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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Endpoint summary
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.
Cycloparaffinic C9-C14 aliphatic, <2% aromatic hydrocarbon fluids are not corrosives but are considered dermal irritants to rabbits (OECD TG 404) and to humans. A total of 7 studies were examined. Six studies were performed with rabbits and reported results that would require classification. The final study was performed using human volunteers and also reported evidence of skin irritation. Using qualitative weight of evidence reasoning, cycloparaffinic C9-C14 aliphatic, <2% aromatic hydrocarbon fluids are dermal irritants to rabbits (OECD TG 404) and to humans.
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
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.
Cycloparaffinic C9-C14 aliphatic, <2% aromatic hydrocarbon fluids are not corrosives but are considered dermal irritants to rabbits (OECD TG 404) and to humans. A total of 7 studies were examined. Six studies were performed with rabbits and reported results that would require classification. The final study was performed using human volunteers and also reported evidence of skin irritation. Using qualitative weight of evidence reasoning, cycloparaffinic C9-C14 aliphatic, <2% aromatic hydrocarbon fluids are dermal irritants to rabbits (OECD TG 404) and to humans.
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.
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).
For cycloparaffinic C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids, erythema and edema scores (24, 48, and 72 average) are above the classification threshold requirements: 2.0, Directive 67/518/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). This finding warrants classification of the test material as a skin irritant (R38) under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. This finding warrants classification of the test material as a Category 2 dermal irritant under 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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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