Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
DNEL value:
31.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conducted according to Appendix R8.2 of the ECHA Guidance document "Chapter R.8: Characterisation of dose [concentration]-response for human"
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute -> chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Still applied by route to route extrapolation for deriving NOAEC by using allometric scaling
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
Default value according to ECHA REACH Guidance
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 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:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conduted according to Health Risk Assessment Guidance for Metals (HERAG).
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute -> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat-> human; Default value according to ECHA REACH Guidance
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
Default value according to ECHA REACH Guidance
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The derivation of DNELs is based on available toxicological data and the toxicokinetic behaviour of tellurium compounds. A testing proposal on repeated dose toxicity is included and thus the current DNELs should be considered as preliminary. Based on the outcome of the proposedSub-Chronic Oral Toxicity Test (Repeated Dose 90-Day Oral Toxicity Study in Rodents) the derivation will be reevaluated.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
DNEL value:
15.75 mg/m³
Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conducted according to Appendix R8.2 of the ECHA Guidance document "Chapter R.8: Characterisation of dose [concentration]-response for human"
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute->chronic, default value according to ECHA REACH Guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Still applied by route to route extrapolation for deriving NOAEC by using allometric scaling
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
Default value according to ECHA REACH Guidance
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 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):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conduted according to Health Risk Assessment Guidance for Metals (HERAG).
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
subacute->chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat-> human, default value according to ECHA REACH Guidance
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
Default value according to ECHA REACH Guidance
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 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):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
18 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute->chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat->human, default value according to ECHA REACH Guidance
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
Default value according to ECHA REACH Guidance
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population