Registration Dossier
Registration Dossier
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EC number: 232-504-3 | CAS number: 8060-28-4
Toxicological Summary
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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