Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 235-192-7 | CAS number: 12125-28-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Study period:
- 23/04 - 25/04/2020
- Data waiving:
- study waived due to provisions of other regulation
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
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 governed by the principles laid down in the Internation Ethical Guidelines for BIomedical Research Involving HUman Subjects and has been carrion on a voluntary basis, 15 persons aged between 25 and 67 years participated in the test.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Cosmetic product Test Guidelines for Assessment of Human Skin Compatibility
- Version / remarks:
- COLIPA, Brussels 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: International Ethical Guidelines for Biomedical Research Involving Human Subjects
- GLP compliance:
- not specified
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
Results and discussion
Effect levels
- Key result
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.
