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EC number: 941-245-1 | CAS number: 1689576-43-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study according to current guidelines but reported as summary report, non GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): 2-(2-Methylallyl)-cyclododecanon-Rein
- Physical state: Liquid/ colorless, clear
- Analytical purity: 99.3 area-% (not corrected with the water content), Capillary GC-analysis
- Lot/batch No.: 2-(2-Meth-allyl)cyclododecanon (MACD Probe aus B410.16 vom 04.10.2012)
- Storage condition of test material: Room temperature
- pH value: approx. 5
- Direct MTT reduction: no
Constituent 1
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- 50 μL (corrosion test) or 30 μL (irritation test)
- Duration of treatment / exposure:
- 3 minutes and 1 hour (corrosion test)
1 hour with 42 hours postincubation (irritation test) - Observation period:
- 3 minutes and 1 hour (corrosion test)
1 hour with 42 hours postincubation (irritation test) - Number of animals:
- not applicable
- Details on study design:
- The test consists of a single topical exposure of 50 μL (corrosion test) or 30 μL (irritation test) of the test substance to the surface of a human reconstituted epidermis model for 3 minutes and 1 hour (corrosion test) or 1 hour with 42 hours postincubation (irritation test) followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of the yellow, water-soluble MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide), present in cell mitochondria, into a blue formazan salt that is measured quantitatively after isopropanol -
extraction from the tissues. The optical density of the extracts of test substance treated tissues is compared to negative control values from tissues treated with de-ionized water or PBS and is expressed as relative tissue viability.
Negative control: de-ionized water (corrosion test)/PBS, sterile (irritation test)
Positive control: 8 N KOH (corrosion test) / 5% SDS in de-ionized water, sterile (irritation test)
Number of tissues used: 2 per exposure period (corrosion test); 3 (irritation test).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: tissue viability
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 98
- Reversibility:
- other: not applicable
- Remarks on result:
- other: % viability of negative control; Corrosion Test
- Irritation parameter:
- other: tissue viability
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 115
- Reversibility:
- other: not applicable
- Remarks on result:
- other: % viability of negative control; Corrosion Test
- Irritation parameter:
- other: tissue viability
- Basis:
- mean
- Time point:
- other: 1 hour + 42 hours postincubation
- Score:
- 101
- Reversibility:
- other: not applicable
- Remarks on result:
- other: % viability of negative control; Irritation Test
Any other information on results incl. tables
The positive control led to 17% and 9% viability of the negative control after 3 min and 1h exposure in the corrosion test, respectively.
The positive control led to 4% viability of the negative control in the irritation test.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The present data on skin irritation do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.
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