Registration Dossier
Registration Dossier
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EC number: 942-177-5 | CAS number: -
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Plastic, waste, pyrolized, distn., oil
- Molecular formula:
- Not applicable
- IUPAC Name:
- Plastic, waste, pyrolized, distn., oil
- Test material form:
- liquid
- Details on test material:
- Substance manufactured by the lead registrant according to the third compostion included in the registration dossier of Plastic, waste, pyrolized, fractionation bottoms (Raw Diesel)
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The test system is a commercially available EpiDermTM-Kit
- Vehicle:
- Hank's balanced salt solution
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts. - Control samples:
- other: DPBS-buffer was used as negative control and 5% SDS solution was used as positive control
- Duration of treatment / exposure:
- the tissues were set in the incubator for 23 hours and 15 minutes at 37 ± 1°C and 5.0 ± 1% CO2 and ≥ 95% relative humidity
- Number of replicates:
- 2
Test animals
- Species:
- other: human
Test system
- Type of coverage:
- occlusive
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 1
- Value:
- ca. 87.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 2
- Value:
- ca. 95.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 3
- Value:
- ca. 99
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- ca. 93.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- TACOIL is neither irritant nor corrosive to the skin.
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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