Registration Dossier
Registration Dossier
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EC number: 235-192-7 | CAS number: 12125-28-9
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- 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
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
In vivo
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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.
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