Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.47 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):
130
Dose descriptor starting point:
NOAEL
Value:
230.7 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
406.76 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of ammonium (Amm), i.e. expressed as mg Amm/kg bw/day and mg Amm/m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg ZrCompl/m³". Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2.6
Justification:
70 days to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default, rat
AF for other interspecies differences:
2.5
Justification:
ECHA default, remaining differences
AF for intraspecies differences:
5
Justification:
ECHA default, worker
AF for the quality of the whole database:
1
Justification:
key study available
AF for remaining uncertainties:
1
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
1.97 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):
130
Dose descriptor starting point:
NOAEL
Value:
230.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The same bioavailability is assumed for humans and animals, thus no modification required (in accordance with ECHA Guidance R.8, Chapter R.8.4, page 17ff.).

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of ammonium (Amm), i.e. expressed as mg Amm/kg bw/day. The DNEL is given on a substance specific basis, i.e. expressed as "mg ZrCompl/kg bw/day".

Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2.6
Justification:
70 days to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default, rat
AF for other interspecies differences:
2.5
Justification:
ECHA default, remaining differences
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
key study available
AF for remaining uncertainties:
1
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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

In order to evaluate toxicological properties of the substance zirconium, acetate lactate oxo ammonium complexes, information on the assessment entities zirconium and ammonium cations as well as acetate and lactate anions were considered. For a documentation and justification of that approach, please refer to the separate document attached to section 13, namely Read Across Assessment Report for zirconium, acetate lactate oxo ammonium complexes.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.86 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):
260
Dose descriptor starting point:
NOAEL
Value:
230.7 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
200.61 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of ammonium (Amm), i.e. expressed as mg Amm/kg bw/day and mg Amm/m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg ZrCompl/m³". Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2.6
Justification:
70 days to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default, rat
AF for other interspecies differences:
2.5
Justification:
ECHA default, remaining differences
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
key study available
AF for remaining uncertainties:
1
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
0.98 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):
260
Dose descriptor starting point:
NOAEL
Value:
230.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The same bioavailability is assumed for humans and animals, thus no modification required (in accordance with ECHA Guidance R.8, Chapter R.8.4, page 17ff.).

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of ammonium (Amm), i.e. expressed as mg Amm/kg bw/day. The DNEL is given on a substance specific basis, i.e. expressed as "mg ZrCompl/kg bw/day".

Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2.6
Justification:
70 days to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default, rat
AF for other interspecies differences:
2.5
Justification:
ECHA default, remaining differences
AF for intraspecies differences:
10
Justification:
ECHA default, general population
AF for the quality of the whole database:
1
Justification:
key study available
AF for remaining uncertainties:
1
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
0.98 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):
260
Dose descriptor starting point:
NOAEL
Value:
230.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of ammonium (Amm), i.e. expressed as mg Amm/kg bw/day. The DNEL is given on a substance specific basis, i.e. expressed as "mg ZrCompl/kg bw/day".

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2.6
Justification:
70 days to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default, rat
AF for other interspecies differences:
2.5
Justification:
ECHA default, remaining differences
AF for intraspecies differences:
10
Justification:
ECHA default, general population
AF for the quality of the whole database:
1
Justification:
key study available
AF for remaining uncertainties:
1
Justification:
ECHA default
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

In order to evaluatetoxicological properties of the substance zirconium, acetate lactate oxo ammonium complexes, information on the assessment entities zirconium and ammonium cations as well as acetate and lactate anions were considered. For a documentation and justification of that approach, please refer to the separate document attached to section 13, namely Read Across Assessment Report for zirconium, acetate lactate oxo ammonium complexes.