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EC number: 287-477-0 | CAS number: 85535-85-9
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-01-05 to 1982-02-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Good quality study to GLP; considered adequate for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- does not include the pre-implantation phase or use dose levels with some maternal/developmental toxicity
- GLP compliance:
- yes
- 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): Cereclor S52
- Substance type: technical product
- Physical state: clear, slightly viscous liquid
- Analytical purity: no data
- Composition of test material, percentage of components: C14-17 chlorinated paraffin; 51.8% chlorinated.
- Impurities (identity and concentrations): No stabiliser
- Lot/batch no: 306
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Dutch
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Langshaw Farms, Augusta, Michigan, USA- Age at study initiation: approx. 7 months- Weight at study initiation: between 1.9 and 3.0 kg- Fasting period before study: no- Housing: Individually in suspended wire cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 50 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22-23- Humidity (%): 43-51- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Weighed amounts of chlorinated paraffin were mixed with corn oil vehicle by shaking. Dosing solutions were prepared daily.VEHICLE- Justification for use and choice of vehicle (if other than water): test material soluble in corn oil- Concentration in vehicle: 20, 60 and 200 mg/ml (nominal)- Amount of vehicle (if gavage): 0.5 ml/kg bw- Purity: "100% pure"
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- not done
- Details on mating procedure:
- Rabbits artificially inseminated using semen from male rabbits of same strain and source. Day of insemination designated day 0 of gestation.
- Duration of treatment / exposure:
- days 6 to 27 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- Dams sacrificed on day 28 of gestation
- No. of animals per sex per dose:
- 16 females/dose level
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on data from two range-finding studies
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes - Time schedule: Twice dailyDETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: once daily for signs of toxicityBODY WEIGHT: Yes - Time schedule for examinations: days 0, 6, 12, 18, 24 and 28 of gestationPOST-MORTEM EXAMINATIONS: Yes - Sacrifice on gestation day # 28- Organs examined: uterus and organs visible in the abdominal and thoracic cavityOTHER: abdominal adipose tissue recovered for analysis of test material concentration
- Ovaries and uterine content:
- At sacrifice the numbers and location of viable and non-viable fetuses, early and late resorptions and the number of total implantations and ovarian corpora lutea were determined
- Fetal examinations:
- All fetuses were weighed and examined for external malformations. Each fetus was dissected, internally sexed and examined for visceral malformations and following maceration in potassium hydroxide and staining, examined for skeletal malformations (although the draft RAR (EU, 2008) reports that only half of the fetuses were examined for visceral and half for skeletal abnormalities).
- Statistics:
- Fetal sex distribution and numbers of litters with malformations compared using Chi-squared test or Fisher's exact test. Numbers of non-viable fetuses, early and late resorptions and post-implantation losses compared by the Mann-Whitney U-test. Mean fetal body weight, number of viable fetuses, total implantations and corpora lutea were compared by analysis of variance, Bartlett's test and the appropriate t-test.
- Indices:
- No data
- Historical control data:
- yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effectsDetails on maternal toxic effects:Three dams died during the study (one in the control group, one in the 10 and one in the 30 mg/kg bw/day groups). Abortions occurred in the control group (1 dam) and in the 30 (2 dams) and 100 (2 dams) mg/kg bw/day groups. The mortalities and pattern of abortions seen was not indicative of a treatment-related effect.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effectsDetails on embryotoxic / teratogenic effects:No adverse effects seen. The number of viable foetuses was significantly increased in the 30 mg/kg bw/day dose group, but within the historical control range for this parameter.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No treatment-related adverse effects were seen in pregnant rabbits given a C14-17 chlorinated paraffin (52% chlorinated) by oral gavage in corn oil at dose levels up to 100 mg/kg bw/day on gestational days 6 to 27, or on their foetuses examined on gestational day 28. Therefore, the test material was not toxic to development in rabbits under the conditions of this study.
- Executive summary:
Groups of 16 pregnant female rabbits were given unstabilised Cereclor S52 (a C14 -17 chlorinated paraffin; 52% chlorinated) by oral gavage in corn oil at dose levels of 0, 10, 30 and 100 mg/kg bw/day on gestational days 6 to 27 and sacrificed on gestational day 28. At this time the dams were examined for the numbers and positions of viable and non-viable foetuses, resorption sites, and total number of implantations and ovarian corpora lutea. All foetuses were examined for external malformations, and for visceral and skeletal malformations (although the draft RAR (EU, 2008) reports that only half of the fetuses were examined for visceral and half for skeletal abnormalities).
No significant treatment-related mortalities or clinical signs of toxicity were seen in the dams and no treatment-realated malformations were seen in the foetuses. The level of abortions (1, 2 and 2 in the 0, 30 and 100 mg/kg bw/day dose groups respectively) and the increased number of viable foetuses in the 30 mg/kg bw/day dose group were not considered to be of toxicological significance.
The results of this study suggest that Cereclor S52 did not adversely effect the development of rabbits at up to 100 mg/kg bw/day (the highest tested dose), a dose level which failed to induce signs of maternal toxicity.
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