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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A number of historical toxicity studies have been referenced; the starting point is from a 90 day oral rat NOAEL, but other sub-chronic studies have higher NOAEL improving the degree of certainty that this is indeed a suitable starting point. Adverse effects were mainly due to low weight gain and poor general health, thought to be due to taste aversion. The true NOAEL is likely to be considerably higher than the 150 mg/kg/day used in this estimate.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
The substance rapidly metabolises (half-life < 1 hour) so no accumulative effects need to be taken into account.
The absence of systemic toxic effects indicates acute effects only.
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Justification:
A range of studies are available and a conservative NOAEL used for starting.
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)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 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):
25
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A number of historical toxicity studies have been referenced; the starting point is from a 90 day oral rat NOAEL, but other sub-chronic studies have higher NOAEL improving the degree of certainty that this is indeed a suitable starting point. Adverse effects were mainly due to low weight gain and poor general health, thought to be due to taste aversion. The true NOAEL is likely to be considerably higher than the 150 mg/kg/day used in this estimate.

There is no evidence of dermal absorption.

AF for dose response relationship:
0.5
Justification:
There is no evidence of direct absorption, but essential oils used in cosmetics show a typical 50% dermal penetration
AF for differences in duration of exposure:
1
Justification:
The substance rapidly metabolises (half-life < 1 hour) so no accumulative effects need to be taken into account.
The absence of systemic toxic effects indicates acute effects only.
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Justification:
A range of studies are available and a conservative NOAEL used for starting.
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:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
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:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A number of historical toxicity studies have been referenced; the starting point is from a 90 day oral rat NOAEL, but other sub-chronic studies have higher NOAEL improving the degree of certainty that this is indeed a suitable starting point. Adverse effects were mainly due to low weight gain and poor general health, thought to be due to taste aversion. The true NOAEL is likely to be considerably higher than the 150 mg/kg/day used in this estimate.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
The substance rapidly metabolises (half-life < 1 hour) so no accumulative effects need to be taken into account.
The absence of systemic toxic effects indicates acute effects only.
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
A range of studies are available and a conservative NOAEL used for starting.
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)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 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):
50
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
AF for dose response relationship:
0.5
Justification:
Dermal DNEL is mitigated by applying a reduction factor of 0.5 to reflect dermal penetration of < 50% of material applied to skin; this is in line with poorly water soluble 'essential' oils used in cosmetics and therapies.
AF for differences in duration of exposure:
1
Justification:
The substance rapidly metabolises (half-life < 1 hour) so no accumulative effects need to be taken into account.
The absence of systemic toxic effects indicates acute effects only.
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
Justification:
A range of studies are available and a conservative NOAEL used for starting.
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)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Hop opils are used extensively in foods and have been considered GRAS by US FDA with no limits on use.

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