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EC number: 264-150-0 | CAS number: 63449-39-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Paraffin waxes and Hydrocarbon waxes, chloro
- EC Number:
- 264-150-0
- EC Name:
- Paraffin waxes and Hydrocarbon waxes, chloro
- Cas Number:
- 63449-39-8
- Molecular formula:
- C18H33Cl5 C18H30Cl8 C20H36Cl6 C20H33Cl9 C25H45Cl7 C25H42Cl10 C25H29C23 C30H53Cl9 C30H49Cl13 C30H35Cl27
- IUPAC Name:
- Paraffin waxes and Hydrocarbon waxes (C18 and longer), chloro
- Test material form:
- solid
- Remarks:
- waxy solid
- Details on test material:
- C20-30, 70% Cl (solid) (unstabilized). Electrofine S70.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The appropriate amount of the test material was ground with 1000 grams of Certified Rodent Chow #5002.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- 100 gram samples from the top, middle, and bottom of the batches were tested for homgeneity of test article dispersion prior to use.
- Duration of treatment / exposure:
- 13-weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 900, 3750 mg/kg/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- .
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations checked included: signs of overt toxicity, morbidity and mortality.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: A detailed examination took place before the study was terminated.
BODY WEIGHT: Yes
- Time schedule for examinations: Individual body weights were recorded on days 0 and 5.
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Daily - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, All rats received a post mortem examination at the termination of the study.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- All mortalities were due to blood sampling procedures
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- slightly reduced mean body weight gain in 3750 mg/kg/day males (high concentration of non-nutritive test article may have influenced).
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- indications of increased mean food consumption at 3750 mg/kg/day (high concentration of non-nutritive test article may have influenced).
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- slightly elevated liver transaminase levels at 3750 mg/kg/day (females)
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A general tendency of reduced urine volume with corresponding increases in specific gravity at 3750 mg/kg/day (particularly for males).
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- liver weight increase at 3750 mg/kg/day (females)
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- hypertrophy and cytoplasmic fat vacuolation in liver at 3750 mg/kg/day
- Details on results:
- There were no significant changes in appearance or behavior. Four deaths, including 2 control females, occurred following blood sample collection and were not considered treatment related.
There was evidence of an effect on the liver at 3750 mg/kg/day with slight changed in alanine and aspartate aminotransferase and alkaline phosphate levels, increased liver weights, oil red "O" staining, cytoplasmic fat vacuolation and hepatocellular hypertrophy.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 900 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
- Dose descriptor:
- LOAEL
- Effect level:
- 3 750 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 3 750 mg/kg bw/day (nominal)
- System:
- hepatobiliary
- Organ:
- liver
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL from this study is 900 mg/kg/day for both male and female rats. Effects, primarily in the liver, were noted at 3750 mg/kg/day.
- Executive summary:
The NOAEL from this study is 900 mg/kg/day for both male and female rats. Effects, primarily in the liver, were noted at 3750 mg/kg/day.
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