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EC number: 200-915-7 | CAS number: 75-91-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Near-guideline GLP-compliant study, adequate for evaluation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Principles of method if other than guideline:
- Following an initial toxicity screen, the test substance was tested using L5176Y TK+/- cells in the absence and presence of Aroclor 1254-induced rat S9 fraction (2 day expression period).
- GLP compliance:
- yes
- Remarks:
- QAU compliance statement dated 25 September 1981
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- tert-butyl hydroperoxide
- EC Number:
- 200-915-7
- EC Name:
- tert-butyl hydroperoxide
- Cas Number:
- 75-91-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 2-methylpropane-2-peroxol
- Details on test material:
- - Aqueous solution containing ca. 70wt% TBHP (CAS No. 75-91-2)
- Lot/batch No.: test article #81004
Constituent 1
Method
- Target gene:
- Thymidine kinase locus; TK +/- to TK -/-
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat S9
- Test concentrations with justification for top dose:
- Preliminary toxicity test, with and without S9: 0.001, 0.01, 0.1, 1.0, 10 and 100 ul/ml
Main test, without S9:
Test 1 and Test 2: 0.0013, 0.0018, 0.0024, 0.0032, 0.0042, 0.0056, 0.0075, 0.010 and 0.013 ul/ml;
Test 3: 0.0013, 0.0018, 0.0024, 0.0032, 0.0042, 0.0056, 0.0075, 0.010, 0.013 and 0.018 ul/ml
Main test, with S9:
Test 1: 0.013, 0.018, 0.024, 0.032, 0.042, 0.056, 0.075, 0.10, 0.13 and 0.18 ul/ml
Test 2: 0.018, 0.024, 0.032, 0.042, 0.056, 0.075, 0.10, 0.13, 0.18 and 0.24 ul/ml
Test 3: 0.024, 0.032, 0.042, 0.056, 0.075, 0.10, 0.13, 0.18, 0.24 and 0.32 ul/ml
Comment: purity not reported, all doses nominal
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Positive control substance:
- other: -S9 = ethylmethanesulfonate (0.5 and 1.0 ul/ml); +S9 = 7,12-dimethylbenz(a)anthracene (5.0 or 7.5 ul/ml)
- Evaluation criteria:
- Mutation frequency for the treated plates was compared with that of the control plates. A two-fold increase in mutation frequency was considered to reflect a positive response.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- - consistent findings in all 3 tests
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- - the test concentrations selected to be below threshold for cytotoxicity (0.1 ul/ml without S9, 1 ul/ml with S9)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Test 1 and test 2 were compromised due to a high level of contamination but still demonstrated a positive mutagenic response both in the absence and presence of S9 fraction. These findings were confirmed by test 3, where no contamination was present.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive without metabolic activation
positive with metabolic activation
The test substance was positive in L5178Y TK+/- cells in the absence and in the presence of Aroclor 1254-induced rat S9 fraction. - Executive summary:
The mutagenic potential of TBHP was evaluated in L5178Y TK+/- cells in the absence or presence of Aroclor 1254-induced rat S9 fraction. The investigation was GLP-compliant and followed EU Method B.17, and was repeated three times due to contamination of the initial trials. A positive mutagenic response was recorded on all occasions, both in the absence and presence of S9 fraction. The results demonstrate that TBHP is a mammalian cell mutagen in L5178Y TK+/- cells in vitro.
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