ethical Guidelines for Biomedical Research Involving Human Subjects and has been carried on a voluntary basis. 15 persons aged between 25 and 67 years participated in the test.
On the conditions of the test, no reaction in terms of erythema, oedema or scaliness has been observed in the subjects.
- Reason / purpose for cross-reference:
- assessment report
Reference
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 23/04 - 25/04/2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
- please see attached bellow
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: Cosmetic Product Tes Guidelines for Assessment of Human Skin Compatibility
- Version / remarks:
- COLIPA, Bruxelles 1995
- Qualifier:
- according to guideline
- Guideline:
- other: International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Principles of method if other than guideline:
- For ingredietns, that are toxicological relevant, the Systemic Exposure Dose, SED). SED of the relevant ingredience is the amount, that can get into the bloodstream (and can has the systematic effect). Systemic availability depends on the dermal absorption. It there is no relevant data on absorption of the certain ingredients, it is presume that the ingredience is fully absorbed (100%).
SED(ingr derm) =SEDproduct(A) (mg/kg/d) x Concingr(C)(%) x Dermal absorption(P)(%)
The Margin of Safety (MOS) is required for toxicological relevant ingredience. It can generally be told, that MOS value should be > 100 to presume the safe use. The relevant data must be used for the MOS calculation. therefore the NOAEL is used for the calculation. If there is no relevant data on subacute or subchronic toxicity, it is presumed that NOAEL is 1% of LD50 value. If the substance is not classified as Acute Tox.or health harmful, the LD50 value is > 2000 mg/kg and NOAEL is supposed to be 20 mg/kg/d according to criteria for classification of hazardous chemical substances.
MOS(Ingredience) = NOAEL(Ingredience) / SED (ingredience) - GLP compliance:
- not specified
- Type of study:
- not specified
- Species:
- other: human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Adult (women and men) and children
Average body weight: 60 kg
All skin types - Vehicle:
- not specified
- Concentration:
- SED = 16.7 mg/kg/bw
(SED is calculated according to The SCCS's Notes of Guidance for the Testing of Cosmetic Substances and their Safety Evaluation, 8th Revision, Scientific Committee on Consumer SAfety, SCCS 1501/12). - Details on study design:
- - Amount: 10 g per one application per day
- Application area: the surface of the skin of the palm of the hand
- Retention factor: 0.1
- Exposion: 1h
- Duration time: once per day - Positive control substance(s):
- not specified
- Positive control results:
- N/A
- Key result
- Parameter:
- SI
- Value:
- 248
- Test group / Remarks:
- adutl (women and men)
- Remarks on result:
- other: SED
- Parameter:
- SI
- Value:
- 0
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- On the conditions of the performed test, no reaction in terms of erythema, oedema or scaliness has been observed in the subjects.
- Executive summary:
If the tested item is used by healthy persons under normal or normally foreseeable conditions and according to the instructions for use does not present a risk of irritation, sensitization or other local or systemic, toxicological adverse effects. Composition of the product complies with the requirement of Regulation (EU) no 1223/2009 on cosmetic products.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Cosmetic Product Tes Guidelines for Assessment of Human Skin Compatibility
- Version / remarks:
- COLIPA, Bruxelles 1995
- Qualifier:
- according to guideline
- Guideline:
- other: International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Principles of method if other than guideline:
- For ingredietns, that are toxicological relevant, the Systemic Exposure Dose, SED). SED of the relevant ingredience is the amount, that can get into the bloodstream (and can has the systematic effect). Systemic availability depends on the dermal absorption. It there is no relevant data on absorption of the certain ingredients, it is presume that the ingredience is fully absorbed (100%).
SED(ingr derm) =SEDproduct(A) (mg/kg/d) x Concingr(C)(%) x Dermal absorption(P)(%)
The Margin of Safety (MOS) is required for toxicological relevant ingredience. It can generally be told, that MOS value should be > 100 to presume the safe use. The relevant data must be used for the MOS calculation. therefore the NOAEL is used for the calculation. If there is no relevant data on subacute or subchronic toxicity, it is presumed that NOAEL is 1% of LD50 value. If the substance is not classified as Acute Tox.or health harmful, the LD50 value is > 2000 mg/kg and NOAEL is supposed to be 20 mg/kg/d according to criteria for classification of hazardous chemical substances.
MOS(Ingredience) = NOAEL(Ingredience) / SED (ingredience) - GLP compliance:
- not specified
- Limit test:
- yes
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
Test animals
- Species:
- other: adult (women and men) and children
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Adult (women and men) and children
Average body weight: 60 kg
All skin types
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- not specified
- Details on exposure:
- - Amount: 10 g per one application per day
- Application area: the surface of the skin of the palm of the hand
- Retention factor: 0.1
- Exposure: 1h
- Duration time: once per day - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 1h
- Frequency of treatment:
- one per day
Doses / concentrations
- Dose / conc.:
- 10 mg/kg bw/day
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Endocrine findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- dose level: 10
- Remarks:
- mg/kg bw/day
- Effect level:
- 10 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- dermal irritation
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 414 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- dermal irritation
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 10 mg/kg bw/day
- System:
- ear
- Organ:
- skin
Applicant's summary and conclusion
- Conclusions:
- On the conditions of the performed test, no reaction in terms of erythema, oedema or scaliness has been observed in the subjects.
- Executive summary:
If the tested item is used by healthy persons under normal or normally foreseeable conditions and according to the instructions for use does not present a risk of irritation, sensitization or other local or systemic, toxicological adverse effects. Composition of the product complies with the requirement of Regulation (EU) no 1223/2009 on cosmetic products.
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.