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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
Description of key information
The key study and the key value for CSA for Oral toxicity was completed on rats. Several supporting studies at higher doses support the quoted LOAEL for Repeated Dose Oral Toxicity.
A waiver has been submitted for repeated dose dermal toxicity testing
Two repeat inhalation toxicity conducted by Davis on rats and beagles gave very similar conclusions with LOAEC levels of 12 mg/m3. LD100 values are also reported and differ for the two species, with a value of 22 mg/m3 quoted for rats and 12 mg/m3 for the dogs
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- No data on the exact method used is available
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Animals kept in cages. Test conditions: 22 degrees C, 50% relative humidity, 12 hours light, food and water ad libitum
5 Animals per group - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration of treatment / exposure:
- 13 Weeks
- Frequency of treatment:
- 5 times per week
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 0.2 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 Animals per dose
- Control animals:
- yes, concurrent vehicle
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At low dose and high dose, reduced body weight
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- At low dose and high dose, reduced feed intake
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Dry / Haematological: low dose - Amino laevulinicacid dehydrogenase high dose - not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- excitability, irritability, tremors, coma
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At low and high dose: brain lesions and spinal cord, eosinophilic inclusions in prox. Renal tubular
- Dose descriptor:
- LOAEL
- Effect level:
- 0.2 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- Critical effects observed:
- not specified
- Conclusions:
- Repeat oral toxicity study carried out on groups of male rats, concluded that the first signs of toxicological effects due to TEL were observed at a dose rate of 0.2 mg/kg bw/d.
- Executive summary:
Repeat oral toxicity study carried out on groups of male rats, concluded that the first signs of toxicological effects due to TEL were observed at a dose rate of 0.2 mg/kg bw/d.
An additional early study (21 weeks, oral, rats) by Schepers (1964b) supports the LOAEL identified in Franklin et al. (1987).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 0.2 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEC
- 12 mg/m³
- Study duration:
- subchronic
- Species:
- dog
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key study chosen for repeated dose oral toxicity was the robust subchronic (13-week) toxicity study in rats, which identified a LOAEL of 0.2 mg/kg bw/day (Franklin et al. 1987). An additional early study (21 weeks, oral, rats) by Schepers (1964b) supports the LOAEL identified in Franklin et al. (1987). Although there is a 6 month study in rhesus monkeys (Heywood et al. 1979) that identified a NOAEL of 0.009 mg/kg bw/day, only this single low dose was administered for a limited portion of the animals lifetime (which is generally up to 20 years).
A testing waiver has been submitted for a repeated dose dermal toxicity test
Two repeat inhalation toxicity studies conducted on rats and beagles gave LOAEC levels of 22 mg/m3 for rats (Davies et al. 1963a) and 12 mg/m3 for dogs (Davies et al. 1963a). LD100 values are also reported and differ for the two species, with a value of 22 mg/m3 quoted for rats and 12 mg/m3 for the dogs. The values for dogs are used for the purposes of the CSA.
Justification for selection of repeated dose toxicity dermal -
systemic effects endpoint:
It is proposed to waive this test. Exhaustive repeated dose testing
has shown TEL to be highly toxic by all other routes with various
species. The substance is classified as very toxic (T+) by ingestion,
inhalation and absorption through the skin.
Justification for classification or non-classification
TEL is classified in Annex I of the EU DSD as R33 (Danger of cumulative effects) and as STOT Rep. Exp. 2 (H373: May cause damage to organs through prolonged or repeated exposure) according to EU 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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