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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-861-0 | CAS number: 26635-64-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: TA 98, TA100, TA1535, TA1537, TA1538
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results:
negative
Under the test conditions, the experimental compound, 2,2,4-trimethylpentane, did not exhibit a positive response and is, therefore, considered not be mutagenic in this system. - Executive summary:
This data is being read across from the source study that tested 2,2,4-trimethylpentane based on analogue read across.
Under the test conditions, the experimental compound, 2,2,4-trimethylpentane, did not exhibit a positive response and is, therefore, considered not be mutagenic in this system.
TA98: Revertants Test
| Test substance | Test 1 (without S9) | Test 2 (without S9) | Test 1 (with S9) | Test 2 (with S9) |
| solvent control | 22 -26 | 22 -26 | 22 -26 | 18 -20 |
| 2 -Nitrofluorene | 1508 -1637 | 2131 -2282 | - | - |
| 2 -Aminoanthracene | - | - | 2213 -2247 | 1913 -2020 |
| 7 µg/plate isooctane | - | 15 -27 | - | 24 -46 |
| 20 µg/plate isooctane | 140 -191 | 19 -23 | 145 -206 | 29 -31 |
| 60 µg/plate isooctane | 112 -124 | 19 -26 | 64 -117 | 24 -33 |
| 190 µg/plate isooctane | 37 -55 | 19 -24 | 17 -28 | 12 -25 |
Retest (test 2) of TA98 without and with S9 at dose levels for 7, 20 and 60 µg/plate evidenced no difference from solvent controls.
Observed 5 -10 fold increase of TA98 revertants without and with S9 at 20 and 60 µg/plate in initial test was not confirmed in retest of TA98 without and with S9 at dose levels 7, 20 and 60 µg/plate.
In all experiments, no increase in revertants for other frame shift strains (TA1537 and TA 1538) was observed. Therefore the in test 1 observed genotoxic effects of isooctane in strain TA 98 were rather false positive.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- - no A-T base pair tester strains included (e.g. TA102 or E.coli); limited documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- yes
- Remarks:
- - no A-T base pair tester strains included (e.g. TA102 or E.coli); limited documentation
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2,4-trimethylpentane
- EC Number:
- 208-759-1
- EC Name:
- 2,2,4-trimethylpentane
- Cas Number:
- 540-84-1
- Molecular formula:
- C8H18
- IUPAC Name:
- 2,2,4-trimethylpentane
- Details on test material:
- - Name of test material (as cited in study report): Isooctane
- Analytical purity: 100% pure commercial product
- Other: Solubility: Results suggest that a homogeneous suspension can be achieved at approximately 50 mg/mL of DMSO.
Constituent 1
Method
- Target gene:
- his-operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA100, TA1535, TA1537, TA1538
- Details on mammalian cell type (if applicable):
- no data
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomes from male Sprague Dawley rats treated with a single intraperitoneal injection of Aroclor 1254 5-days before sacrifice.
- Test concentrations with justification for top dose:
- 20, 60, 560, 1670, and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: N-methl-N'-nitro-N-nitrosoguanidine
- Remarks:
- positive control for TA100 and TA1535 (5 µg/plate)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- positive control for TA98 and TA1538 (50 µg/plate) - in absence of S9-mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- positive control for TA1537 (75 µg/plate)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: TA 98, TA100, TA1535, TA1537, TA1538
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
TA98: Revertants Test
| Test substance | Test 1 (without S9) | Test 2 (without S9) | Test 1 (with S9) | Test 2 (with S9) |
| solvent control | 22 -26 | 22 -26 | 22 -26 | 18 -20 |
| 2 -Nitrofluorene | 1508 -1637 | 2131 -2282 | - | - |
| 2 -Aminoanthracene | - | - | 2213 -2247 | 1913 -2020 |
| 7 µg/plate isooctane | - | 15 -27 | - | 24 -46 |
| 20 µg/plate isooctane | 140 -191 | 19 -23 | 145 -206 | 29 -31 |
| 60 µg/plate isooctane | 112 -124 | 19 -26 | 64 -117 | 24 -33 |
| 190 µg/plate isooctane | 37 -55 | 19 -24 | 17 -28 | 12 -25 |
Retest (test 2) of TA98 without and with S9 at dose levels for 7, 20 and 60 µg/plate evidenced no difference from solvent controls.
Observed 5 -10 fold increase of TA98 revertants without and with S9 at 20 and 60 µg/plate in initial test was not confirmed in retest of TA98 without and with S9 at dose levels 7, 20 and 60 µg/plate.
In all experiments, no increase in revertants for other frame shift strains (TA1537 and TA 1538) was observed. Therefore the in test 1 observed genotoxic effects of isooctane in strain TA 98 were rather false positive.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
Under the test conditions, the experimental compound, 2,2,4-trimethylpentane, did not exhibit a positive response and is, therefore, considered not be mutagenic in this system. - Executive summary:
Under the test conditions, the experimental compound, 2,2,4-trimethylpentane, did not exhibit a positive response and is, therefore, considered not be mutagenic in this system.
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.
