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Diss Factsheets
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EC number: 919-006-8 | 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
Based on available read across data (Buehler test (OECD TG 406)), Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) is not considered to be a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to or similar to guideline study OECD 406: GLP.
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 ml of 0.1% w/v suspension in acetone.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 ml of 0.1% w/v suspension in acetone.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
This data is being read across from the source study that tested Kerosene based on analogue read across.
0.4 ml undiluted test material was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
The skin reactions after challenge applications were:
Test group - No dermal irritation in any animal;
Naive control group - Very slight erythema in two animals, no reaction in the other eight animals;
Vehicle control group - A very slight erythema in one animal, no reaction in the other nine animals;
Positive control group - Very slight to severe irritation in all 20 animals. The reaction in 19 animals exceeded the highest reaction observed in the naive positive control animals;
Naive positive control group - 5 of 20 animals exhibited very slight erythema, the other 15 animals had no skin reaction.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no data available for Hydrocarbons, C16-C20 n-alkanes, isoalkanes, cyclics, aromatics (2-30%). However, data is available for structural analogue, Kerosene. An additional case study on sensitisation in humans for structural analogue, Hydrocarbons, C14 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) is also available. Petroleum substances of similar carbon number and aromatic content, principally kerosene and jet fuel, are typically in the range of C9-C16. These substances also contain similar types of molecules in similar proportions to those in C14-C20 aliphatic [2-30% Aromatics] Hydrocarbon solvents. In general, hydrocarbon solvents are more highly refined than petroleum substances. Accordingly, the petroleum substances typically represent a “worse case” with respect to hydrocarbon solvents and can be used for read across on that basis. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.
Kerosene
In a key Buehler test (API, 1985b) 0.4 ml undiluted test material (Kerosene; Straight run kerosene) was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Sensitisation data (humans)
Hydrocarbons, C14 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%)
In a supporting case study, a 64 year old woman had a history of an eczematous rash after the application of sunscreen. The rash had appeared after 3 days of application of the sunscreen over the face, neck, and limbs and had been very pruritic. Patch tests with the European standard series gave positive reactions to formaldehyde, quaternium-15, imidazolidinyl urea, and diazolidinl urea. The ingredients of the sunscreen were obtained from the manufacturers and patch tests were performed. There were positive reactions to isohexadecane 10% alcohol + at D2 and D4 and isopropyl myristate 10% alcohol + at D4. Both of these substances tested negatively in 20 controls. To the knowledge of the investigators, this is the first and only case report of allergic contact dermatitis from both isohexadecane and isopropyl myristate.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There are no reports of respiratory sensitisation from Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) in laboratory animals or from structural analogues in humans. However, the read across skin sensitisation study found no indication of skin sensitisation in guinea pigs. With these observations, it is presumed that Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) will not be a respiratory sensitising agent.
Justification for classification or non-classification
Based on available read across data, Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) does not meet the criteria for classification as a skin or respiratory sensitizer 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.
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