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EC number: 287-476-5 | CAS number: 85535-84-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-03-02 to 1982-06-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
- Reference Type:
- publication
- Title:
- Summaries of toxicological data. Toxicology of chlorinated paraffins
- Author:
- Serrone DM, Birtley RDN, Weigand W and Millischer R
- Year:
- 1 987
- Bibliographic source:
- Fd Chem Toxicol. 25: 553-562
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- neurobehavioural examination not included
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Alkanes, C10-13, chloro
- EC Number:
- 287-476-5
- EC Name:
- Alkanes, C10-13, chloro
- Cas Number:
- 85535-84-8
- IUPAC Name:
- Alkanes, C10-C13, Chloro
- Details on test material:
- - Name of test material (as cited in study report): C10-12 chlorinated paraffins (58% chlorinated)
- Substance type: technical product
- Physical state: clear, slightly viscous liquid
- Analytical purity: "100% chlorinated paraffins"
- Impurities (identity and concentrations): free hydrochloric acid (HCl) - 7 ppm ; no stabiliser
- Composition of test material, percentage of components: C10-12 chlorinated paraffin (58% chlorinated)
- Purity test date: no data
- Lot/batch No.: R-201-198
- Expiration date of the lot/batch: "Dependent on routine analysis"
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding laboratories, Kingston, New York
- Age at study initiation: 6 weeks
- Weight at study initiation: males - 76 to 125 g; females - 70 to 101 g
- Fasting period before study: none
- Housing: individually in hanging wire-mesh cages
- Diet (e.g. ad libitum): Certified rodent diet #5002
- Water (e.g. ad libitum): ad lib
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 22.8
- Humidity (%): average 60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1982-03-02 To: 1982-06-05
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): Certified rodent diet #5002
- Storage temperature of food: refrigeration - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Diet samples extracted with hexane and extract dried under vacuum. Residue combusted in oxygen, dissolved in water and titrated potentiometricallyagainst standardised silver nitrate solution.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Continuous in the diet
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
10, 100 and 625 mg/kg/day
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
10, 101 and 654 mg/kg/day (males) and 10.3, 102 and 613 mg/kg/dat (females)
Basis:
actual ingested
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, plain diet
- Details on study design:
- Animals randomised to homogeneous groups (Bartlett's Chi-squared test)
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily - morbidity, mortality, skin atonia
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: daily
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: pre-study and week 12
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 4 , 8 and 13 weeks
- Anaesthetic used for blood collection: No
- Animals fasted: Yes (not a week 4)
- How many animals: 10/sex/dose group
- Parameters: Hb, HCT, erythrocyte and platelets count, total and differential leucocytes, MCV, MCH, MCHC, clotting time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 5, 8 and 13 weeks
- Animals fasted: Yes
- How many animals: 10/sex/dose
- Parameters: Na, K, Ca, Cl, P, AlkP, AST, ALT, LDH, BUN, protein, cholesterol, glucose
URINALYSIS: Yes / No / No data
- Time schedule for collection of urine: 4 or 5, 8 and 13 weeks
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters: colour, appearance, sediment, SG, volume, osmolality, pH, protein, glucose, occulu blood, nitrite, ketones, bilirubin, urobilinogen
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: bone marrow smear, liver enzymes - Sacrifice and pathology:
- Gross pathology and histopathological examinations made of a comprehensive range of organs and tissues
- Other examinations:
- Liver total protein, cytochrome P450 and aminopyrine N-demethylase activity determined at autopsy
- Statistics:
- Treatment groups compared with control group by one-way analysis of variance, Barlett's test for homogeneity of variance and appropriate t test. Significance judged using Dunnett's multiple comparison tables. Selected parameters were compared by non-parametric tests.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- slight reduction in food consumption in top-dose females
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: no deaths occurred and no clinical signs were observed except for slight skin atonia in 5 top-dose males, 3 top-dose females and 1 mid-dose female
BODY WEIGHT AND WEIGHT GAIN: body weight gain reduced by 9% in top-dose males
WATER CONSUMPTION: decreased by 11 and 20% in top-dose males and females respectively
HAEMATOLOGY: slight (significant) decrease in erythrocyte count, Hb and HCT in top-dose males and females and Hb in mid-dose females
CLINICAL CHEMISTRY: treatment-related increases seen in total protein (up to 13%), cholesterol (up to 54%), glucose (up to 20%) and BUN (up to 44%) in top- and mid-dose groups
URINALYSIS: Urine volume decreased and specific gravity increased in top-dose males and females.
