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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:
49 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:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
4 900 mg/m³
Explanation for the modification of the dose descriptor starting point:

As written in the ECHA R8 guidance the NOAEL oral rat of 500 mg/kg/day has been multiplied by 70 kg bw (mean body weight of human) and divided by 10 m3/person (respiratory volume light activity for workers) in order to calculate the NAEC worker (8h). Furthermore a correction was done for the difference between worker and experimental exposure conditions (1.4)

NAEC worker (8h) = 3500 mg/m3 * 1.4 = 4900 mg/m3

Since the particle size is high: D50= 150.4 µm (sieving + laser granulometry), smaller particles are in the range 30 to 50 µm, and there are no particles < 10 µm (respirable fraction) the absorption by inhalation is considered to be low. Therefore for the calculation of the DNEL it was assumed that oral and inhalation absorptions are similar and no additional factor was used for the modification of the dose descriptor.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
ECHA R8 default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA R8 default assessment factor for rats.
AF for other interspecies differences:
2.5
Justification:
ECHA R8 default assesment factor.
AF for intraspecies differences:
5
Justification:
ECHA R8 default assesment factor.
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
98 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

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:
7 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
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In the OECD 421 study selected for the derivation of the DNEL, treatment was administered to rats 7 days per week. Workers are exposed only during working days: 5 days per weeks. Therefore a factor of 1.4 (5/7 days) was used to modify the dose descriptor based on the difference of exposure between animals and workers.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
ECHA R8 default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA R8 default assessment factor for rats.
AF for other interspecies differences:
2.5
Justification:
ECHA R8 default assessment factor.
AF for intraspecies differences:
5
Justification:
ECHA R8 default assessment factor.
AF for the quality of the whole database:
1
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low 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:
8.75 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):
200
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Value:
1 750 mg/m³
Explanation for the modification of the dose descriptor starting point:

As written in the ECHA R8 guidance the NOAEL oral rat has been multiplied by 70 kg bw (mean body weight of human) and divided by 20 m3/person (respiratory volume for general population during 24h) in order to calculate the NAEC human (24h). No correction is required for the differences between human and experimental exposure conditions.

NAEC general population (24h) = 1750 mg/m3

Since the particle size is high: D50= 150.4 µm (sieving + laser granulometry), smaller particles are in the range 30 to 50 µm, and there are no particles < 10 µm (respirable fraction) the absorption by inhalation is considered to be low. Therefore for the calculation of the DNEL it was assumed that oral and inhalation absorptions are similar and no additional factor was used for the modification of the dose descriptor.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
ECHA R8 guidance default assessment factor for subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA R8 guidance default assessment factor for rats.
AF for other interspecies differences:
2.5
Justification:
ECHA R8 guidance default assessment factor.
AF for intraspecies differences:
10
Justification:
ECHA R8 guidance default assessment factor.
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

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:
2.5 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
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification was done.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
ECHA R8 guidance default assessment factor for subchronic to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA R8 guidance default assessment factor for rats.
AF for other interspecies differences:
2.5
Justification:
ECHA R8 guidance default assessment factor.
AF for intraspecies differences:
10
Justification:
ECHA R8 guidance default assessment factor.
AF for the quality of the whole database:
1
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:
DNEL (Derived No Effect Level)
Value:
2.5 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
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification was done.

AF for dose response relationship:
1
Justification:
ECHA R8 guidance default assessment factor.
AF for differences in duration of exposure:
2
Justification:
ECHA R8 guidance default assessment factor (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA R8 guidance default assessment factor for rats.
AF for other interspecies differences:
2.5
Justification:
ECHA R8 guidance default assessment factor.
AF for intraspecies differences:
10
Justification:
ECHA R8 guidance default assessment factor.
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Ethylvanillin is classified irritating for eyes and can induce irritation of the respiratory tract.

General population would not be exposed directly to pure and particle form of ethylvanillin, but by different cosmetic, food products . . . (diluted products).

By this way, the eye and respiratory tract irritant hazard would be reduced, and no specific recommendation to protect general population against these two effects would be proposed.

For the chemical risk assessment, no qualitative approach would be done for the general population, only a quantitative risk assessment was done.