Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.33 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:
other: NOEC
Value:
183.37 mg/m³
Explanation for the modification of the dose descriptor starting point:
Allometric scaling is applied as described in ECHA technical guidance the oral NOEL in the rat mg/kg/day *1/0.38 * 6.7/10 = mg/m3 inhalation NOEC for workers.
AF for dose response relationship:
1
Justification:
The default assessment factor for NOEL is 1.
AF for differences in duration of exposure:
2
Justification:
ECHA guidance indicates a factor of 2 for extrapolation from subchronic to chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
5
Justification:
ECHA guidance indicates a default assessment factor of 5 for workers.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.33 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Explanation for the modification of the dose descriptor starting point:
Allometric scaling is applied as described in ECHA technical guidance the oral NOEL in the rat mg/kg/day *1/0.38 * 6.7/10 = mg/m3 inhalation NOEC for workers.

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.04 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:
other: NOEL
Value:
104 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.
AF for dose response relationship:
1
Justification:
The default assessment factor for NOEL is 1.
AF for differences in duration of exposure:
2
Justification:
ECHA guidance indicates a factor of 2 for extrapolation from subchronic to chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scalling factor for rat to human is 4.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
5
Justification:
ECHA guidance indicates a default assessment factor of 5 for workers.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.04 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Explanation for the modification of the dose descriptor starting point:
No default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.

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:
low hazard (no threshold derived)

Additional information - workers

As basis for DNEL derivation the result from a 90-days study was used. The study was carried out on an analogue substance polyoxyethylene (1-6) alkylamine (C12-C22) fatty acid (C12-C22) ester as read-across information. The max. Safety level (NOEL) of the substance was 0.1% in diet and the corresponding dose value for male rats was 104.0 mg/kg/day obtained from their average food consumption.

Allometric scaling is applied as described in ECHA technical guidance the oral NOEL in the rat mg/kg/day *1/0.38 * 6.7/10 = mg/m3 inhalation NOEC for workers.

The NOELcorr for dermal therefore remains unchanged.

The local effects and hazard for eyes are with low hazard (no threshold derived) due to the lack of relevant response observed in available studies.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.81 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:
other: NOEL
Value:
90.43 mg/m³
Explanation for the modification of the dose descriptor starting point:
Allometric scaling is applied as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/1.15 = mg/m3 inhalation NOAEC for general population.
AF for dose response relationship:
1
Justification:
The default assessment factor for NOEL is 1.
AF for differences in duration of exposure:
2
Justification:
ECHA guidance indicates a factor of 2 for extrapolation from subchronic to chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
10
Justification:
ECHA guidance indicates a default assessment factor of 10 for general population.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.81 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Explanation for the modification of the dose descriptor starting point:
Allometric scaling is applied as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/1.15 = mg/m3 inhalation NOAEC for general population.

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.52 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:
other: NOEL
Value:
104 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.
AF for dose response relationship:
1
Justification:
The default assessment factor for NOEL is 1.
AF for differences in duration of exposure:
2
Justification:
ECHA guidance indicates a factor of 2 for extrapolation from subchronic to chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scalling factor for rat to human is 4.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
10
Justification:
ECHA guidance indicates a default assessment factor of 10 for general population.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.52 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Explanation for the modification of the dose descriptor starting point:
No default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.52 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:
other: NOEL
Value:
104 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation is applied.
AF for dose response relationship:
1
Justification:
The default assessment factor for NOEL is 1.
AF for differences in duration of exposure:
2
Justification:
ECHA guidance indicates a factor of 2 for extrapolation from subchronic to chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scalling factor for rat to human is 4.
AF for other interspecies differences:
2.5
Justification:
No substance specific data is available.
AF for intraspecies differences:
10
Justification:
ECHA guidance indicates a default assessment factor of 10 for general population.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.52 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

As basis for DNEL derivation the result from a 90-days study was used. The study was carried out on an analogue substance polyoxyethylene (1-6) alkylamine (C12-C22) fatty acid (C12-C22) ester as read-across information. The max. Safety level (NOEL) of the substance was 0.1% in diet and the corresponding dose value for male rats was 104.0 mg/kg/day obtained from their average food consumption.

Allometric scaling is applied as described in ECHA technical guidance the oral NOEL in the rat mg/kg/day *1/1.15 = mg/m3 inhalation NOEC for general population.

The NOELcorr for dermal therefore remains unchanged.

The local effects and hazard for eyes are with low hazard (no threshold derived) due to the lack of relevant response observed in available studies.