Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 941-627-8 | 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: expert assessment
- Type of information:
- other: expert assessment
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An expert assessment was performed using data derived from other light fuel oils, together with assessment of components known to be present in the UVCB.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- An expert assessment was performed using data derived from other light fuel oils, together with assessment of components known to be present in the UVCB.
- GLP compliance:
- no
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The maximum tolerated dose in almost all studies and reviews
- Reproductive effects observed:
- not specified
- Conclusions:
- The evidence indicates that the oil is unlikely to cause toxicity to the reproduction via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The observations on toxicity to the reproduction are considered to be related to systemic toxicity.
- Executive summary:
An assessment of the toxicity to the reproduction of the substance was determined via an assessment of the components of the substance. Two methods of assessment have been used; one uses data relating to light distillate oils with similar composition and the second is to review know components of the UVCB substance to consider if there are any substance present thought likely to be toxic to reproduction. The evidence indicates that the oil is unlikely to cause reproductive toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The observations on toxicity to the reproduction are considered to be related to systemic toxicity.
Reference
This is not an exhaustive review of all oil types considered similar to the UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped but the weight of evidence from review publications and other public sources suggest that there is a low risk of reproductive and developmental effects. There is no evidence across the range of oils reviewed to show that repeated dermal application leads to developmental toxicity at levels tolerated by parental rats.
Very limited data on oral or inhalation exposure that relate to reproductive or developmental endpoints have been found, but it is recognised that dermal exposure is not only the most relevant for human exposure.
The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals; at dose levels in excess of 100 mg/kg/day, there are indications of reduced food intake and reduced weight and at higher dose levels, up to the maximum reported 1000 mg/kg/day, there is decreasing size of foeti and pups and in some cases, increase in the number of resorptions. The developmental observations are considered to be related to parental toxicity.
In the review of known components, it was not possible to find data on every specific component, but component types were assessed. Only toluene is known to have effects on development, and this is at high levels of exposure. Toluene is present at less than 1% in the substance to be registered and is not considered to influence the overall classification.
It is not considered acceptable to perform further reproduction toxicity tests on UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped in view of the wealth of data on similar light oils with high aromatic content.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
Additional information
An assessment of the toxicity to the reproduction of the substance was determined via an assessment of the components of the substance. Two methods of assessment have been used; one uses data relating to light distillate oils with similar composition and the second is to review know components of the UVCB substance to consider if there are any substance present thought likely to be toxic to reproduction. The evidence indicates that the oil is unlikely to cause reproductive toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The observations on toxicity to the reproduction are considered to be related to systemic toxicity.
Short description of key information:
The evidence indicates that the oil is unlikely to cause toxicity to the reproduction via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The observations on toxicity to the reproduction are considered to be related to systemic toxicity. Limited data was available via the inhalation and oral route, but it is recognised that exposure to the oil will not be via the dermal route alone.
Justification for selection of Effect on fertility via dermal route:
An expert assessment was performed using data derived from other light fuel oils, together with assessment of components known to be present in the UVCB.
Effects on developmental toxicity
Description of key information
The evidence indicates that the oil is unlikely to cause pre-natal development toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The developmental observations are considered to be related to parental toxicity. Limited data was available via the inhalation and oral route, but it is recognised that exposure to the oil will not be via the dermal route alone.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An assessment of the prenatal developmental toxicity of the substance was determined via an assessment of the components of the substance.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- An assessment of the prenatal developmental toxicity of the substance was determined via an assessment of the components of the substance.
- GLP compliance:
- no
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The evidence indicates that the oil is unlikely to cause pre-natal development toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The developmental observations are considered to be related to parental toxicity.
- Executive summary:
An assessment of the prenatal developmental toxicity of the substance was determined via an assessment of the components of the substance. Two methods of assessment have been used; one uses data relating to light distillate oils with similar composition and the second is to review know components of the UVCB substance to consider if there are any substance present thought likely to be toxic for reproduction. The evidence indicates that the oil is unlikely to cause pre-natal development toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The developmental observations are considered to be related to parental toxicity.
Reference
This is not an exhaustive review of all oil types considered similar to the UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped but the weight of evidence from review publications and other public sources suggest that there is a low risk of reproductive and developmental effects. There is no evidence across the range of oils reviewed to show that repeated dermal application leads to developmental toxicity at levels tolerated by parental rats.
Very limited data on oral or inhalation exposure that relate to reproductive or developmental endpoints have been found, but it is recognised that dermal exposure is not only the most relevant for human exposure.
The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals; at dose levels in excess of 100 mg/kg/day, there are indications of reduced food intake and reduced weight and at higher dose levels, up to the maximum reported 1000 mg/kg/day, there is decreasing size of foeti and pups and in some cases, increase in the number of resorptions. The developmental observations are considered to be related to parental toxicity.
In the review of known components, it was not possible to find data on every specific component, but component types were assessed. Only toluene is known to have effects on development, and this is at high levels of exposure. Toluene is present at less than 1% in the substance to be registered and is not considered to influence the overall classification.
It is not considered acceptable to perform further reproduction toxicity tests on UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped in view of the wealth of data on similar light oils with high aromatic content.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
Additional information
An assessment of the prenatal developmental toxicity of the substance was determined via an assessment of the components of the substance. Two methods of assessment have been used; one uses data relating to light distillate oils with similar composition and the second is to review know components of the UVCB substance to consider if there are any substance present thought likely to be toxic for reproduction. The evidence indicates that the oil is unlikely to cause pre-natal development toxicity via the dermal route. The maximum tolerated dose in almost all studies and reviews is about 50 mg/kg/day, above which local dermal effects start to reduce the health of the adult animals. The developmental observations are considered to be related to parental toxicity. Limited data was available via the inhalation and oral route, but it is recognised that exposure to the oil will not be via the dermal route alone.
Justification for selection of Effect on developmental toxicity: via dermal route:
An expert assessment was performed using data derived from other light fuel oils, together with assessment of components known to be present in the UVCB.
Justification for classification or non-classification
The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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.
