Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.5 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):
37.5
Modified dose descriptor starting point:
NOAEC
DNEL value:
881.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation repeated toxicity study has been performed, because toxicological literature regarding alkyl polyglucosides is very exhaustive and no additional animal testing was deemed necessary.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation was a NOAEL, therfore the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
3
Justification:
An assessment factor of 3 has been applied in order to consider the differences the duration of the exposure in the oral 90-day repeated toxicity study and the
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling does not apply in case of oral-inhalation route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
No substance-specific data are available, so a default assessment factor of 2.5 has been applied for other interspecies differences.
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 has been chosen to cover workers, as this population does not cover the very young, the very old, and the very ill.
AF for the quality of the whole database:
1
Justification:
Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps.
AF for remaining uncertainties:
1
Justification:
No remaining uncertaintens are foreseen.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Modified dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation was necessary, because a 14-day repeated toxicity study was available for the dermal route of exposure.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation was a NOAEL, therfore the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
6
Justification:
Data derive from a subacute toxicity study.
AF for interspecies differences (allometric scaling):
2.4
Justification:
Allometric scaling for rabbits involves a default assessment factor of 2.4.
AF for other interspecies differences:
2.5
Justification:
No substance-specific data are available, so a default assessment factor of 2.5 has been applied for other interspecies differences.
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 has been chosen to cover workers, as this population does not cover the very young, the very old, and the very ill.
AF for the quality of the whole database:
1
Justification:
Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps. Moreover, the original study, although not available, is reported by a reliable source (Hill at al., 1997).
AF for remaining uncertainties:
1
Justification:
No remaining uncertaintens are foreseen.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
59 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor:
other: LOAEL: 60 mg/kg bw/day
AF for dose response relationship:
4
Justification:
The use of a LOAEL instead of a NOAEL involves the use of a default assessment factor between 3 and 10. In this case, the study does not report information on dose-response relationship.
AF for differences in duration of exposure:
1
Justification:
It has been considered that increasing the duration of exposure does not increase the severity of the irritative effects.
AF for interspecies differences (allometric scaling):
1
Justification:
No inter-species AF has been applied, because the mechanism of skin irritation is considered to be the same in experimental animals and in human.
AF for other interspecies differences:
1
Justification:
No inter-species AF has been applied, because the mechanism of skin irritation is considered to be the same in experimental animals and in human.
AF for intraspecies differences:
5
Justification:
An assessment factor of 5 has been chosen to cover workers, as this population does not cover the very young, the very old, and the very ill.
AF for the quality of the whole database:
1
Justification:
Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps. Moreover, the original study, although not available, is reported by a reliable source (CIR, 2011).
AF for remaining uncertainties:
1
Justification:
No remaining uncertaintens are foreseen.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Two DNEL values were derived for systemic effects after long-term exposure in workers: a dermal DNEL and an inhalation DNEL. Values were obtained from the NOAELs of an oral repeated toxicity study and of a NOAEL of a dermal 14-day repeated toxicity study. As this NOAELs were observed in an oral and a dermal study, respectively, a route-to-route extrapolation was needed in order to obtain the correct starting point for the derivation of the inhalation DNEL. Moreover, a DNEL for dermal local effects after repeated exposure was derived. In this case the dermal NAEL for local effects needed to be corrected into the correct unit. The correct starting points were then divided by an overall assessment factor, which was a result of various consideration on uncertainties in inter-and intra-species variations, and on differences in the duration of exposure between test animals and humans. Moreover also the whole quality of the database was considered. No DNEL was derived for local inhalation effects after long term exposure, for which a qualitative assessment has been performed.

