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EC number: 271-802-8 | CAS number: 68608-82-2 A complex combination of hydrocarbons obtained by the alkylation of benzene with ethene. It consists primarily of ethylbiphenyls, diethylbenzenes with lesser amounts of butylbenzenes and polyethylbenzenes.
- 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 20 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The available data from the reproductive screening study and the repeated dose toxicity studies indicate no effects on reproductive parameters relating to fertility at any dose. There are no effects observed on reproductive organs and no reduction in the number of animals succesfully mating and producing litters in the reproductive screening study.
A standard requirement for a substance manufactured or imported at levels greater than 1000 tonnes per annum is a 2 -generation reproductive study. In this particular case, the REACH substance is used as a High Temperature Heat Transfer fluid in enclosed industrial and commercial heat transfer systems. As such, the potential for exposure to workers and consumers is minimal. In the 3 month inhalation study and the OECD 422, there were no observed effects on fertility or sex organs. Therefore, no additional testing is proposed for assessing reproductive toxicity.
Short description of key information:
OECD 422 combined repeated dose/reproductive, developmental screening study (oral)
1 and 3 month repeated dose inhalation studies.
Effects on developmental toxicity
Description of key information
OECD 422 combined repeated dose/reproductive, developmental screening study (oral)
OECD 414 inhalation teratogenicity study
Both in Rats
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In both the OECD 422 and the teratogenicity study, there were some developmental toxicity effects observed in the high dose animals secondary to maternal toxicity. In the OECD 422, there was some evidence (not statistically significant) of postimplantation loss in the high dose group (320 mg/kg/day). There was also a slight increase in gestation length with the majority of high dose animals delivering litters on Gestation day 22 and 23 rather than 21. One litter was born on gestation day 24, but this was a litter of 1 pup which died before postnatal day 4. In the high dose group, there was also clear evidence of maternal toxicity with decreased body weight and food consumption (systemic LOAEL of 80 mg/kg/day). It is considered that these effects on gestation length are likely to be due to maternal toxicity rather than a specific effect on development or reproductive parameters.
In the teratogenicity study, there was no evidence of embryo or fetal toxicity, but there was a significant increase in bent ribs in the high dose group compared to control. This was considered possibly treatment related; however, no other malformations were observed in this group at levels different to control. Moreover, when total malformations were considered, there was no difference to control. This study identified an increased maternal toxicity in the mid and high dose groups and some evidence of malformations, but only in conjunction of maternal toxicity. Therefore, these effects may be as a result of the general toxicity observed in the Dams rather than specific teratogenicity or developmental toxicity. With the exception of some small changes in malformation incidence, there was no evidence of embryotoxicity or fetotoxicity, that would lead to a conclusion that this substance is developmentally toxic.
It is considered that any developmental toxicity effects are likely a result of general toxicity to the dams rather than evidence of a specific reproductive or developmental effect. Together outcome of OECD 422 study does not warrant the requirement for triggered EOGRTS testing pursuant to Annex IX, Section 8.7.3. Therefore, 'benzene, ethylenated by-products from' is not considered to be a developmental toxicant.
Justification for classification or non-classification
No classification is proposed for reproductive or developmental toxicity for 'benzene, ethylenated by-products from'.
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.
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