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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified

Additional information - workers

Acute / short-term DNELs - systemic and local effects - have not been derived because Sucroglyceride C12-18, C18unsatd. does not meet the criteria to be classified dangerous for acute toxicity. Furthermore, Sucroglyceride C12-18, C18unsatd. is not classified dangerous for skin/eye irritation/corrosion, skin sensitisation, respiratory irritation/corrosion and respiratory sensitisation.

 

Long-term DNELs – local effects - have not been derived because Sucroglyceride C12-18, C18unsatd. does not meet the criteria to be classified dangerous for skin/eye irritation/corrosion, skin sensitisation, respiratory irritation/corrosion and respiratory sensitisation.

 

Long-term DNELs – systemic effects:

The properties of Sucroglyceride C12-18, C18unsatd. for repeated dose toxicity have been examined in read-across studies performed on a structural analogue (subacute oral repeated dose toxicity) and on a source substance and constituent (subchronic oral repeated dose toxicity).

Since up to and including the limit dose of 1000 mg/kg bw/day, the animals were free of any critical substance related effects, it can be assumed that Sucroglyceride C12-18, C18unsatd. has no intrinsic hazardous toxic activity relevant to humans by single oral or dermal exposure and by repeated oral exposure.

Because of this proven absence of intrinsic hazardous activity, Sucroglyceride C12-18, C18unsatd. poses no risk relevant to humans by repeated dermal exposure and a calculation of a corresponding Derived No Effect Level (DNEL) is not appropriate as no NOAEL based on toxic effects could be determined in adequately conducted studies.

In the oral repeated dose toxicity studies the NOAEL is >= 1000 mg/kg bw/day for male and female rats. A point of departure for the assessment of systemic toxicity after oral and dermal exposure could not be derived due to the lack of substance related critical health effects up to and including the limit dose of the studies design.

As an actual value for the NOAEL could not be determined due to limit dose testing in these study types, it could be much higher than 1000 mg/kg bw/day. Sucroglyceride C12-18, C18unsatd. has a limited potential of being dermally absorbed. Its unreacted constituents are either small molecules like sucrose and glycerol which may be absorbed or they are naturally occurring C12-C18 fatty acids which are unlikely to penetrate the skin. In either case, the characteristics of the constituents are such that intrinsic hazard can be excluded. Fatty acid esters of glycerol or sucrose, on the other hand, are likely to be degraded rapidly into the building blocks and then further metabolised, again under exclusion of intrinsic hazard. 

 

Based on the high mean molecular weight (> 500) and on the log Pow values > 4 for major part of the reaction products and constituents if Sucroglyceride C12-18, C18unsatd., a default value of 10% dermal absorption is proposed for risk assessment purposes.

 

Based on the 90-day oral repeated-dose study, the derivation of a Consumer DNEL long-term oral is not indicated due to the lack of an appropriate point of departure (NOAEL >= 1000 mg/kg bw/d). For risk assessment purposes the oral absorption of Sucroglyceride C12-18, C18unsatd. is set at 100%, considering a overall complete absorption either of the constituents or of the reaction products or of their degradation products, respectively. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.

 

Inhalation studies are not available. Sucroglyceride C12-18, C18unsatd. is a waxy solid paste, hence the generation of inhalable particles such as dust or aerosols is not significant. Furthermore, and even though the measurement of the vapour pressure is technically not feasible, it is expected to be low and vapourisation is not likely to occur. Although it is unlikely that Sucroglyceride C12-18, C18unsatd. will be absorbed to a high extent after inhalation via the lungs, for risk assessment purposes the inhalation absorption of Sucroglyceride C12-18, C18unsatd. is set at 10% as a worst case assumption.

Formation of vapours or inhalable aerosols, particles or droplets at the working place can be excluded. Therefore, a DNEL for inhalative exposure appears not warranted.

 

A DNEL for fertility and developmental toxicity has not been derived because in the prenatal developmental toxicity study and in the 90 day repeated dose toxicity study there have been no substance related adverse effects up to and including the limit dose of 1000 mg/kg bw/d. Thus it can be assumed that Sucroglyceride C12-18, C18unsatd. has no intrinsic toxic activity relevant to fertility or developmental toxicity by single or repeated oral or dermal exposure.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Acute / short-term DNELs - systemic and local effects - have not been derived because Sucroglyceride C12-18, C18unsatd. does not meet the criteria to be classified dangerous for acute toxicity. Furthermore, Sucroglyceride C12 -18, C18unsatd. is not classified dangerous for skin/eye irritation/corrosion, skin sensitisation, respiratory irritation/corrosion and respiratory sensitisation.

