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EC number: 270-735-1 | CAS number: 68477-50-9 A complex combination of hydrocarbons obtained from the distillation of polymerized steam-cracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
- 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
There are no additional studies of relevance in relation to toxicity to reproduction
Additional information
Although no full multigeneration studies exist for this stream category, there are screening assessment data for two C5 non-cyclics streams, Pyrolysis C5 (CAS No 68476 -55 -1) and Hydrotreated C5 (CAS No 68602 -79 -9), and also on one major component 1, 3 pentadiene. Specific marker substances (isoprene, benzene and toluene) and other potential components do not reveal significant reproductive toxicity at any exposure or dose level tested and are not classified under Annex I of the DSD. N-hexane (Classification: DSD Harmful, Xn R62; CLP- Category 2, H361r) causes specific adverse effects on testes, but the maximum level in C5 non-cyclics streams is 0.5% which is below the level that would trigger classification.
Reproductive/developmental toxicity screening studies have been conducted on two C5 non-cyclics category streams. In both studies (HLS, 2004a & b), groups of 12 male and female rats were exposed for a 2-week pre-mating period and throughout mating. Females were then exposed until Day 19 of gestation, allowed to litter and rear their offspring to Day 4 of lactation. Animals were exposed by whole body inhalation exposure for 6 h/day for 7 days/week. In the study with Pyrolysis C5 (HLS, 2004a), at exposure concentrations of 0, 100, 300 or 1000 ppm, there were no effects on reproduction with the no effect level being 1000 ppm. In the study with Hydrotreated C5 (HLS, 2004b) with exposure concentrations of 0, 1000, 3000 and 8500 ppm there was no evidence of reproductive toxicity at the highest concentration tested of 8500 ppm (analysed concentration 8502 ppm).
In
the reproductive/developmental toxicity screening study with
1,3-pentadiene in which doses of 0, 30, 100, 1000 mg/kg day were
administered by oral gavage (EBSI, 1992a), there were no effects on
reproductive parameters at the highest dose level tested, which is the
limit dose for studies of this type.
Short description of key information:
It is recognised that there is a data gap for a multi-generation
study (REACH reference 8.7.3). The applicant submits that this study
does not need to be conducted as the C5 non-cyclics category streams
contain at least 1% isoprene, which is classified as a Cat 3 mutagen and
a Cat 2 carcinogen under DSD and appropriate risk management measures
are implemented (handled in controlled conditions).
Data from reproduction screening studies on two streams within
this category and a third with 1, 3 pentadiene do not indicate a need
for classification.
Effects on developmental toxicity
Description of key information
Based on reported findings, the C5 Non-cyclics Category streams are considered as having minimal potential to produce developmental effects. For the specific component toluene (present in some streams at a maximum of 4%) there is some evidence of developmental toxicity (lower body weight at birth and delayed vaginal opening) at exposure concentrations ≥ 1000 ppm, concentrations which are associated with slight maternal toxicity. The NOAEC for developmental and maternal effects is 600 ppm (2261 mg/m3).
Additional information
Although no developmental toxicity studies exist for this stream category, there are screening assessment data for two C5 non-cyclics category streams, Pyrolysis C5 (CAS No 68476-55-1) and Hydrotreated C5 (CAS No 68602 -79 -9), and also on one major component, 1,3 pentadiene.
For Pyrolysis C5 and Hydrotreated C5 streams, the OECD TG 422 combined repeated dose and reproduction/developmental toxicity studies have been conducted in Sprague Dawley rats (HLS, 2004 a & b). In both studies there were no evidence of developmental toxicity. In conclusion, the NOAELs for developmental toxicity in these screening studies were 1,000 ppm and 8502 ppm respectively.
An OECD TG 422 combined repeated dose and reproduction/developmental toxicity study was conducted in Sprague Dawley rats (oral dosing) was conducted on 1,3 -pentadiene (EBSI, 1992a). The NOAEL for developmental toxicity in this screening study was 1000 mg/kg bw/d, the maximum dose tested.
Specific marker substances (isoprene, benzene and 1,3-butadiene) and other potential components do not reveal significant developmental toxicity at an exposure or dose level tested and are not classified under Annex I of the DSD.
Toluene (Classification: DSD – Harmful Xn, R63; CLP – 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 (2261 mg/m3) (Thiel and Chahoud, 1997).
Justification for classification or non-classification
Based on both data for the streams and the individual components, no classification for reproductive toxicity is warranted.
In relation to developmental toxicity, data on the streams and individual components indicate that classification (Category 2, H361d) is only warranted under CLP where toluene is present at >=3%. Since toluene is present at <5%, no classification under DPD is warranted. If data on a C5 non-cyclics stream indicates a concentration of toluene between >=3% and <5% a classification as Category 2, H361d is warranted.
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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