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Diss Factsheets
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EC number: 276-737-9 | CAS number: 72623-86-0 A complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of approximately 15cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
- 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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Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1988-09-19 to 1988-10-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions. This is an acceptable, well-documented study report that follows sound scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin sensitisation
- Principles of method if other than guideline:
- Primary Activation Phase: three sites on the back of each participant were chosen as potential contact sites: One for initial contact and two for alternative sites. Investigators were instructed to stop using the initial contact site when a response of Grade 4 or greater was obtained on that site.
Alternate site was used for the challenge phase. - GLP compliance:
- yes
- Remarks:
- GLP applicable to the protection of the privleges and well-being of individuals who participate in patch test procedures.
Test material
- Reference substance name:
- most likely 64742-52-5
- IUPAC Name:
- most likely 64742-52-5
- Reference substance name:
- Severely Hydrotreated Heavy Naphthenic Distillate (Sufficiently Refined, IP 346 <3%)
- IUPAC Name:
- Severely Hydrotreated Heavy Naphthenic Distillate (Sufficiently Refined, IP 346 <3%)
- Test material form:
- other: oily liquid
- Details on test material:
- - Name of test material (as cited in study report): MRD-88-289
- Substance type: Other Lubricant Base Oil, Sufficiently Refined (IP 346 <3%)
- Physical state: Brown viscous liquid
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 112 adult humans
- Sex: Male and Female
- Age: >18 years
- Known diseases: Subjects with known diseases were excluded from the study - Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- 0.2 mL of lubricating base oil was applied dermally under occlusive wrap during the first week and under semi-occlusive wrap thereafter. The participants were treated with lubricating base oil once a day, four days a week, for four weeks. A challenge phase was conducted where the participants were treated with 0.2 ML once a day, four days a week, for one week. Participants were asked to report any change in dermal effects for two weeks after the end of the challenge week. Irritation was scored following The International Contact Research Group System (3) and the Product Investigations, Inc. scoring method.
Results and discussion
- Clinical signs:
- There were no signs of clinical toxicity observed during the primary or challenge phase
- Results of examinations:
- Adverse changes which could be attributed to an irritating activity of the test material were observed in five subjects during the initial week and in eight subjects during the subsequent weeks of the Primary Phase. Faint to moderate erythema was observed in 8 of the 112 volunteers.
There were no clinically significant responses observed during the Challenge Phase. - Outcome of incidence:
- The absence of any clinically significant responses during the challenge phase indicates that the test material does not possess a skin-sensitising propensity.
Applicant's summary and conclusion
- Conclusions:
- The test material did not produce more than a faint to moderate response in the skin of the 112 participants. It was concluded that because the conditions of the study would be more stressful than the exposure to a consumer, contact with the test material should be tolerable to the general population.
- Executive summary:
In a primary dermal irritation study, 112 human adults were dermally exposed to 0.2 mL of Lubricant base oil (MRD-88 -289). The participants were treated with Lubricant base oil (MRD-88 -289) once a day, four days a week, for 13 exposures. A challenge phase was conducted where the participants were treated with 0.2 mL once a day, four days a week, for one week. Participants were asked to report any change in dermal effects for two weeks after the end of the challenge week. Irritation was scored following The International Contact Research Group System (3) and the Product Investigations, Inc scoring method.
In this study, Lubricant base oil (MRD 88 -289) was not a dermal sensitiser based on the small number of slight or mild irritation responses recorded.
This study received a Klimisch score of 2 and is classified as reliable with restriction.
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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