Registration Dossier

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

The ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health states as follows:

 

REACH requires a risk characterisation for the leading health effect (i.e., the toxicological effect that results in the most critical Derived No Effect Level (DNEL) for a given exposure pattern (duration, frequency, route and exposed human population) associated with an exposure scenario (ES). 

 

In the event of no health effects being noted, no risk characterisation is required, as derivation of threshold values for “no effects” is not viable.

 

The substance subject to the registration demonstrates no hazardous effects with the exception of it being a potential aspiration hazard due to its viscosity. This is a physical hazard, and extrapolation of DNEL for this value is not applicable.

 

The substance is not harmful by oral or dermal exposure. There is no evidence that as a mineral oil, the substance would be significantly absorbed via the oral, dermal or inhalation routes. The results of oral acute toxicity study data along with significant evidence from the literature indicate that it is unlikely to be absorbed orally. In addition, there is sufficient evidence to indicate that significant absorption through the dermis would not occur. There is negligible information on inhalation exposure effects; however the intrinsic properties indicate that exposure to vapours would not occur. Sufficient practical risk management measures are in place to avoid exposure to aerosols of the substance, and hence exposure via inhalation is predicted not to occur. A acute toxicity inhalation study was conducted nevertheless using wistar strain rats which demonstrated there were no significant effects associated with the substance.

 

 

The substance is not a skin irritant or skin sensitiser, and has negligible irritancy to the eye. Whilst no data is available for the potential to cause respiratory sensitisation, historical use of white oils suggests that these materials are not respiratory irritants; the vapour pressure is not sufficiently high enough to cause effects. No effects are predicted.

 

In repeat dose studies on white mineral oils, species specific effects are noted. It is proposed that classification and labelling is not considered attributable to these effects.  The effects noted appear to be specific to the Fischer strain and this is adequately proven. In reproduction toxicity studies, Reproduction and fertility was unaffected by treatment. No test-material-related microscopic changes were observed in the testes or epididymides of adult male rats or in the ovaries of adult female rats.

 

Genetic toxicity is assessed using a combination of available study data and information on analogous oils. Base oils of this type are proposed to not induce mutagenicity in mammalian cells.  This is endorsed by the negative results obtained in Ames test, chromosome aberration, mammalian cell gene mutation assay and mammalian somatic cell study conducted on the substance, which clearly shows no effects in addition to suitable literature information

Carcinogenicity is not associated with this substance. A published literature paper based on a analogous substance reported that tumours in rats were observed in all dose groups (including the control groups), however the neoplastic lesions were histologically similar to those known to occur spontaneously in F344 rats and as such is deemed to be a species dependent effect and not relevant to humans.

Commercially available white oils are quantified based on their physico-chemical properties; namely boiling point and associated viscosity. In accordance with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, the following classification is appropriate.

 

H304: May be fatal if swallowed and enters airways

 

It is considered that providing the risk of aspiration hazard is controlled by appropriate handling, the material is considered as safe for use in all applications. No specific assessment of DNEL for workers or consumers is therefore required.

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

The ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health states as follows:

 

REACH requires a risk characterisation for the leading health effect (i.e., the toxicological effect that results in the most critical Derived No Effect Level (DNEL) for a given exposure pattern (duration, frequency, route and exposed human population) associated with an exposure scenario (ES). 

 

In the event of no health effects being noted, no risk characterisation is required, as derivation of threshold values for “no effects” is not viable.

 

The substance subject to the registration demonstrates no hazardous effects with the exception of it being a potential aspiration hazard due to its viscosity. This is a physical hazard, and extrapolation of DNEL for this value is not applicable.

 

The substance is not harmful by oral or dermal exposure. There is no evidence that as a mineral oil, the substance would be significantly absorbed via the oral, dermal or inhalation routes. The results of oral acute toxicity study data along with significant evidence from the literature indicate that it is unlikely to be absorbed orally. In addition, there is sufficient evidence to indicate that significant absorption through the dermis would not occur. There is negligible information on inhalation exposure effects; however the intrinsic properties indicate that exposure to vapours would not occur. Sufficient practical risk management measures are in place to avoid exposure to aerosols of the substance, and hence exposure via inhalation is predicted not to occur. A acute toxicity inhalation study was conducted nevertheless using wistar strain rats which demonstrated there were no significant effects associated with the substance.

 

The substance is not a skin irritant or skin sensitiser, and has negligible irritancy to the eye. Whilst no data is available for the potential to cause respiratory sensitisation, historical use of white oils suggests that these materials are not respiratory irritants; the vapour pressure is not sufficiently high enough to cause effects. No effects are predicted.

 

In repeat dose studies on white mineral oils, species specific effects are noted. It is proposed that classification and labelling is not considered attributable to these effects.  The effects noted appear to be specific to the Fischer strain and this is adequately proven. In reproduction toxicity studies, Reproduction and fertility was unaffected by treatment. No test-material-related microscopic changes were observed in the testes or epididymides of adult male rats or in the ovaries of adult female rats.

 

Genetic toxicity is assessed using a combination of available study data and information on analogous oils. Base oils of this type are proposed to not induce mutagenicity in mammalian cells.  This is endorsed by the negative results obtained in Ames test, chromosome aberration, mammalian cell gene mutation assay and mammalian somatic cell study conducted on the substance, which clearly shows no effects in addition to suitable literature information.

Carcinogenicity is not associated with this substance. A published literature paper based on a analogous substance reported that tumours in rats were observed in all dose groups (including the control groups), however the neoplastic lesions were histologically similar to those known to occur spontaneously in F344 rats and as such is deemed to be a species dependent effect and not relevant to humans.

Commercially available white oils are quantified based on their physico-chemical properties; namely boiling point and associated viscosity. In accordance with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, the following classification is appropriate.

 

H304: May be fatal if swallowed and enters airways

 

It is considered that providing the risk of aspiration hazard is controlled by appropriate handling, the material is considered as safe for use in all applications. No specific assessment of DNEL for workers or consumers is therefore required.