Registration Dossier
Registration Dossier
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EC number: 690-680-0 | CAS number: 19358-05-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU/OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2-dimethyl-4-methylidene-1,3-dioxolane
- EC Number:
- 690-680-0
- Cas Number:
- 19358-05-5
- Molecular formula:
- C6H10O2
- IUPAC Name:
- 2,2-dimethyl-4-methylidene-1,3-dioxolane
Constituent 1
Results and discussion
In vivo
Results
- Irritation parameter:
- other: cytotoxicity to in the EPISKIN assay
- Basis:
- other: viability in the MTT assay
- Time point:
- other: 3 minutes, 1 hour and/or 4 hours
- Score:
- > 39
- Reversibility:
- no data
- Remarks on result:
- other: cell viability 65, 1% and 90,9% and 39,7%
- Irritant / corrosive response data:
- Following exposure with the test item for 3 minutes, 1 hour and 4 hours, the mean cell
viability was 65.1, 90.9 and 39.7%, respectively, when compared to the relevant
negative control (after adjustment for non-specific MTT reduction). Based on the
observed mean relative viability values the test item was considered as being noncorrosive.
The experiments met the validity criteria; therefore, the overall study was
considered to be valid.
Applicant's summary and conclusion
- Interpretation of results:
- other: not skin corrosive
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- Following exposure with BCS-CL73507-BCS-BS22576 (MYDO) for 3 minutes,
1 hour and 4 hours, the mean cell viability was 65.1, 90.9 and 39.7%, respectively,
when compared to the relevant negative control value (after adjustment for nonspecific
MTT reduction). Although in one of 5 discs a positive signal (<35% viability)
was detected for an individual sample in case of the 4 hours treatment, based on the
observed mean relative viability values the test item was considered as being noncorrosive.
The experiments met the validity criteria, therefore the overall study was
considered to be valid. - Executive summary:
In conclusion, in this in vitro EPISKIN model test with BCS-CL73507-BCSBS22576 (MYDO), the results indicate that the test item is not a skin corrosive.
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