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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-075-4 | CAS number: 78-00-2
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.16 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 12 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation needed - adequate experimental data are available on the relevant route of exposure
- AF for dose response relationship:
- 3
- Justification:
- Default AF for use of an LOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for sub-chronic to chronic duration of exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default AF - Allometric scaling is not applied in the derivation of the inhalation DNEL. In that case, differences in the allometry are assumed to be compensated by differences in the respiration rate
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for intraspecies differences for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
- AF for remaining uncertainties:
- 1
- Justification:
- Default AF
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.681 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 248.75
- Modified dose descriptor starting point:
- other: LC50
- Value:
- 850 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation needed - adequate experimental data are available on the relevant route of exposure
- AF for dose response relationship:
- 99.9
- Justification:
- Max AF for use of an LC50
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default AF - Allometric scaling is not applied in the derivation of the inhalation DNEL. In that case, differences in the allometry are assumed to be compensated by differences in the respiration rate
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for intraspecies differences for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
- AF for remaining uncertainties:
- 1
- Justification:
- Default AF
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.001 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 0.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- As no data on the effects of repeated dermal exposure to TEL in humans or laboratory animals were available, route-to-route extrapolation to calculate a DNEL for such effects from repeated dose oral toxicity studies was considered a suitable alternative. In the absence of experimental data it was assumed that there was no first-pass metabolism. Default absorption factor for oral-to-dermal extrapolation: 1 Modification factor: 1 Exposure conditions Time scaling: not applicable Modification factor: 1 Overall modification factor: 1 x 1 x 1 = 1
- AF for dose response relationship:
- 3
- Justification:
- Default AF for use of an LOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for sub-chronic to chronic duration of exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rat for toxicokinetic differences in metabolic rate (allometric scaling)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for intraspecies differences for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
- AF for remaining uncertainties:
- 1
- Justification:
- Default AF
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.13 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 175
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 547 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation needed - adequate experimental data are available on the relevant route of exposure
- AF for dose response relationship:
- 10
- Justification:
- Default maximum AF for use of an LOAEL with severe effects (death)
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- Default AF for dog for toxicokinetic differences in metabolic rate (allometric scaling)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for intraspecies differences for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
- AF for remaining uncertainties:
- 1
- Justification:
- Default AF
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 12 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation needed - adequate experimental data are available on the relevant route of exposure
- AF for dose response relationship:
- 3
- Justification:
- Default AF for use of an LOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for sub-chronic to chronic duration of exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default AF - Allometric scaling is not applied in the derivation of the inhalation DNEL. In that case, differences in the allometry are assumed to be compensated by differences in the respiration rate
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for intraspecies differences for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
- AF for remaining uncertainties:
- 1
- Justification:
- Default AF
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.34 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 2 497.5
- Modified dose descriptor starting point:
- other: LC50
- Value:
- 850 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation needed - adequate experimental data are available on the relevant route of exposure
- AF for dose response relationship:
- 99.9
- Justification:
- Max AF for use of an LC50
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default AF - Allometric scaling is not applied in the derivation of the inhalation DNEL. In that case, differences in the allometry are assumed to be compensated by differences in the respiration rate
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for intraspecies differences for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
- AF for remaining uncertainties:
- 1
- Justification:
- Default AF
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
The general population do not come into contact with TEL.
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.
