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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

Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 September to 10 December 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A well-reported GLP study, conducted according to good scientific principles; considered acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- The study was conducted to investigate the findings of a previous study (IRDC, 1985) which had shown a high proportion of pup mortality 2-3 weeks after birth (probably as a result of internal haemorrhaging) from mothers fed 6250 ppm Cereclor S52, and to establish the pattern of exposure (in utero and/or lactational) required to cause the effects seen.
- GLP compliance:
- yes
- Type of method:
- in vivo
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: pale yellow liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): no stabiliser present
- Composition of test material, percentage of components: a C14-17 chlorinated paraffin (52% chlorinated)
- Purity test date: no data
- Lot/batch No.: Y01063/003/003
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: diet containing test material stored at -20oC
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River COBS (Wi) [Wistar]
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River UK Ltd, Margate, Kent, UK- Age at study initiation: (P) 10 wks- Weight at study initiation: (P) Males: 295-322 g; Females: 202-230 g; (F1) Both sexes 5.92-6.4 g- Fasting period before study: no data- Housing: stainless steel cages- Diet (e.g. ad libitum): conventional, ad libitum- Water (e.g. ad libitum): filtered tap water, ad libitum- Acclimation period: 10 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 2- Humidity (%): minimum 47- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION- Rate of preparation of diet (frequency): prepared in 3 batches on 17 September and 1 and 30 October 1984- Mixing appropriate amounts with (Type of food): mixing with a small amount of diet then adding this to the bulk of the powdered (meal) diet- Storage temperature of food: -20oC
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- measured by extraction and titration
- Duration of treatment / exposure:
- from 4 weeks pre-mating until either days 10-17 of pregnancy or throughout pregnancy and lactation (see "Any other information on materials and methods incl. tables")
- Frequency of treatment:
- daily in feed
- Duration of test:
- from 4 weeks pre-mating until either days 10-17 of pregnancy or throughout pregnancy and lactation (see "Any other information on materials and methods incl. tables")
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:6250 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:6020, 4618 and 6110 ppm for batches 1, 2 and 3, respectivelyBasis:analytical conc.
- Remarks:
- Doses / Concentrations:3125 mg/kg bw/dayBasis:actual ingested
- No. of animals per sex per dose:
- 50 males and 100 females during pre-mating period135-150 pups per group with approximately equal numbers of each sex
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- See "Any other information on materials and methods incl. tables" for details of the treatment regime.Blood was taken from one pup per litter from all groups on days 3, 4, 5, 8 and 11 and from two pups per litter at termination (day 22) and assayed for the clotting factors VIII and X. Where the volume was sufficient, blood was also analysed for prothombin and platelets measured.
- Statistics:
- The treated group mean was compared to the control group mean using a two-sided Student's t-test for the following parameters: body weight gain, food consumption and food utilisation during the pre-mating period, male and female fertility indices, length of gestation, pre-coital interval, female body weight gain during pregnancy, pup (litter) body weight, live births, sex distribution, litter size, percentage litter deaths, offspring litter weights, percentage factor VIII, percentage factor X and platelet count
Results and discussion
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 3 125 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Feeding a C14-17 chlorinated paraffin (52% chlorination) at about 3125 mg/kg bw/day (only tested dose) to mothers during the lactational period resulted in increased mortality in the pups likely due to internal haemorrhaging.
Observed effects
Applicant's summary and conclusion
- Conclusions:
- Cereclor S52 (a C14-C17 chlorinated paraffin; 52% chlorinated) caused an increased mortality in the neonatal offspring of rats when given in the diet of lactating dams at about 3125 mg/kg bw/day. No increased mortality was evident when Cereclor S52 exposure occurred only during the pre-mating period and pregnancy. No effects on fertility or foetal viability were detected.
- Executive summary:
A study was conducted to investigate whether the findings of a previous study, in which a high proportion of pups whose mothers had been fed Cereclor S52 died 2-3 weeks after birth, was due to in utero and/or lactational pup exposure.
In a good quality study, to GLP, Cereclor S52 (a C14-17 chlorinated paraffin; 52% chlorinated) was given to groups of male and female rats in the diet at 0 or 6250 ppm (about 0 or 3125 mg/kg bw/day) during the pre-mating period and to the females throught pregnancy, or up to days 10-17 of pregnancy or throughout pregnancy and lactation. Groups of control animals received no test substance. After confirmation of mating, the pregnant females were allocated to five groups, as follows:
1. Females fed control diet rearing their own pups.
2. Females fed Cereclor S52 rearing pups from group 3 control females.
3. Females fed control diet rearing pups fostered from group 2 treated females.
4. Females fed Cereclor S52 rearing their own pups.
5. Females fed Cereclor S52 up to days 10-17 of pregnancy, rearing their own pups whilst fed control diet.
Blood samples were obtained from one pup/litter on days 3, 4, 5, 8, and 11, and two pups/litter on day 22 (the day of sacrifice) post-partum and analysed for clotting factors VIII and X. Prothrombin times were also measured at these timepoints and platelet counts on days 11 and 22. Samples of breast milk were taken from lactating dams of groups 1, 2 and 4 on day 14 post‑partum only, and analysed for MCCP.
No treatment-related adverse effects were detected during the pre-mating or pregnancy phases of the study. Between 11 and 13 litters were delivered for each group.The offspring from groups 2 and 4, in which the lactating mothers were given Cereclor S52, showed higher pup mortality, first seen between post-natal days 6 and 11, and associated with internal haemorrhages in the pups. This suggests that lactational exposure was responsible for the mortalities. A decrease in clotting factor X was seen only in pups exposed lactationally; the decrease was 45 and 63% in group 2 and 4, respectively.
Based on the decrease observed in factor X, the investigators proposed that Cereclor S52 was either transferred to the breast milk resulting in a disruption of the vitamin K-dependent clotting system in the pups and/or that the test substance caused less vitamin K to be available in the breast milk due to treatment-related effects in the mothers.
In conclusion, feeding Cereclor S52 at about 3125 mg/kg bw/day to mothers during the lactational period resulted in increased mortality in the pups likely due to internal haemorrhaging. No such an effect was reported when Cereclor S52 was administered prior to, and during pregnancy, in the absence of lactational exposure.
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