Registration Dossier
Registration Dossier
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EC number: 295-421-1 | CAS number: 92045-40-4 A complex combination of hydrocarbons obtained by distillation of used lubricating oils. It boils in the range of approximately 80°C to 365°C (176°F to 689°F).
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Principles of method if other than guideline:
- This in vitro study was performed in order to evaluate the potential of Lubricating oils, used, distd. / Distillato leggero to evoke skin irritation in a reconstructed human epidermis (RhE) test method.
Skin irritation refers to the production of reversible damage to the skin following the appli-cation of a test chemical.
The test consists of a topical exposure of the neat test item to a human reconstructed epi-dermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide, present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percentage reduction of cell viability in comparison of untreated nega-tive controls is used to predict the skin irritation potential. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lubricating oils, used, distd.
- EC Number:
- 295-421-1
- EC Name:
- Lubricating oils, used, distd.
- Cas Number:
- 92045-40-4
- IUPAC Name:
- Lubricating oils, used, distillated
- Test material form:
- other: liquid
- Details on test material:
- Representative sample of the substance.
Constituent 1
Test system
- Controls:
- yes
- Duration of treatment / exposure:
- 60 minutes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Optical density
- Value:
- 1.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Lubricating oils, used, distd. / Distillato leggero is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) test method.
According to CLP regulation, the substance should not be classified as skin irritant.
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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