Registration Dossier
Registration Dossier
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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- Episkin SA, RHE/S/17, Batch 17-RHE-124
- Details on test system:
- 16 µL of the test item is applied to the epidermal surface of 3 living human skin models during 42 minutes
- Duration of treatment / exposure:
- Treatment during 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42h post-treatment
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 1.7
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: the test item has to be classified in Category 2 or in Category 1.
- Conclusions:
- Based on the experimental study, the substance could be considered as irritating for the skin.
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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