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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08/05/2018-11/05/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Reconstructed Human Epidermis Test Method - adopted in 2013
Method followed: In Vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) with Reconstructed Human
Epidermal Model
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Test material form:
- solid: particulate/powder
- Details on test material:
- They have different version of synthesis based on scale (small, medium, large) There is differences between different scales are related to materials physical properties.
- Specific details on test material used for the study:
- Q0002-1701
In vitro test system
- Test system:
- other: reconstructed Human Epidermal Model.
- Vehicle:
- not specified
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 85.2
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- According to the EU and GHS classification (R38/Category 2 or no label), an irritant is predicted if the mean relative tissue viability of three individual tissues exposed to the test substance is reduced below 50% of the mean viability of the negative controls.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to results obtained from this test implementation, the viability of Reconstructed human epidermal model is > 50%. The product: UPSALITE Q0002-1701 is classified as: NI (Not Irritant)/not required classification.
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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