Registration Dossier

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
DNEL 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
DNEL 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
DNEL 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
DNEL 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
DNEL 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
DNEL 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.