Captan

Toxicological Summary

Workers - 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:

DNEL (Derived No Effect Level)

Value:

0.012 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

50

Dose descriptor:

NOAEC

AF for dose response relationship:

1

Justification:

NOEL/NOAEL was taken as dose descriptor (guidance r8)

AF for differences in duration of exposure:

2

Justification:

90-days study on rat (Hext, P.M. 1989) was used (sub-chronic to chronic)

AF for interspecies differences (allometric scaling):

2

Justification:

For inhalation correction of duration (6 hours study exposure vs. 8 hours worker exposure) and respiratory correction for light work was applied

AF for other interspecies differences:

2.5

Justification:

default factor (guidance r8)

AF for intraspecies differences:

5

Justification:

default factor for workers (guidance r8)

AF for the quality of the whole database:

1

Justification:

complete and consistent data

AF for remaining uncertainties:

1

Justification:

5 days application per week, comparable to workers

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.024 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

25

DNEL extrapolated from long term DNEL

Dose descriptor starting point:

NOAEC

AF for dose response relationship:

1

Justification:

NOEL/NOAEL was taken as dose descriptor (guidance r8)

AF for interspecies differences (allometric scaling):

2

Justification:

for inhalation correction of duration (6 hours study exposure vs. 8 hours worker exposure) and respiratory correction for light work was applied

AF for other interspecies differences:

2.5

Justification:

default factor (guidance r8)

AF for intraspecies differences:

5

Justification:

default factor for workers (guidance r8)

AF for the quality of the whole database:

1

Justification:

complete and consistent data

AF for remaining uncertainties:

1

Justification:

5 days application per week, comparable to workers

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

high hazard (no threshold derived)

Additional information - workers

DNEL were derived for local effects on respiratory tract based on repeated dose study. Systemic effects lower than local effects were not found for inhalation path.

For dermal contact main focus should be local effects on skin caused by sensitizing properties of captan. As no threshold is derived from maximisation test, hazard should be assessed by a qualitative approach.

Remark: On theoretical basis by application of default factors from ECHA guidance DNEL for systemic effects resulting from dermal contact can be calculated on basis of sub-acute repeated dose toxicity. DNEL calculation was not performed to avoid misunderstandings for workers.

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:

DNEL (Derived No Effect Level)

Value:

0.06 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

10

Dose descriptor:

NOAEC

AF for dose response relationship:

1

Justification:

NOEL/NOAEL was taken as dose descriptor

AF for differences in duration of exposure:

2

Justification:

90-days study on rat (Hext, P.M. 1989) was used (sub-chronic to chronic)

AF for interspecies differences (allometric scaling):

0.2

Justification:

For inhalation correction of duration (6 hours study exposure vs. 1 hour general population exposure) and respiratory correction for light work was applied

AF for other interspecies differences:

2.5

Justification:

default factor (guidance r8)

AF for intraspecies differences:

10

Justification:

Worst case factor. In reality negligible exposure of general population expected.

AF for the quality of the whole database:

1

Justification:

complete and consistent data

AF for remaining uncertainties:

1

Justification:

Onyl worst case assumption. No further uncertainties expected.

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.12 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

5

DNEL extrapolated from long term DNEL

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

Oral contact not relevant for general population. Captan powder is only used for formulation.

Subsequent use is for production of technical rubber goods and tyres with rests of captan bound in the polymer matrix.

Contact of general public with captan in technical rubber goods and tyres is not expected.