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Diss Factsheets
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EC number: 272-032-5 | CAS number: 68649-48-9
- 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
Description of key information
ACUTE ORAL TOXICITY
The acute oral toxicity of hydrocarbon waxes was determined to be LD50 >
5000 mg/l according to a GLP compliant study (Gabriel, 1993)
performed according to the standardised
guideline 40 CFR Part 798, EPA Health Effects Testing Guidelines -
Subpart B - General Toxicity Testing.
ACUTE INHALATION TOXCITY
In accordance with Column 2 (adaptation statement) of Annex VIII of
Regulation (EC) 1907/2006 (REACH), the acute dermal toxicity study
required under information point 8.5.2 does not need to be conducted as
the nature of the substance means that it is not potentially inhalable.
ACUTE DERMAL TOXICITY
In accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006
(REACH), the acute dermal toxicity study required under information
point 8.5.3 of Annex VII does not need to be conducted as it is
scientifically unjustified.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
see read-across justifocation in section Chapter 13 - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - No mortalities were observed within the observation period.
- Clinical signs:
- other: - All animals appeared normal throughout the study.
- Gross pathology:
- - No abnormalities were observed in any animal.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test no mortalities were observed at the dose administered, therefore the LD50 is said to be > 5000 mg/kg, no other signs of systemic toxicity were observed. Thus according to Regulation (EC) 1272/2008 the test material does not require classification.
- Executive summary:
In a GLP-compliant study performed following a protocol similar to 40 CFR Part 798 (EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing, September 1985), the acute oral toxicity of the test material was determined. Ten male and female rats were exposed to the test material in a limit test at 5000 mg/kg bw, administered in their feed. No mortalities or systemic signs of toxicity were observed within the 14 hour observation period or at necropsy. Therefore it can be said that the LD₅₀ is > 5000 mg/kg, which according to Regulation (EC) 1272/2008 means the test material does not require classification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The quality of the database is considered to be high.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
ACUTE ORAL TOXICITY
The key study (Gabriel, 1993) is a GLP compliant study which was performed in line with standardised guidelines with a sufficient level of detail to assess the quality of the study. Ten male and female rats were exposed to the test material in a limit test at 5000 mg/kg bw, administered in their feed. No mortalities or systemic signs of toxicity were observed within the 14 hour observation period or at necropsy, therefore it can be said that the LD₅₀ is > 5000 mg/kg. The study was performed to a good standard and was assigned a reliability score of 2 using the principles for assessing data quality as set out in Klimisch (1997).
Four additional supporting studies have been provided (Winckworth, 1989a-d), all of which are in good agreement with the key study. The test material was administered to Sprague Dawley rats in an acute feeding screening study at 5000 mg/kg bw. Five rats per sex were exposed to the dosed feed ad libitum, for a period of 24 hours. Animals were observed for 14 days post administration, bodyweights were measured at regular intervals and at termination all surviving animals were necropsied.
Under the conditions of the test, animals showed no signs of acute toxicity. No deaths or gross macroscopic changes were observed as a result of exposure, and animals showed normal weight gain. The LD₅₀ of the test material can be said to be greater than 5000 mg/kg bw and the test material is considered to be non-toxic. These are all non-GLP studies, which appear to be performed to sound scientific principles. However they are reported with insufficient detail on the methods and materials to assess the quality of the reported results. The studies have therefore been assigned a reliability score of 4 in accordance with Klimisch (1997).
ACUTE INHALATION TOXCITY
The registered substance has low vapour pressure and therefore is unlikely to be available for inhalation as a vapour. The low water solubility and high molecular weight and log Pow value suggest a limited absorption after inhalation. If any amount of the substance reaches the alveoli, this will be likely phagocytised by macrophages, located into the immune surveillance tissues and broken down in lysosomes and peroxisomes.
ACUTE DERMAL TOXICITY
The physical state, high molecular weight and log Pow value, together with the low water solubility indicate very low potential for dermal absorption. Similarly to mineral oils, deposition in the stratum corneum is expected to occur slowly; however, the substance is not sufficiently water soluble to partition from the stratum corneum into the epidermis
As dermal absorption cannot be greater than oral absorption, and the estimate of 2% oral absorption is already a worst-case estimate, no dermal absorption of the registered substance is expected to occur.
Justification for selection of
acute toxicity – oral endpoint
This study was performed to a recognised OECD guideline, in a GLP
certified laboratory and was reported in a good level of detail. It was
assiged a reliability score of 1 in accordance with the criteria
outlined in Klimisch (1997). It was therefore considered suitable to be
the key study for this endpoint.
Justification for classification or non-classification
The results of the acute oral toxicity study are beyond the limits of classification and thus the test material does not require classification in line with Regulation (EC) 1272/2008.
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.