 

For acute effects, no DNEL was deemed necessary, because no acute toxicity hazards (leading to C&L) have been identified, with the only exception of the risk of serious eye damage, which was considered from a qualitative point of view. Peak exposure to "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite"is not expected, and therefore the long-term DNELs are considered conservative enough to protect also from acute exposure risks.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.8 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):
75
Modified dose descriptor starting point:
NOAEC
DNEL value:
434.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation repeated toxicity study has been performed, because toxicological literature regarding alkyl polyglucosides is very exhaustive and no additional animal testing was deemed necessary.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation was a NOAEL, therfore the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
3
Justification:
An assessment factor of 3 has been applied in order to consider the differences the duration of the exposure in the oral 90-day repeated toxicity study and the
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling does not apply in case of oral-inhalation route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
No substance-specific data are available, so a default assessment factor of 2.5 has been applied for other interspecies differences.
AF for intraspecies differences:
10
Justification:
An assessment factor of 10 has been chosen to cover general population, as this population includes also the very young, the very old, and the very ill.
AF for the quality of the whole database:
1
Justification:
Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps.
AF for remaining uncertainties:
1
Justification:
No remaining uncertaintens are foreseen.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
360
Modified dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation was a NOAEL, therefore the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
6
Justification:
No assessment factor is considered necessary when data derives from a reproductive/developmental toxicity study.
AF for interspecies differences (allometric scaling):
2.4
Justification:
Allometric scaling for rabbits involves a default assessment factor of 2.4.
AF for other interspecies differences:
1
Justification:
An additional AF for interspecies differences is considered not necessary, because allometric scaling will be conservative enough.
AF for intraspecies differences:
10
Justification:
Intraspecies AF for general population, according to ECHA guidelines.
AF for the quality of the whole database:
1
Justification:
The available data are sufficient to correctly derive the inhalation DNEL
AF for remaining uncertainties:
2.5
Justification:
An assessment factor of 2.5 has been chosen to consider the read-across from the similar substance adipic acid.
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor:
other: LOAEL
AF for dose response relationship:
4
Justification:
The use of a LOAEL instead of a NOAEL involves the use of a default assessment factor between 3 and 10. In this case, the study does not report information on dose-response relationship.
AF for differences in duration of exposure:
1
Justification:
It has been considered that increasing the duration of exposure does not increase the severity of the irritative effects.
AF for interspecies differences (allometric scaling):
1
Justification:
No inter-species AF has been applied, because the mechanism of skin irritation is considered to be the same in experimental animals and in human.
AF for other interspecies differences:
1
Justification:
No inter-species AF has been applied, because the mechanism of skin irritation is considered to be the same in experimental animals and in human.
AF for intraspecies differences:
10
Justification:
An assessment factor of 10 has been chosen to cover general population, according to ECHA guidelines.
AF for the quality of the whole database:
1
Justification:
Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps. Moreover, the original study, although not available, is reported by a reliable source (CIR, 2011).
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties are foreseen.
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 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):
300
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 route-to-route extrapolation was necessary as the route of the starting study was oral.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation was a NOAEL, therfore the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
3
Justification:
An assessment factor of 3 has been applied in order to consider the differences the duration of the exposure in the oral 90-day repeated toxicity study and the
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling for rats involves a default assessment factor of 4.
AF for other interspecies differences:
2.5
Justification:
No substance-specific data are available, so a default assessment factor of 2.5 has been applied for other interspecies differences.
AF for intraspecies differences:
10
Justification:
An assessment factor of 10 has been chosen to cover general population, as this population includes also the very young, the very old, and the very ill.
AF for the quality of the whole database:
1
Justification:
Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps.
AF for remaining uncertainties:
1
Justification:
No remaining uncertaintens are foreseen.
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

Three DNELs were derived for systemic effects after long-term exposure in workers: an inhalation DNEL, a dermal DNEL and a DNEL for oral effects. The inhalation DNEL was obtained from the NOAEL of an oral repeated toxicity study, therefore a route-to-route extrapolation was needed in order to obtain the correct starting point for the derivation of the DNEL.

A DNEL for local effects after dermal exposure was also derived. In this case, the LOAEL for skin effects derived from the dermal repeated toxicity study had to be corrected in right unit (mg/cm2 from mg/kg bw/day).

The correct starting points were divided by an overall assessment factor, which was a result of various consideration on uncertainties in inter-and intra-species variations, and on differences in the duration of exposure between test animals and humans. Moreover also the whole quality of the database was considered. No DNEL was derived for local inhalation effects after long term exposure, for which a qualitative assessment has been performed.