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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20.36 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):
25
Modified dose descriptor starting point:
NOAEC
Value:
509 mg/m³
Explanation for the modification of the dose descriptor starting point:
8 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation, no inhalation study available. Corrected inhalatory NOAEC = 578 mg/kg bw/day*(1/0.38 m3/kg/day)*(50%/100%)*(6.7 m3 (8h)/10 m3 (8h)) = 509 mg/m³
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not for concentrations
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
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:
5.78 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
578 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
assumed that rat oral and dermal absorptions are equal to human oral and dermal absorption
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor rat-human
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The long-term inhalation DNEL for systemic effects is derived from the subchronic oral: feeding toxicity study (17-week study) with read across substance acetophenone, where the NOAEL is 518 mg/kg bw/day for acetophenone corresponding to 578 mg/kg bw/day for 4’-methylacetophenone. Route-to-route (oral to inhalation) extrapolation was performed. The calculated DNEL is 20.36 mg/m³, applying the assessment factor of 25.

The acute/short term inhalation DNEL for systemic was not required, since the substance is unlikely to exhibit significant acute inhalation toxicity and exert significant local effects on respiratory mucosal membranes. The inhalation long- and acute/short term DNELs for local effects was not assessed, since a low hazard was identified for 4’-methylacetophenone, based on skin irritation properties of the compound.

The long-term dermal DNEL for systemic effects is derived from the subchronic oral feeding toxicity study (17-week study). For the route-to-route extrapolation it was assumed that oral and dermal absorption in the rat are equal to human oral and dermal absorption. The calculated DNEL is 5.78 mg/kg bw/day, applying the assessment factor of 100.

The acute/short term exposure dermal DNEL for systemic effects was not assessed, since no hazard was identified for 4'-methylacetophenone acute dermal toxicity, LD50 > 2000 mg/kg bw.

The long- and acute/short term dermal DNELs for local effects was not assessed, since a low hazard was identified for 4’-methylacetophenone. The highest non-skin irritating concentration in the sensitisation study with guinea pigs was 20% and workers handling the neat substance or fragrance compounds containing high concentrations of the substance must use appropriate dermal protection to avoid contact.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.03 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
Modified dose descriptor starting point:
NOAEC
Value:
251 mg/m³
Explanation for the modification of the dose descriptor starting point:
24 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation, no inhalation study available. Corrected inhalatory NOAEC = 578 mg/kg bw/day*(1/1.15 m3/kg/day)*(50%/100%) = 251 mg/m3
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not for concentration
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.89 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
578 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
assumed that rat oral and dermal absorptions are equal to human oral and dermal absorption
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor rat-human
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.89 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
578 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route-to-route extrapolation performed
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor rat-human
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
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:
no hazard identified

Additional information - General Population

The long-term inhalation DNEL for systemic effects is derived from the subchronic oral: feeding toxicity study (17-week study) with read across substance acetophenone, where the NOAEL is 518 mg/kg bw/day for acetophenone and 578 mg/kg bw/day for 4’-methylacetophenone. Route-to-route (oral to inhalation) extrapolation was performed. The calculated DNEL is 5.03 mg/m³, applying the assessment factor of 50.

The acute/short term inhalation DNEL for systemic effects was not required, since the substance is unlikely to exhibit significant acute inhalation toxicity and exert significant local effects on respiratory mucosal membranes.

The inhalation long- and acute/short term DNELs for local effects was not assessed, since a low hazard was identified for 4’-methylacetophenone, based on skin irritation properties of the compound.

The long-term dermal DNEL for systemic effects is derived also from the subchronic oral: feeding toxicity study (17-week study). For the route-to-route (oral-dermal) extrapolation it was assumed that oral and dermal absorption in the rat are equal to human oral and dermal absorption. The calculated DNEL is 2.89 mg/kg bw/day, applying the assessment factor of 200.

The acute/short term dermal DNEL for systemic effects was not assessed, since 4'-methylacetophenone shows a low acute dermal toxicity, LD50 > 2000 mg/kg bw.

The dermal long- and acute/short term DNELs for local effects were not assessed. Based on the available information a low hazard for local effects is assumed for the neat substance in accordance with ECHA guidance Part E. It should be considered that fragranced end-products meant for end-use by the general public contain low amounts of the substance, i.e. generally less than 1%. The concentration of the substance in fragranced end-products is clearly below the generic concentration limit triggering classification of a mixture as skin irritant (10% according to Table 3.2.3 of Regulation (EC) No 1272/2008). Therefore, no hazard for local effects is anticipated.

The long-term oral DNEL for systemic effects is derived from the subchronic oral: feeding toxicity study. No route-to-route extrapolation was performed. The calculated DNEL is 2.89 mg/kg bw/day, applying assessment factor of 200. This DNEL covers the acute/short term oral exposure as well.