Registration Dossier
Registration Dossier
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EC number: 607-097-4 | CAS number: 225234-14-0
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Remarks:
- In vivo photo toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 5 to September 9, 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Supporting information for applying reduced information requirements.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
- Type of study / information:
- In vivo photoxicity tests
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: proDERM Standard Protocol-V04 (71-UV-Tox)
- Deviations:
- not applicable
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Fats and Glyceridic oils, shea butter, unsaponifiable fraction
- EC Number:
- 607-097-4
- Cas Number:
- 225234-14-0
- Molecular formula:
- UVCB substance
- IUPAC Name:
- Fats and Glyceridic oils, shea butter, unsaponifiable fraction
Constituent 1
- Specific details on test material used for the study:
- Lipex Shea Tris (product name for the sponsor has been used in the study)
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- The skin reactions to test product LIPEX SHEA TRIS (F) remained below the range of the negative control Aqua demin. (A), both on irradiated and un-irradiated site. It can be concluded that the test product LIPEX SHEA TRIS does not provoke any photo-toxic reaction under the test conditions applied in this study.
- Executive summary:
The aim of the study was to evaluate levels of photo-toxicity caused by exposure of the test materials to the skin of human subjects for a period of 24 hours, and consecutive with UV-A radiation. The investigation did not deal with the risk of developing contact allergy - or possible beneficial effects of the product on the skin.
The skin reactions to test product LIPEX SHEA TRIS (F) remained below the range of the negative control Aqua demin. (A), both on irradiated and un-irradiated site. It can be concluded that the test product LIPEX SHEA TRIS does not provoke any photo-toxic reaction under the test conditions applied in this study.
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.
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