[No public or meaningful name is available]

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

21 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):

100

Dose descriptor starting point:

NOAEL

Value:

210 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

2 100 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation taking into account that dermal absorption is set at 10%, while oral absorption is set at 100% (see toxicokinetic assessment) leads to the NOAEL of 2100 mg/kg bw that is taken as starting point for the calculation of the DNEL.

AF for dose response relationship:

1

AF for differences in duration of exposure:

2

Justification:

subchronic to chronic

AF for interspecies differences (allometric scaling):

4

Justification:

species tested is the rat

AF for other interspecies differences:

2.5

Justification:

default value

AF for intraspecies differences:

5

Justification:

worker exposure

AF for the quality of the whole database:

1

Justification:

based on guideline study under GLP

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:

low hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

10.5 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):

200

Dose descriptor starting point:

NOAEL

Value:

210 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

2 100 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation taking into account that dermal absorption is set at 10%, while oral absorption is set at 100% (see toxicokinetic assessment) leads to the NOAEL of 2100 mg/kg bw that is taken as starting point for the calculation of the DNEL.

AF for dose response relationship:

1

Justification:

the safety factor for extrapolation from LOAEL to NOAEL has already been included in the starting NOAEL

AF for differences in duration of exposure:

2

Justification:

subchronic to chronic

AF for interspecies differences (allometric scaling):

4

Justification:

The species tested is the rat

AF for other interspecies differences:

2.5

Justification:

default value

AF for intraspecies differences:

10

Justification:

consumer exposure

AF for the quality of the whole database:

1

Justification:

Based on guidelines study under GLP

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:

low hazard (no threshold derived)

DNEL related information

Justification:

not applicable

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:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified