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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 294-955-2 | CAS number: 91771-62-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cyperus scariosus, Cyperaceae.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Human Repeated Insult Patch (HRIPT)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 13/09/2006-05/12/2006
- 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 LLNA study conducted resulted in non-conclusive outcome.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Marzulli-Mailbach method was used to carry out Human Repeated Insult Patch test to study sensitization potential of a product in human volunteers. The test item was applied in maximized conditions (occlusion or semi-occlusion) during 3 weeks (Induction phase). After two-week rest phase, the products are reapplied on the same sites (Challenge phase). If the product is allergenic, it induces a cutaneous reaction during the challenge phase.
- GLP compliance:
- yes
- Remarks:
- Standards of Good Clinical Practice Guidelines according to guidelines of ICH
- Type of study:
- other: Marzulli-Maibach method
Test material
- Reference substance name:
- Cyperus scariosus, ext.
- EC Number:
- 294-955-2
- EC Name:
- Cyperus scariosus, ext.
- Cas Number:
- 91771-62-9
- IUPAC Name:
- Cyperus scariosus, ext.
- Test material form:
- liquid
Constituent 1
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Day 36
- Hours after challenge:
- 0
- Group:
- test chemical
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Day 37
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Day 38
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Day 39
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Day 40
- Hours after challenge:
- 96
- Group:
- test chemical
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the Human Repeated Insult Patch (HRIPT) study no signs of sensitizing potential of test item, Cyperus scariosus, ext was detected.
- Executive summary:
Marzulli-Mailbach method was used to carry out Human Repeated Insult Patch test to study sensitization potential of test item in 100 human volunteers.The application of 15% of the Cyperus scariosus, ext. item did not cause signs of sensitization.
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.
