Menthane, monohydroperoxy derivative

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Value:

0.62 mg/m³

Most sensitive endpoint:

irritation (respiratory tract)

Route of original study:

By inhalation

DNEL related information

DNEL derivation method:

other: Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health ver 2, Dec. 2010

Overall assessment factor (AF):

50

Modified dose descriptor starting point:

NOAEC

Value:

31 mg/m³

Explanation for the modification of the dose descriptor starting point:

local effects at the site of exposure

AF for dose response relationship:

1

Justification:

study indicates both NOAEC and LOAEC

AF for differences in duration of exposure:

2

Justification:

sub-chronic to chronic (based on 90-day study)

AF for interspecies differences (allometric scaling):

1

Justification:

local effect primary effect

AF for other interspecies differences:

2.5

Justification:

identical to that used for systemic effects

AF for intraspecies differences:

5

Justification:

factor for workers considered worst case as no species difference was seen in dermal studies with rats and mice

AF for the quality of the whole database:

2

Justification:

NOAEC based on a study with a structural analogue

AF for remaining uncertainties:

1

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

DNEL extrapolated from long term DNEL

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.62 mg/m³

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

DNEL derivation method:

other: Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health ver 2, Dec. 2010

Overall assessment factor (AF):

50

Dose descriptor:

NOAEC

AF for dose response relationship:

1

Justification:

study indicates both NOAEC and LOAEC

AF for differences in duration of exposure:

2

Justification:

sub-chronic to chronic (based on 90-day study)

AF for interspecies differences (allometric scaling):

1

Justification:

local effect primary effect

AF for other interspecies differences:

2.5

Justification:

identical to that used for systemic effects

AF for intraspecies differences:

5

Justification:

factor for workers considered worst case as no species difference was seen in dermal studies with rats and mice

AF for the quality of the whole database:

2

Justification:

NOAEC based on a study with a structural analogue

AF for remaining uncertainties:

1

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:

low hazard (no threshold derived)

Value:

0.15 mg/kg bw/day

Most sensitive endpoint:

skin irritation/corrosion

Route of original study:

Dermal

DNEL related information

DNEL derivation method:

other: Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health ver 2, Dec. 2010

Overall assessment factor (AF):

20

Modified dose descriptor starting point:

NOAEL

Value:

3 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

not justified, because the primary effect is a local effect

AF for dose response relationship:

1

Justification:

90-day study with NOAEL and LOAEL

AF for differences in duration of exposure:

2

Justification:

sub-chronic to chronic

AF for interspecies differences (allometric scaling):

1

Justification:

primary effect is local effect

AF for other interspecies differences:

1

Justification:

mechanism destruction of membranes

AF for intraspecies differences:

5

Justification:

factor for workers considered worst case as no species difference was seen in dermal studies with rats and mice

AF for the quality of the whole database:

2

Justification:

NOAEL based on a study with a structural analogue

AF for remaining uncertainties:

1

Acute/short term exposure

Hazard assessment conclusion:

no DNEL required: short term exposure controlled by conditions for long-term

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3 µg/cm²

Most sensitive endpoint:

skin irritation/corrosion

DNEL related information

DNEL derivation method:

other: based on NOAEL of 3 mg/kg bw (0.15% or 0.009 mg/cm2)

Overall assessment factor (AF):

3

Dose descriptor:

other: NOAEL

AF for dose response relationship:

1

Justification:

90-day study with NOAEL and LOAEL

AF for differences in duration of exposure:

1

Justification:

primary effect is local effect

AF for interspecies differences (allometric scaling):

1

Justification:

primary effect is local effect

AF for other interspecies differences:

1

Justification:

mechanism destruction of membranes

AF for intraspecies differences:

3

Justification:

ecetoc factor, factor of 5 is considered high, because of nature of effect (local)

AF for the quality of the whole database:

1

Justification:

NOAEL based on a study with a structural analogue, but with similar mechanism of action

AF for remaining uncertainties:

1

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Value:

125 µg/cm²

Most sensitive endpoint:

skin irritation/corrosion

DNEL related information

DNEL derivation method:

other: based on primary irritation test in maximisation study (CIT, 1994)

Overall assessment factor (AF):

10

Dose descriptor starting point:

other: non-irritant concentration of 1%

AF for dose response relationship:

2

Justification:

no complete report on irritation; differences between two studies

AF for interspecies differences (allometric scaling):

1

Justification:

primary effect is local effect

AF for other interspecies differences:

1

Justification:

mechanism destruction of membranes

AF for intraspecies differences:

5

Justification:

factor for workers considered worst case as no species difference was seen in dermal studies with rats and mice

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

high hazard (no threshold derived)

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:

no hazard identified

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

No DNELs were calculated for the general population as the test substance will be used only in industrial settings.