Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 toxicity studies by dermal and oral route reported LD50>2000 mg/kg (bw), which is above the threshold for classification within the EU.

Plant Sterols are not irritating to skin or eyes, nor are they sensitising by skin contact in both animal and human studies.

No adverse effects were reported in repeated dose toxicity studies for phytosterol esters and beta-sitosterol, both of which are components of Plant Sterols.

In vitro and in vivo studies indicate that Plant Sterols are not genotoxic.

Reproductive and developmental studies in rats and mice with Plant Sterols, phytosterol esters and phytostanol esters did not indicate any adverse effects fertility or developmental effects.

Overall Plant Sterols are not classified as hazardous to human health for any of the stipulated toxicological endpoints under REACH.

On the basis of the toxicological results for Plant Sterols, and the lack of adverse effects in any of the numerous studies that have conducted for the different endpoints, the quantification of DNELs (derived no effect levels) is not appropriate.

In addition for endpoints which traditionally cannot have a DNEL derived, such as irritation and sensitisation, there is no need for risk characterisation to be conducted as no adverse effect in terms of irritation or corrosion were identified in the respective studies.

Therefore, as the quantification of a DNEL is not required for Plant Sterols, it is not necessary to quantify the exposure by modelling for human health.

In terms of risk management measures, it would however be prudent to recommend the precautionary use of gloves and safety glasses and to highlight the necessity to ensure good general hygiene measures are adhered to in the workplace.

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 toxicity studies by dermal and oral route reported LD50>2000 mg/kg (bw), which is above the threshold for classification within the EU.

Plant Sterols are not irritating to skin or eyes, nor are they sensitising by skin contact in both animal and human studies.

No adverse effects were reported in repeated dose toxicity studies for phytosterol esters and beta-sitosterol, both of which are components of Plant Sterols.

In vitro and in vivo studies indicate that Plant Sterols are not genotoxic.

Reproductive and developmental studies in rats and mice with Plant Sterols, phytosterol esters and phytostanol esters did not indicate any adverse effects fertility or developmental effects.

Overall Plant Sterols are not classified as hazardous to human health for any of the stipulated toxicological endpoints under REACH.

On the basis of the toxicological results for Plant Sterols, and the lack of adverse effects in any of the numerous studies that have conducted for the different endpoints, the quantification of DNELs (derived no effect levels) is not appropriate.

In addition for endpoints which traditionally cannot have a DNEL derived, such as irritation and sensitisation, there is no need for risk characterisation to be conducted as no adverse effect in terms of irritation or corrosion were identified in the respective studies.

Therefore, as the quantification of a DNEL is not required for Plant Sterols, it is not necessary to quantify the exposure by modelling for human health.

In terms of risk management measures, it would however be prudent to recommend the precautionary use of gloves and safety glasses and to highlight the necessity to ensure good general hygiene measures are adhered to in the workplace.