Registration Dossier
Registration Dossier
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EC number: 220-744-1 | CAS number: 2885-00-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Actual occupational exposure data.
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Study period:
- Over 18 years of monitoring and recording of production activities.
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- This evidence has been collected over 16 years of continual production manufacturing up to 100 tonnes per annum.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Report based on 16 years of production of ODM for production up to 100 tonnes per annum.
- GLP compliance:
- no
- Justification for non-LLNA method:
- Study uses human exposure data generated over a 16 year period of production of ODM.
Test material
- Reference substance name:
- Octadecane-1-thiol
- EC Number:
- 220-744-1
- EC Name:
- Octadecane-1-thiol
- Cas Number:
- 2885-00-9
- Molecular formula:
- C18H38S
- IUPAC Name:
- octadecane-1-thiol
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- Production exposure data over a 16 year period.
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Homo-sapien
- Sex:
- male/female
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: Occupation Health Exposure
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The data is based on actual exposure data which has been compiled over 16 years of production. As the material is handled in a molten state there has been documented incidences of skin irritation effects but no evidence of skin sensitisation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Over an 18 year period ther have been four incidences of reported skin irritation effects for production on-site:
2003 - 1 reported incidence
2005 - 1 reported incidence
2006 - 2 reported incidences
All other years up to and including 2018 have reported no incidences of skin irritation effects. The material is handled molten and the effects reported were temporary and deemed to be mild irritation effects. There was no reoccurance for any one spefic individual and there were no successive incidents of increasing adverse effects from exposure to molten ODM during normal operational procedures. It can be concluded that ODM is a weak skin irritant and has demonstrated no skin (or respiratory) sensitisation effects.
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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