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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 617-849-3 | CAS number: 86404-04-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- other: many
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
- Principles of method if other than guideline:
- Expert judgement based on data contained in this registration dossier
- GLP compliance:
- yes
- Type of study:
- other: many
Test material
- Reference substance name:
- (5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one
- EC Number:
- 617-849-3
- Cas Number:
- 86404-04-8
- Molecular formula:
- C8H12O6
- IUPAC Name:
- (5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Based on expert judgement
Any other information on results incl. tables
See attachment in the endpoint summary.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- EAA is a water soluble, low molecular weight substance with potential to penetrate in the skin. The test substance showed no in vitro skin irritation in the EPIDERM test, and 0.02 mL test item diluted at 2%, given on the external face of the arm (semi‐occluded) was not irritating in a human skin patch test in 11 volunteers. In a repeated insult patch test, pure test item applied in 56 human subjects, of which 24 volunteers with sensitive skin, the formulation did not induce clinically
significant skin irritation nor was there any evidence of induced allergic contact dermatitis in human subjects. The test item was considered “hypoallergenic”
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