Registration Dossier

Diss Factsheets

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Description of key information

Skin Irritation – Isoparaffinic, normal paraffinic, and mixed C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids are not corrosives or dermal irritants for rabbit (OECD TG 404).  A total of 60 studies were examined that covered these substances in the category.  Forty-six 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 67/548/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, the isoparaffinic, normal paraffinic, and mixed C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids are not dermal irritants to rabbits.

Ocular Irritation - C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids are not irritating for rabbits (OECD TG 405). A total of 43 studies were examined that covered all substances in the category.  All study results indicate that the C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids are not ocular irritants to rabbits.

Respiratory Irritation - No studies were located to indicate that C9-C14 aliphatic, < 2% aromatics 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 – Isoparaffinic, normal paraffinic, and mixed C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids are not corrosives or dermal irritants for rabbit (OECD TG 404). A total of 60 studies were examined that covered these substances in the category. Forty-six 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, the isoparaffinic, normal paraffinic, and mixed C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids are not dermal irritants to rabbits.

 

Application of neat C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids 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 neat C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids were applied for 24 hours. C9-C14 aliphatic, < 2% aromatic 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 of C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids to the skin without or in conjunction with UV irradiation did not elicit an irritation response in any of the study participants. 

 

Ocular Irritation - C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids are not ocular irritants (OECD TG 405) when evaluated in rabbits following a single 0.1 ml ocular instillation. Testing of C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids generally demonstrated a low incidence of conjunctive redness and chemosis. Draize scores were generally low. A total of 43 studies were examined that covered all substances in the category. All study results indicate that the C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids are not irritating for rabbits.

Respiratory Irritation - No studies were located to indicate that C9-C14 aliphatic, < 2% aromatics are respiratory irritants.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

SKIN IRRITATION: For isoparaffinic, normal paraffinic, and mixed C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids, the weight of evidence indicates that the erythema and edema scores (24, 48, and 72 average) 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).

Categories Display