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EC number: 202-675-9 | CAS number: 98-51-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
IN VITRO
In a reverse gene mutation assay in bacteria (Hüls AG, 1987), strains TA1535, TA1537, TA1538, TA98 and TA100 of S. typhimurium were exposed to p-tert.-Butyltoluene (purity not given) in DMSO at concentrations of 10-5000 µg/plate in the presence and absence of mammalian metabolic activation (standard plate test and preincubation test). The study was conducted in accordance with OECD TG 471.
p-tert.-Butyltoluene was tested up to cytotoxic concentrations. The positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
The results of this key study are confirmed by other mutagenicity tests.
In a reverse gene mutation assay in bacteria (Dean et al, 1985), strains TA98, TA100, TA1535, TA1537 and TA1538 of S. typhimurium and strains WP2 and WP2 uvrA of E. coli were exposed to p-tert-butyltoluene (purity 96%) in DMSO and hexane at concentrations of 0.2, 2, 20, 50 and 2000 µg/plate in the presence and absence of mammalian metabolic activation (preincubation test).
No information is given on cytotoxicity. The positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data, with exception of the data on cytotoxicity lacking in the publication.
In another reverse gene mutation assay in bacteria (Zeiger et al, 1987), strains TA98, TA100, TA1535 and TA1537 of S. typhimurium were exposed to p-tert-butyltoluene (purity 98%) in DMSO at concentrations of 0.3, 1, 3.3, 10, 33, 100, 333, 1000 µg/plate in the presence and absence of mammalian metabolic activation (preincubation test).
p-tert-butyltoluene) was tested up to cytotoxic concentrations. The positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
In a rather poorly documented, mammalian cell cytogenetic assay (Chromosome aberration) (Dean et al, 1985), RL4 rat liver epithelial cell cultures were exposed to p-tert-butyltoluene (purity 96%) at concentrations of equivalent to 0.5, 0.25 and 0.125- fold of IC50 (concentration inhibiting cell growth by 50%, not further stated) without metabolic activation.
p-tert-Butyltoluene was tested up to cytotoxic concentration.
There was no evidence of chromosome aberration induced over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 473 for in vitro cytogenetic mutagenicity data, with exception of the documentation deficiencies in the publication.
IN VIVO
No data are available on genotoxicity of p-tert-butyltoluene in experimental animals.
p-tert.Butylbenzoic acid, an analogous compound and metabolite of p-tert-butyltoluene in rats, did not induce chromosomal aberrations in rats after oral administration (BG Chemie, 2000).
In this cytogenetic assay (BG Chemie, 2000) Wistar rats (groups of 6/sex) were treated orally with p-tert.butylbenzoic acid (99.8% pure) at doses of 0, 300, 600 mg/kg bw (single dosing). Bone marrow cells were harvested at 24 and 48 hours post-treatment. The vehicle was corn oil. The study was conducted in accordance with OECD TG 475 and GLP guidelines.
Two high dose males died. A weak reduction (females only) of the mitotic indices after treatment with the test item was observed at preparation interval 24 hours indicating a cytotoxic effectiveness of the test item. No statistically significant increase in the frequency of aberrant cells occurred after treatment with the test item as compared to the vehicle control.
Tert.butylbenzoic acid was tested at an adequate dose. The positive control induced the appropriate response.
There was not a significant increase in the frequency of chromosomal aberrations in bone marrow cells after any treatment time.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 475 for in vivo cytogenetic mutagenicity data.
Short description of key information:
IN VITRO
Not mutagenic in bacteria.
Not clastogenic in rat liver cells.
IN VIVO
No data are available.
Endpoint Conclusion:
Justification for classification or non-classification
There is no need to classify 4-tert.-butyltoluene for mutagenicity according to the Directive 67/548/EC or GHS criteria.
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