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EC number: 954-225-2 | 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
Endpoint summary
Administrative data
Description of key information
Skin Sensitisation
Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics was not a dermal sensitizer using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406).
Using read-across data from straight run kerosene, C14-C20 aliphatic, (2-30% aromatics) hydrocarbons fluids were determined not to be skin sensitizers using Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406).
Respiratory Sensitisation
no data
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: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Acceptable Buehler test that followed sound scientific principles.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.4 ml of a 1% solution in paraffin oil
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.4 ml of a 1% solution in paraffin oil
- No. of animals per dose:
- 10 animals
- Details on study design:
- 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. The same skin site was used for the first two applications but due to the severe irritation that had occurred in the test and positive control groups a different site was used for the third sensitizing application. 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. The application sites for sensitizing and challenge doses were scored for erythema and edema 24 and 48 hours after patch removal. To assist in the scoring of the response to the final challenge dose the test site was depilated 3 hours prior to examination by using a commercially available depilatory cream. Positive control (2,4-dinitrochlorobenzene), vehicle control and naive control groups were included in this study. Concentrations of positive control were as follows: Sensitizing doses: 0.4 ml of 0.3% w/v in 80% aqueous ethanol Challenge dose: 0.4 ml of 0.1% w/v suspension in acetone.
- Positive control substance(s):
- yes
- Remarks:
- Sensitizing doses:2,4-dinitrochlorobenzene: Concentrations of positive control were as follows: Sensitizing doses: 0.4 ml of 0.3% w/v in 80% aqueous ethanol Challenge dose: 0.4 ml of 0.1% w/v suspension in acetone.
- 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:
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 vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given:comparable to guidelines/standards.
- 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: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Magnusson, B, and Kligman, AM, (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Derm., 52, 268-276.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Acceptable guinea pig maximisation test that followed sound scientific principles.
- Species:
- guinea pig
- Strain:
- other: P
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Shell Toxicology Laboratory, Breeding Unit - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil - Route:
- other: epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil - No. of animals per dose:
- 10 males and 10 females were used in the exposure group
5 males and 5 females were used in the control group - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% w/v in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% w/v in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- positive control
- Remarks on result:
- other: Not specified
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- The test substance did not cause any skin response during the challenge procedure. The test substance is considered not sensitizing.
- Executive summary:
This study examined the skin sensitization potential of Dilutene M5. Groups of 10 male and 10 female guinea pigs were induced with 0.1 % w/v of test substance in corn oil intradermally. 5 male and 5 female guinea pigs served as controls. The topical induction was performed with 50% w/v of test substance in corn oil. A topical challenge was then done with 25% w/v of test substance in corn oil. Animals were then scored for dermal reactions. No reaction was seen in any animal at any time during the experiment. The test substance is not sensitizing to skin.
- 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.
Skin Response After Challenge Procedure
Animal – Exposure Group |
Immediate |
24 hrs |
48 hrs |
Male 1 |
- |
- |
- |
Male 2 |
- |
- |
- |
Male 3 |
- |
- |
- |
Male 4 |
- |
- |
- |
Male 5 |
- |
- |
- |
Male 6 |
- |
- |
- |
Male 7 |
- |
- |
- |
Male 8 |
- |
- |
- |
Male 9 |
- |
- |
- |
Male 10 |
- |
- |
- |
Female 1 |
- |
- |
- |
Female 2 |
- |
- |
- |
Female 3 |
- |
- |
- |
Female 4 |
- |
- |
- |
Female 5 |
- |
- |
- |
Female 6 |
- |
- |
- |
Female 7 |
- |
- |
- |
Female 8 |
- |
- |
- |
Female 9 |
- |
- |
- |
Female 10 |
- |
- |
- |
Control Group |
|||
Male 1 |
- |
- |
- |
Male 2 |
- |
- |
- |
Male 3 |
- |
- |
- |
Male 4 |
- |
- |
- |
Male 5 |
- |
- |
- |
Female 1 |
- |
- |
- |
Female 2 |
- |
- |
- |
Female 3 |
- |
- |
- |
Female 4 |
- |
- |
- |
Female 5 |
- |
- |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no data available for Hydrocarbons, C12-C18, isoalkanes, cyclics, 2-30% aromatics. However, data is available for structural analogues, Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics and kerosene presented in the dossier. 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 Hydrocarbons, C12-C18, isoalkanes, cyclics, 2-30% aromatics based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.
A skin sensitization study (Shell, 1977a) performed according to Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406) found no indication of skin sensitization in guinea pigs for C9-14 aliphatics (2-25% aromatics).
Skin sensitization studies (API, 1985b) performed according to Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406) found no indication of skin sensitization in guinea pigs for straight run kerosene. Using this data as read across, C14-C20 aliphatic, 2-30% aromatic hydrocarbons fluids were determined not to be skin sensitizers using Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There are no reports of respiratory sensitization from Hydrocarbons, C12-C18, isoalkanes, cyclics, 2-30% aromatics in laboratory animals or humans. However, skin sensitization studies utilizing C9-14 aliphatics (2-25% aromatics) and kerosene found no indication of skin sensitization in guinea pigs. With these observations, it is presumed that Hydrocarbons, C12-C18, isoalkanes, cyclics, 2-30% aromatics will not be a respiratory sensitizing agent.
Justification for classification or non-classification
Based on available read across data, Hydrocarbons, C12-C18, isoalkanes, cyclics, 2-30% aromatics 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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