Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70.53 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
DNEL value:
1 736.2 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/0.38 m³/kg/d)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 1000 mg/kg/d*(1/0.38 m³/kg/d)*(1/1)*0.67 = 1763.2 mg/m³
AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
The DNEL is based on a subchronic study
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling already included in ECHA starting point derivation method; no further factor required.
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 000 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
DNEL value:
10 000 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = oral NOAEL*(ABSoral-rat/ABSdermal-human) = (1000 mg/kg bw/day)*(1/0.0001) = 10000000 mg/kg bw/day.
AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
The DNEL is based on a subchronic study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on a study in rat
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Inhalation DNEL worker

The calculation of the inhalation DNEL was based on route-to-route extrapolation from the subchronic (90-day) oral NOAEL of 1000 mg/kg bw/day in rats derived for D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9).

 

Dermal DNEL worker

The calculation of the dermal DNEL was based on the subchronic (90-day) oral NOAEL of 1000 mg/kg bw/day in rats for D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9).

Based on molecular weight, log Pow, water solubility and dermal absorption data for D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1), dermal absorption of D-Glucopyranose, oligomeric, undecyl glycoside was judged to be negligible (0.01% refer to section 7.1 dermal absorption). Therefore, the NOAELcorr-dermal was considered to be 10000000 mg/kg bw/day derived by route-to-route extrapolation from the oral NOAEL of 1000 mg/kg bw/day.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.4 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
DNEL value:
869.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/1.15 m³/kg/d)*(ABSoral-rat/ABSinh-human) = 1000 mg/kg/d*(1/1.15 m³/kg/d)*(1/1) = 869.6 mg/m³
AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
The DNEL is based on a subchronic study
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling already included in ECHA starting point derivation method; no further factor required.
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 000 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
DNEL value:
10 000 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = oral NOAEL*(ABSoral-rat/ABSdermal-human) = (1000 mg/kg bw/day)*(1/0.0001) = 10000000 mg/kg bw/day.
AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
The DNEL is based on a subchronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rat
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No modification of dose descriptor starting point required.
AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
The DNEL is based on a subchronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rat
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute 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

Inhalation DNEL consumer

The calculation of the inhalation DNEL was based on route-to-route extrapolation from the subchronic (90-day) oral NOAEL of 1000 mg/kg bw/day in rats derived for D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9).

 

Dermal DNEL consumer

The calculation of the dermal DNEL was based on the subchronic (90-day) oral NOAEL of 1000 mg/kg bw/day in rats for D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9).

Based on molecular weight, log Pow, water solubility and dermal absorption data for D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1), dermal absorption of D-Glucopyranose, oligomeric, undecyl glycoside was judged to be negligible (0.01% refer to section 7.1 dermal absorption). Therefore, the NOAELcorr-dermal was considered to be 10000000 mg/kg bw/day derived by route-to-route extrapolation from the oral NOAEL of 1000 mg/kg bw/day.

 

Oral DNEL consumer

The calculation of the oral DNEL was based on the subchronic (90-day) oral NOAEL of 1000 mg/kg bw/day in rats for D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9).