Raffinates (Fischer-Tropsch), C10-25-branched

Endpoint summary

Description of key information

All reliable read-across studies on skin and eye irritation for "Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids" show no or slight irritation effects on rabbit skin and eyes.
Respiratory Irritation - No studies were located to indicate that Raffinates (Fischer-Tropsch), C10-25-branched, are respiratory irritants.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin Irritation – Read-across substances to Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, are not corrosives or dermal irritants for rabbit (OECD TG 404). Sixty reliable studies indicated that these hydrocarbon fluids had irritation scores well-below the threshold for classification. Seven studies used occlusive dressing and did not report data which are useful for classification. Seven studies reported results that would require classification. The erythema scores for four of these studies were 2.0, the minimum requirement for classification under the Directive 67/5148/EEC for dangerous substances and Directive 1999/45/EC for preparation. The results from the same four studies do not require classification under the Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). Using qualitative weight of evidence reasoning, Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, are not dermal irritants to rabbits.

 

Application of a read-across substance, under semi-occlusive conditions for 24 hours produced signs of primary dermal irritation in human volunteers in two studies. A third study that utilized a semi-occlusive patch demonstrated no dermal irritation to humans when the substance was applied for 24 hours. Read-across substances for Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, are not irritating to human skin when evaluated in a repeated patch test as a 50% w/w preparation as reported in two studies.  In another study at the same concentration, application to the skin without or in conjunction with UV irradiation did not elicit an irritation response in any of the study participants. 

 

Ocular Irritation - Data from a read-across study show that Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, are not ocular irritants (OECD TG 405) when evaluated in rabbits following a single 0.1 ml ocular instillation. Testing of this substance generally demonstrated a low incidence of conjunctive redness and chemosis. Draize scores were generally low.  All study results indicate that the Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, show no or slight irritation effects on rabbits' eyes.

Respiratory Irritation - No studies were located to indicate that Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, are respiratory irritants.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

SKIN IRRITATION: For Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, the weight of evidence indicates that the erythema and edema scores are below the classification threshold requirements: 2.0, Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparation; 2.3, the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

OCULAR IRRITATION: Ocular lesion scores (24, 48, and 72 average) are below the classification threshold requirements.

Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparation: 0, cornea opacity; 0, iris lesion; >2.5, redness of the conjunctivae; >2.0, oedema of the conjunctivae (chemosis). Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP): 0, cornea opacity; 0, iris lesion; >2.0, redness of the conjunctivae; >2.0, oedema of the conjunctivae (chemosis).

RESPIRATORY IRRITATION - There are no studies that warrent classification as a respiratory irritant under either the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC or under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

As all reliable studies show no irritation effect or irritation effects slight enough not to classify the test materials, Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids do not need to be classified as irritant for skin and eye according to the criteria of Annex VI of Directive 67/548/EEC and EU GHS.