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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 941-253-5 | CAS number: 1689576-41-7
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:
- 2-Methyl-4,5,6,7,8,9,10,11,12,13-decahydro- 1H-cyclopentacyclododecen
- IUPAC Name:
- 2-Methyl-4,5,6,7,8,9,10,11,12,13-decahydro- 1H-cyclopentacyclododecen
- Details on test material:
- - Name of test material (as cited in study report): 2-Methyl-4,5,6,7,8,9,10,11,12,13-decahydro-1 H-cyclopentacyclododecen
- Physical state: Liquid/ brown, turbid
- Analytical purity: 62.5 area-% (not corrected for the water content.)
- Lot/batch No.: Methyl-Cyclopentadien-Cyclododecan (Austrag Gasphase SVA-Fabrik 02-18.10.2012)
- 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:
- 105
- 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:
- 113
- 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 21% and 7% mean 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
