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EC number: 265-205-1 | CAS number: 64743-00-6
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8th Feburary 1993 to 17th March 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with generally accepted scientific principles, with incomplete reporting on methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 40 CFR Part 798, EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing, September 1985.
- Deviations:
- yes
- Remarks:
- : observations were taken according to a different time scale. Day 7 bodyweights were taken on day 9 and female observations on day 4 were not taken.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Buckshire Corp., Perkasie, PA 18944 (U.S.D.A. License # 23-BL).
- Animals were housed and maintained according to the Guide for the Care and Use of Laboratory Animals (NIH Publication No. 86-23).
- Weight at study initiation: 200 - 240 g, variation did not exceed ± 20% on the average weight for either sex.
- Fasting period before study: Overnight prior to dosing.
- Housing: Housed 5 per cage by sex, in stainless steel elevated wire cages.
- Diet (e.g. ad libitum): Wayne® Rodent BLOX® 8604 ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 23.0 ºC.
- Humidity (%): 36 - 54 %.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
IN-LIFE DATES: From: 24th February 1993 To: 10th March 1993 - Route of administration:
- oral: feed
- Vehicle:
- other: 4 ml peanut butter and 2 ml of honey.
- Details on oral exposure:
- - The dosed feed was completely consumed within 24 hours by all animals.
- Doses:
- - 5000 mg/kg bw.
- No. of animals per sex per dose:
- - 5 male and 5 female.
- Control animals:
- not specified
- Details on study design:
- OBSERVATIONS
- Duration of observation period following administration: 14 days. Observations were performed frequently on the day of dosing, then at least once daily.
- Frequency of weighing: Recorded at study initiation, day 9 and at sacrifice.
- Necropsy of survivors performed: Yes, on all animals which were euthanized with carbon dioxide.
- Other examinations performed: Signs of toxicity. - 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
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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.