Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
30
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
72 mg/m³
DNEL related information
Overall assessment factor (AF):
22.5

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:
no hazard identified
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

The derivation of DNELs for zinc selenite is described in detail in the DNEL report attached to the technical dossier and to the CSR. The report also includes the justification for not deriving DNELs for certain exposure patterns and the justification for assessment factors for those DNELs derived.

In brief, for workers the long-term DNEL (inhalation, systemic) was derived based on subchronic oral toxicity data in rats and route-to-route extrapolation. The Acute DNEL (inhalation, systemic) was derived based on subchronic oral toxicity data in rats, because peak exposure above the average cannot be ruled out for the work place. The justifications for not derived DNELs for workers are given above.

In addition, endpoint specific DNELs are derived for female fertility based on effects on oestrus cycle length observed in the 90-day oral toxicity study and findings observed in a developmental toxicity study. Because there were also some effects in mice offspring (decreased foetal body weight) at a dose level not showing maternal toxicity, DNELs are also derived for developmental toxicity:

Exposure pattern

DNEL (appropriate unit)

 

Workers

long-term– inhalation, female fertility

Derived based on subchronic oral toxicity data in rats in consideration of results from a developmental toxicity study in mice and route-to-route extrapolation:

ZnSeO3: 1.9 mg/m3

long-term– oral, female fertility

Not required/relevant acc. to ECHA guidance.

long-term- inhalation, developmental toxicity

Derived based on results from a developmental toxicity study in mice and route-to-route extrapolation:

ZnSeO3: 1.9mg/m3

long-term- oral, developmental toxicity

Not required/relevant acc. to ECHA guidance.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
0.15 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
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

The derivation of DNELs for zinc selenite is described in detail in the DNEL report attached to the technical dossier and to the CSR. The report also includes the justification for not deriving DNELs for certain exposure patterns and the justification for assessment factors for those DNELs derived.

In brief, long-term DNEL (oral, systemic effects) was derived for general population based on subchronic oral toxicity data in rats. The justifications for not derived DNELs for the general population are given above.

In addition, endpoint specific DNELs are derived for female fertility based on effects on oestrus cycle length observed in the 90-day oral toxicity study and findings observed in a developmental toxicity study. Because there were also some effects in mice offspring (decreased foetal body weight) at a dose level not showing maternal toxicity, DNELs are also derived for developmental toxicity.

Exposure pattern

DNEL (appropriate unit)

General population

long-term– inhalation, female fertility

Not required: overall there is no reason of concern related to female fertility following inhalation for the general population, because no relevant exposure must be expected.

long-term– oral, female fertility

Derived based on subchronic oral toxicity data in rats in consideration of results from a developmental toxicity study in mice:

ZnSeO3:0.16 mg/kg bw/d

long-term- inhalation, developmental toxicity

Not required: overall there is no reason of concern related to female fertility following inhalation for the general population, because no relevant exposure must be expected.

long-term- oral, developmental toxicity

Derived based on results from a developmental toxicity study in mice:

ZnSeO3:0.29 mg/kg bw/d