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Diss Factsheets
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EC number: 201-075-4 | CAS number: 78-00-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Principles of method if other than guideline:
- TEL was investigated in the Ames test on Salmonella typhimurium TA 98, TA 100 and TA 1537
- GLP compliance:
- no
- Remarks:
- test completed before GLP implementation
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat/Hamster liver
- Test concentrations with justification for top dose:
- 1-1000 µg TEL/plate dissolved in DMSO (0/10/33/100/333/1000 µg/Plate)
- Details on test system and experimental conditions:
- Ames test
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- not specified
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Conclusions:
- Interpretation of results: negative
TEL at dose levels of 1-1000 µg/plate in DMSO, proved to be non mutagenic in an Ames test on Salmonella typhimurium TA 98, TA 100 and TA 1537 - Executive summary:
TEL at dose levels of 1-1000 µg/plate in DMSO, proved to be non mutagenic in an Ames test on Salmonella typhimurium TA 98, TA 100 and TA 1537
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
No evidence of mutagenic activity was seen in two good quality Ames tests, using TEL concentrations of 1-1000 µg/plate in DMSO and 1-100 µg/plate in ethanol in Salmonella typhimurium strains TA 98, TA 100 and TA 1537, with and without mammalian metabolic activation (S9) (Mortelmans et al. 1986). A similar study on the analogous substance tetramethyl lead (TML) was also negative (Ames, 1975).
Investigations on Drosophilia melanogaster showed TriEL (a degradation product of TEL) to cause disturbances in nuclear division. (Ramel et al 1979)
Investigations on mice showed at maximally tolerated doses TEL did not promote a dominant lethal response (Kennedy et al 1971)
Justification for classification or non-classification
TEL was negative in two good-quality Ames tests at up to 1000 µg/plate, with and without S9. Investigations on mice showed at maximally tolerated doses TEL did not promote a dominant lethal response Kennedy et al 1971) TEL is not classified as mutagenic in Annex I of the EU DSD or according to CLP regulations.
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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