Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
180
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The dermal DNEL for long-term exposure of workers is based on the most critical NOAEL of 1500 mg/kg bw/day, which was identified in the dermal 21-day repeated dose toxicity study in rabbits.

Applied assessment factors are for allometric scaling (2.4, rabbit to human), remaining interspecies differences (2.5, default value), exposure duration (6, subacute to chronic), and intraspecies differences (5, workers), according to the Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.

An inhalation DNEL was not derived as no exposure by inhalation is expected based on the low vapour pressure of ethylhexyl methoxycinnamate (0.3 hPa). As no acute toxicity hazard is identified for ethylhexyl methoxycinnamate (no classification and labelling needed), and no high peak exposures are expected, no acute DNELs were derived.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.17 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
360
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The oral DNEL for long-term exposure of the general population is based on the most critical NOAEL of 450 mg/kg bw/day, which was identified in the oral 90-day repeated dose toxicity study in rats. The dermal DNEL for long-term exposure of the general population is based on the most critical NOAEL of 1500 mg/kg bw/day, which was identified in the dermal 21-day repeated dose toxicity study in rabbits.

Applied assessment factors for derivation of the oral DNEL are for allometric scaling (4, rat to human), remaining interspecies differences (2.5, default value), exposure duration (2, subchronic to chronic), and intraspecies differences (10, general population).
Applied assessment factors for derivation of the dermal DNEL are for allometric scaling (2.4, rabbit to human), remaining interspecies differences (2.5, default value), exposure duration (6, subacute to chronic), and intraspecies differences (10, general population). Assessment factors were applied according to the Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.

An inhalation DNEL was not derived as no exposure by inhalation is expected based on the low vapour pressure of ethylhexyl methoxycinnamate (0.3 hPa). As no acute toxicity hazard is identified for ethylhexyl methoxycinnamate (no classification and labelling needed), and no high peak exposures are expected, no acute DNELs were derived.