Registration Dossier
Registration Dossier
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EC number: 943-154-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study following in-vitro guideline performed on a similar substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
- Principles of method if other than guideline:
- Dermal Irritection Assay System (refinement of the former Skintex method).It is an in-vitro irritation prediction method that uses non-human substrates as a biomembrane barrier macromolecular matrix system. In particular former Skintex (TM) used a two-compartment physico-chemical model incorporating a keratine/collagen membrane barrier and an ordered macromolecular matrix. When irritating agents are applied to the matrix of the test, they produce effects as they produce nucleation of particles that make the matrix cloudy proportionally with the aggressiveness of the substance. This phenomenon can be quantified with an optical density spectrophotometer measurement, that according to the protocol, is revelead at 450 nm. Due to the fact that the exposure time is a critical point, a semi-permeable membrane with tailored porosity is used which allows to clearly detect the maximum opacification point. A direct correlation between the Patch test and the scale determined with Dermal Irritection protocol was also determined and used for quantification of the results.
- GLP compliance:
- no
Test material
- Reference substance name:
- see confidential details on test material
- IUPAC Name:
- see confidential details on test material
- Details on test material:
- 100g from sample production (solution at 30% of the test material)
Constituent 1
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: opacity
- Remarks on result:
- other: results are reported in the relevant section
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Conclusions:
- The substance was tested for skin irritation by means of Dermal Irritection Assay. Under the experimental conditions the substance showed slight skin irritation properties.
- Executive summary:
The substance was tested for skin irritation by means of Dermal Irritection Assay. Under the experimental conditions the substance showed slight skin irritation properties.
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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