Registration Dossier
Registration Dossier
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: 265-054-1 | CAS number: 64741-53-3 A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data reported
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was carried out in a method similar to OECD TG 471 with modifications.
Data source
Reference
- Reference Type:
- publication
- Title:
- Estimation of the dermal carcinogenic activity of petroleum fractions using a modified Ames assay
- Author:
- Blackburn, C.R., Deitch, R.A., Schreiner, C.A., Mehlman, M.A., Mackerer, C.R.
- Year:
- 1 984
- Bibliographic source:
- Cell Biology and Toxicology, Volume 1, No. 1
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- with modifications
- Principles of method if other than guideline:
- Method: other: procedure described in paper by Blackburn et al. (see Reference)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Unrefined light paraffinic oil (CAS # 64741-50-0)
- IUPAC Name:
- Unrefined light paraffinic oil (CAS # 64741-50-0)
- Details on test material:
- Light paraffinic distillate, CAS No. 64741-50-0
Designated as Sample#3 in study report.
IUCLID4 Test substance: other TS
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- other: Modified Ames Test using Salmonella typhimurium strain TA 98 and Aroclor 1254-induced rat or hamster liver S-9
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with
- Metabolic activation system:
- Aroclor 1254-induced rat or hamster liver S9
- Test concentrations with justification for top dose:
- Range of doses that provided an initial linear dose response; specific doses not stated.
- Vehicle / solvent:
- No data reported.
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- benzo(a)pyrene at 5 ug/plate and 2-aminoanthracene at 2 ug/plate
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- The light paraffinic distillate was extracted with dimethylsulphoxide by performing five successive one-to-one extractions and pooling extracts. The pooled extract sample was stored at 4 degrees Celsius in an amber bottle until assayed.
- Evaluation criteria:
- A tangent to the dose-response curve at zero dose was constructed to provide the Mutagenicity Index.
- Statistics:
- A tangent to the dose-response curve at zero dose was constructed to provide the Mutagenicity Index.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Modified Ames Test using Salmonella typhimurium strain TA 98 and Aroclor 1254-induced hamster liver S-9
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test substance was not mutagenic in standard assay, but extraction with DMSO produced a mutagenic response. The mutagenicity index was 17. This compares with values of 0 for a solvent refined oil and 40 for a cracked distillate.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
DMSO-extracted light paraffinic distillate was classified as mutagenic and produced a mutagenicity index of 17. Assay sensitivity (the number of TA98 revertants per plate) improved with 8-fold increase of S9. - Executive summary:
- In a modified in vitro mutagenicity assay, S. typhimurium strain TA98 was exposed to a DMSO-extracted light paraffinic distillate at a concentration of 50 microlitres per plate with metabolic activation (Aroclor 1254 -induced rat or hamster liver S9) using the standard pre-incubation method. The test substance was considered mutagenic and produced a mutagenicity index of 17. This study received a Klimisch score of 1 and is classified as reliable without restriction by the CONCAWE Consortium because it was carried out in a method similar to OECD TG 471 with modifications.
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.