 

Long-term DNELs – local effects - have not been derived because Sucroglyceride C12 -18, C18unsatd. does not meet the criteria to be classified dangerous for skin/eye irritation/corrosion, skin sensitisation, respiratory irritation/corrosion and respiratory sensitisation.

 

Long-term DNELs – systemic effects:

The properties of Sucroglyceride C12-18, C18unsatd. for repeated dose toxicity have been examined in read-across studies performed on a structural analogue (subacute oral repeated dose toxicity) and on a source substance and constituent (subchronic oral repeated dose toxicity).

Since up to and including the limit dose of 1000 mg/kg bw/day, the animals were free of any critical substance related effects, it can be assumed that Sucroglyceride C12-18, C18unsatd. has no intrinsic hazardous toxic activity relevant to humans by single oral or dermal exposure and by repeated oral exposure.

Because of this proven absence of intrinsic hazardous activity, Sucroglyceride C12 -18, C18unsatd. poses no risk relevant to humans by repeated dermal exposure and a calculation of a corresponding Derived No Effect Level (DNEL) is not appropriate as no NOAEL based on toxic effects could be determined in adequately conducted studies.

In the oral repeated dose toxicity studies the NOAEL is >= 1000 mg/kg bw/day for male and female rats. A point of departure for the assessment of systemic toxicity after oral and dermal exposure could not be derived due to the lack of substance related critical health effects up to and including the limit dose of the studies design.

As an actual value for the NOAEL could not be determined due to limit dose testing in these study types, it could be much higher than 1000 mg/kg bw/day. Sucroglyceride C12 -18, C18unsatd. has a limited potential of being dermally absorbed. Its unreacted constituents are either small molecules like sucrose and glycerol which may be absorbed or they are naturally occurring C12-C18 fatty acids which are unlikely to penetrate the skin. In either case, the characteristics of the constituents are such that intrinsic hazard can be excluded. Fatty acid esters of glycerol or sucrose, on the other hand, are likely to be degraded rapidly into the building blocks and then further metabolised, again under exclusion of intrinsic hazard. 

 

Based on the high mean molecular weight (> 500) and on the log Pow values > 4 for major part of the reaction products and constituents if Sucroglyceride C12 -18, C18unsatd., a default value of 10% dermal absorption is proposed for risk assessment purposes.

 

Based on the 90-day oral repeated-dose study, the derivation of a Consumer DNEL long-term oral is not indicated due to the lack of an appropriate point of departure (NOAEL >= 1000 mg/kg bw/d). For risk assessment purposes the oral absorption of Sucroglyceride C12-18, C18unsatd. is set at 100%, considering a overall complete absorption either of the constituents or of the reaction products or of their degradation products, respectively. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.

 

Inhalation studies are not available. Sucroglyceride C12-18, C18unsatd. is a waxy solid paste, hence the generation of inhalable particles such as dust or aerosols is not significant. Furthermore, and even though the measurement of the vapour pressure is technically not feasible, it is expected to be low and vapourisation is not likely to occur.Although it is unlikely that Sucroglyceride C12-18, C18unsatd. will be absorbed to a high extent after inhalation via the lungs, for risk assessment purposes the inhalation absorption of Sucroglyceride C12-18, C18unsatd. is set at 10% as a worst case assumption.

Formation of vapours or inhalable aerosols, particles or droplets for the general population can be excluded. Therefore, a DNEL for inhalative exposure appears not warranted.

 

A DNEL for fertility and developmental toxicity has not been derived because in the prenatal developmental toxicity study and in the 90 day repeated dose toxicity study there have been no substance related adverse effects up to and including the limit dose of 1000 mg/kg bw/d. Thus it can be assumed that Sucroglyceride C12-18, C18unsatd. has no intrinsic toxic activity relevant to fertility or developmental toxicity by single or repeated oral or dermal exposure.