ORGAN WEIGHTS: absolute and relative liver weight (combined) increased by about 20 and 140% in mid- and top-dose animals, respectively; absolute and relative kidney weights (combined) increased by about 10 and 30% in mid- and top-dose animals, respectively; absolute and relative thyroid weight (combined) increased by about 32% in top-dose animals
HISTOPATHOLOGY: NON-NEOPLASTIC:
Males - hepatocellular hypertrophy, nephritis and thyroid hypertrophy and hyperplasia seen in mid- and top dose animals;
Females - hepatocellular hypertrophy seen in mid- and top-dose animals; renal tubule pigmentation and thyroid hyperplasia and hypertrophy in top-dose animals only
OTHERS:
Males - "slight" dose-related increase in liver protein content seen, with corresponding increases in cytochrome P450 and aminopyrine N-demethylase activity, particulary in top-dose animals.
Females - no effects on liver parameters
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- ca. 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effects on body weight gain, organ weights, urine, liver biochemistry and pathology at higher dose levels
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a guideline study to GLP, no adverse effects were seen in male and female Fischer 344 rats fed a C10-12 chlorinated paraffin (58% chlorinated) for 13 weeks in the diet at 10 mg/kg bw/day. At higher dose levels, effects were seen on body weight gain, organ weights, urinary parameters, blood and liver biochemistry and liver, kidney and thyroid histopathology. The overall no-observed-effect level (NOEL) in the study was 10 mg/kg bw/day.
- Executive summary:
In a 13-week GLP study, similar to OECD Guideline 408, groups of male and female Fischer 344 rats (15/sex/dose) were given a C10-12 chlorinated paraffin (58% chlorinated) in the diet at nominal dose levels of 10, 100 and 625 mg/kg bw/day (actual intakes were 10, 101 and 654 mg/kg bw/day for males and 10.3, 102 and 613 mg/kg bw/day for females). During the study, animals were observed for clinical signs of toxicity. Food and water consumption was determined and haematological and urinary analyses performed. At the end of the feeding period, animals were weighed and a range of organs examined for gross and histopathological changes. Livers were also recovered for biochemical investigations.
No deaths occurred and no clinical signs of toxicity (other than slight skin atonia in top-dose males) were observed during the study. A slight reduction in body weight gain (9% compared to controls) was noted in top-dose males after 13 weeks and a reduction in water consumption was seen in top-dose males and females (11 and 20%, respectively). This was associated with a decrease in urine volume and an increase in specific gravity. Increases in blood total protein (13%), cholesterol (54%), glucose (20%) and urea nitrogen (44%) were also seen in top-dose animals and in glucose (20%), cholesterol and urea nitrogen in mid-dose animals. Statistically significant increases in liver (about 20 and 140%) and kidney (10 and 30%) weights were seen in mid- and top-dose animals, respectively, and in thyroid weight (about 32%) in top-dose animals only. Histopathological changes seen included hepatocellular hypertrophy in both mid- and top-dose males and females, mild chronic nephritis in mid- and top-dose males and renal tubule pigmentation in top-dose females, and thyroid hypertrophy and hyperplasia in mid-dose males and top-dose males and females.
The no-observed-effect level (NOEL) in the rat for the C10-12 chlorinated paraffin (58% chlorinated) investigated in this study is 10 mg/kg bw/day.
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