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EC number: 271-266-5 | CAS number: 68527-26-4 A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80°C to 218°C (176°F to 424°F).
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
It is recognised that there is a data gap for an Extended One-Generation Reproductive Toxicity study (REACH reference 8.7.3). The applicant submits that this study does not need to be conducted as High Benzene Naphtha streams contain at least 0.1% benzene which is known to be mutagenic Category 1B and carcinogenic Category 1A.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Adequate information is available on the component substances to characterise the reproductive hazards of these streams after ingestion.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Adequate information is available on the component substances to characterise the reproductive hazards of these streams after inhalation.
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Adequate information is available on the component substances to characterise the reproductive hazards of these streams after skin contact.
Additional information
The available data on stream marker constituents: benzene, cyclohexane, ethylbenzene, and xylene do not indicate reproductive toxicity of a severity that would warrant classification. Rep Cat 2 (H361) self-classification is applied to DCPD based on the WoE on a number of studies that suggest that it produced foetotoxic effects at doses at or below those that produced clear signs of maternal toxicity. Hexane is suspected to have effects on fertility:
n-Hexane (Classification: Category 2, H361f): Testicular atrophy in male rats is seen after repeated dose oral or inhalation exposure to generally high doses of n-hexane which also produce peripheral neuropathy and other systemic effects.
The following information is taken into account for any hazard / risk assessment:
It is recognised that there is a data gap for an Extended One-Generation Reproductive Toxicity study (REACH reference 8.7.3). The applicant submits that this study does not need to be conducted as High Benzene Naphtha streams contain at least 0.1% benzene which is known to be mutagenic Category 1B and carcinogenic Category 1A.
Justification for selection of Effect on fertility via oral route:
n-Hexane and DCPD present in some streams, have been shown to adversely affect fertility. However, controls to protect against the carcinogenicity of benzene (present in all streams at 0.1% and above) will mitigate
such risks to reproduction.
Justification for selection of Effect on fertility via inhalation route:
n-Hexane present in some streams, has been shown to adversely affect fertility. However, controls to protect against the carcinogenicity of benzene (present in all streams at 0.1% and above) will mitigate such risks to reproduction.
Justification for selection of Effect on fertility via dermal route:
n-Hexane present in some streams, has been shown to adversely affect fertility. However, controls to protect against the carcinogenicity of benzene (present in all streams at 0.1% and above) will mitigate such risks to reproduction.
Effects on developmental toxicity
Description of key information
It is recognised that there is a data gap for developmental toxicity studies in two species (REACH reference 8.7.2). The applicant submits that these studies do not need to be conducted as High Benzene Naphtha streams contain at least 0.1% benzene which is known to be mutagenic Category 1B and carcinogenic Category 1A and appropriate risk management measures are implemented (handled in controlled conditions).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Adequate information is available on the component substances to characterise the reproductive hazards of these streams after ingestion.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Adequate information is available on the component substances to characterise the reproductive hazards of these streams after inhalation.
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Adequate information is available on the component substances to characterise the reproductive hazards of these streams after skin contact.
Additional information
The available data on the specific marker constituents: benzene, isoprene, cyclohexane, ethylbenzene, and xylenes do not reveal developmental toxicity of a severity that would warrant classification. Rep Cat 2 (H361) self-classification is applied to DCPD based on the WoE on a number of studies that suggest that it produced developmental effects at doses at or below those that produced clear signs of maternal toxicity. Toluene is classified for possible developmental toxicity:
Toluene (Classification: Category 2, H361d): There is no evidence that toluene produces malformation in animals or humans. There is some evidence of developmental toxicity (lower body weight at birth and delayed vaginal opening) at toluene exposure concentrations≥1000 ppm, concentrations which are associated with slight maternal toxicity. The NOAEC for developmental and maternal effects is 600 ppm (2261mg/m3) (Thiel and Chahoud, 1997).
Styrene (Classification: Category 2, H361d):Styrene is classified in Annex VI of the CLP regulation as suspected of being damaging the unborn child.
Justification for selection of Effect on developmental toxicity: via oral route:
Toluene and DCPD present in some streams, have been shown to adversely affect the foetus. However, controls to protect against the carcinogenicity of benzene (present in all streams at 0.1% and above) will mitigate such risks to foetal development.
Justification for selection of Effect on developmental toxicity: via inhalation route:
Toluene, present in some streams, has been shown to adversely affect the foetus. However, controls to protect against the carcinogenicity of benzene (present in all streams at 0.1% and above) will mitigate such risks to foetal development.
Justification for selection of Effect on developmental toxicity: via dermal route:
Toluene, present in some streams, has been shown to adversely affect the foetus. However, controls to protect against the carcinogenicity of benzene (present in all streams at 0.1% and above) will mitigate such risks to foetal development.
Justification for classification or non-classification
There are sufficient data available on component substances to conclude that streams within the High Benzene Naphtha category that contain less than 3% toluene, n-hexane, DCPD, or styrene are not reproductive toxicants and do not require a label for this endpoint. High Benzene Naphtha streams which contain≥3% DCPD should be classified as Category 2, H361 according to Reg (EC) 1272/2008. Streams that contain ≥3% n-hexane should be classified as Category 2, H361f according to Reg (EC) 1272/2008. Streams that contain ≥3% toluene or styrene should be classified as Category 2, H361d according to Reg (EC) 1272/2008.
Additional information
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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