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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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