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Diss Factsheets
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EC number: 950-299-5 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited reporting in review, including no details as to whether study performed to test guidelines or GLP, however study considered adequate for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The toxicological effects of chlorinated paraffins in mammals
- Author:
- Birtley RDN, Conning DM, Daniel JW, Ferguson DM, Longstaff E and Swan AAB
- Year:
- 1 980
- Bibliographic source:
- Toxicol. Appl. Pharmacol. 54: 514-525
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
- Principles of method if other than guideline:
- Groups of at least 3 male and/or female rats were given a single oral dose of one of several C14-17 chlorinated paraffins (ranging from 51-60% chlorination) and observed for clinical signs for up to 14 days.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Alkanes, C14-17, chloro
- EC Number:
- 287-477-0
- EC Name:
- Alkanes, C14-17, chloro
- Cas Number:
- 85535-85-9
- Molecular formula:
- Substance is a range of chlorinated isomers of C14 to C17 paraffin
- IUPAC Name:
- Alkanes, C14-17, chloro
- Details on test material:
- - Name of test material (as cited in study report): C14-17 chlorinated paraffins (51-60% chlorination)
- Substance type: technical product
- Purity: no data
- Composition of test material, percentage of components: C14-17 n-paraffins (51-60% chlorination)
- Impurities: no details on presence/absence of a stabiliser
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Animal Breeding Unit, Imperial Chemical Industries Ltd, Alderley Park, UK- Age at study initiation: not reported- Weight at study initiation: between 125 and 250 g- Fasting period before study: 16 hours- Housing: no data- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: As supplied or in eg olive oil
- Details on oral exposure:
- no data
- Doses:
- Not specified, but between 0.5 and 10 g/kg bw for all of the various chlorinated paraffins studied.
- No. of animals per sex per dose:
- At least three
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: animals obseved "regularly" for abnormal clinical signs- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, histopathology of certain organs considered to have been affected by treatment
- Statistics:
- Not reported
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No confidence intervals given
- Mortality:
- No deaths observed
- Clinical signs:
- other: Clinical signs of toxicity were not mentioned in respect of the C14-17 chlorinated paraffins, being confined "mainly" to rats which received a high dose (4 g/kg bw or above) of the C10-13 chlorinated paraffins. They included piloerection, muscular incoord
- Gross pathology:
- The general comment was that hepatocellular vacuolation and occassional necrotic foci were seen in the liver and cloudy swelling of some inner cortical cells was seen in the kidney. These effects were mainly seen in the animals treated with the C10-13 chlorinated parafins, which showed signs of toxicity, and were not mentioned specifically for the C14-17 chlorinated paraffin-treated rats.
- Other findings:
- - Other observations: occasional inflamation of the gastric mucosa was observed following administration of "some chlorinated paraffins" (not further specified in review).
Any other information on results incl. tables
No data is presented on which specific chlorinated paraffin the effects were attributed, the dose levels at which the effects occurred, or on whether the test material contains added stabilizer (0.2% epoxidized vegetable oil). It is not possible to delineate the results of the work on SCCPs and MCCPs
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- No deaths or other severe adverse effects were seen in rats given single unspecified doses of various C14-17 chlorinated paraffins (ranging from 51-60% chlorination) by stomach tube (from between 0.5 and 10 g/kg bw) and observed for 14 days. The acute oral LD50 was reported as greater than 4 g/kg bw
- Executive summary:
Groups of 3 or more male and/or female Wistar rats were given single doses of various C14-17 chlorinated paraffins (ranging from 51-60% chlorination), including Cereclor S52 (a C14-17 chlorinated paraffin, with average chlorination of 52%) by stomach tube and observed for abnormal clinical signs for up to 14 days. At the end of this observation period, animals were autopsied and selected tissues/organs were examined histologically and microscopically. Dose levels varied from 0.5 to 10 g/kg bw, administered with or without a vehicle such as olive oil. A total of 8 experiments were carried out with the C14-17 chlorinated paraffins.
No mortalities were observed for any of the tested chlorinated paraffins, although various abnormalities were noted, including certain adverse clinical signs (piloerection, muscular incoordination and urinary/fecal incontinence) and histopathological changes (including hepatocellular vacuolation and focal necrosis in the liver and cloudy swelling of inner cortical cells in the kidneys). Birtley et al. (1980) comment that the toxic effects were slight and that the clinical signs generally disappeared within 7 days.
The limitations in reporting do not allow the observed effects to be attributed to any specific chlorinated paraffin sample or to ascertain at what dose level(s) the effects occurred. However, the acute oral LD50 in this study is reported as greater than 4 g/kg bw, and therefore C14-17 chlorinated paraffins would not be classified for acute oral toxicity under EU CLP or DSD regulations.
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