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EC number: 926-141-6 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to or similar to OECD guideline 408: GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics
- Molecular formula:
- None available - not a single isomer
- IUPAC Name:
- Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics
- Details on test material:
- - Name of test material (as cited in study report): MRD 77-12
- Physical state: clear liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley Inc.
- Age at study initiation: Approximately 6 weeks
- Weight at study initiation: Males: 156.2-223.2 g; Females: 136.2-170.9 g
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): maintained range of 68-76
- Humidity (%): maintained range of 40-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: October 24, 1990 To: September 27, 1991
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test material was diluted in vehicle at the following concentration to ensure a 5ml/kg dose volume at all dose levels:
-Group 2=0.1g/kg (2.0% w/v)
-Group 3= 0.5g/kg (10% w/v)
-Group 4 and 5= 1.0g/kg (20.0% w/v)
VEHICLE
- Amount of vehicle (if gavage): 5ml/kg - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- The test material mixtures and control were administered by oral gavage at a dose volume of 5ml/kg, 7 days per week for a period of 13 weeks.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.1g/kg (2.0w/v)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
0.5g/kg 10% w/v)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1.0g/kg (20% w/v)
Basis:
actual ingested
- No. of animals per sex per dose:
- All groups consisted of 20 mice (10males; 10 females)
Group 1=Control group (
Group 2= 0.1g/kg (2.0% w/v)
Group 3= 0.5g/kg (10% w/v)
Groups 4=1.0g/kg (20% w/v).
Group 5 (satellite)= 1.0g/kg (20% w/v). - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Rationale for selecting satellite groups: observed for reversibility, persistence or delayed occurrence of toxic effects
- Post-exposure recovery period in satellite groups: 28 days
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Clinical observations were made daily. Clinical laboratory studies were performed on all animals pre-dose, interim (day 32 for males, and day 33 for females), and at main study termination. For the satellite animals, clinical laboratory studies were also performed on the day of recovery sacrifice.
BODY WEIGHT: Yes
- Time schedule for examinations: prior to dosing (pretest), on the day of dose initiation (Day 0), and weekly thereafter. Body weights were also recorded at sacrifice or death.
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Prior to study initation and during the final week of the main study
- Dose groups that were examined: all dose groups
HAEMATOLOGY: Yes
- Time schedule for collection of blood: pre-dose, interim (day 32 for males, and day 33 for females), and at main study termination. Also on day of recovery sacrifice for the satellite animals.
- Anaesthetic used for blood collection: Yes-methoxyflurane
- Animals fasted: yes
- How many animals: all animals
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: pre-dose, interim (day 32 for males, and day 33 for females), and at main study termination. Also on day of recovery sacrifice for the satellite animals.
- Animals fasted: yes
- How many animals: all animals
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
The necropsy included an examination of the external surface of the body, all orifices, and the cranial, thoracic, and abdominal cavities and their contents. The kidneys, liver, ovaries, tested, adrenals, and brain were weighed prior to fixation.
HISTOPATHOLOGY: Yes
-erythrocyte count
-hematocrit
-hemoglobin
-leukocyte count
-mean corpuscular volume
-mean corpuscular hemoglobulin
-mean corpuscular hemoglobulin concentration
-platelets
-reticulocyte count
SERUM CHEMISTRY:
-total bilirubin
-albumin
-blood urea nitrogen
-calcium
-cholesterol
-creatinine
-electrolytes
-glucose
-total protein
-triglycerides
-phosphorous
-gamma glutamyl transferase
-serum aspartate aminotransferase
-serum alanine aminotransferase - Statistics:
- The following parameters were statistically analyzed for significant differences:
-mean hematology parameters
-mean serum chemistry parameters
- mean organ weights
- mean organ to body weight ratios
- mean body weights
- mean food consumption.
Comparisons were limited to within sex analysis.
Statistical evaluation of equality of means was done by an appropriate one way analysis of variance and a test for ordered response in the dose groups. Bartlett's test was performed first. If the dose groups had equal variance, a parametric method was used. Otherwise, nonparametric techniques were used.
Parametric procedures involved a standard one way ANOVA using the F distribution. If significant differences among the means were indicated, Dunnett’s test was used to determine significant differences from control. In addition, a standard regression analysis for linear response in the dose groups and linear lack of fit were performed.
Nonparametric procedures involved the test of equality of means using the Kruskal-Wallis test. If significant differences were indicated, Dunn’s Summed Rank test was used. In addition, Jonckheere’s test for monotonic trend in the dose response was performed.
The statistical t-test was used to compare the satellite group’s main study termination and recovery termination values. In addition, the t-test was used to compare the satellite group’s and the high dose group's relative organ weights. The t-test was also used to evaluate recovery.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- HISTOPATHOLOGY: NON-NEOPLASTIC
Microscopic changes were observed in the kidneys and liver of male rats and in the livers of female rats. The treatment-related effects in the kidney were characterized predominantly by accumulations of hyaline droplets in the cytoplasm of the proximal tubules of the cortex. An increased incidence of multifocal cortical tubular basophilia with changes consistent with both degeneration and regeneration of the tubular epithelium also was present as well as dilated medullary tubules with granular casts. These renal changes were observed only in males in all doses necropsied immediately after the 90-day treatment period. The incidence and severity of these changes generally occurred in a dose-related manner. After the reversibility period, there were still residual changes but of a lesser degree. Dilated tubules with granular casts in the medulla and an increased incidence of multifocal cortical tubular basophilia were noted. No-treatment related microscopic changes were observed in the kidneys of the female rats.
Changes in the liver consisted of a minimal to slight centrilobular hepatocellular hypertrophy in the high dose male rats and in the female rats of the mid and high dose groups. The centrilobular areas were more prominent and the hepatocytes were larger with an increased amount of eosinophilic cytoplasm. Centrilobular hepatocellular hypertrophy was not observed in any of the satellite group rats.
OTHER FINDINGS
Two control female rats died prior to study termination. One rat had diffuse fibrinopurulent pleuropneumonia and pericarditis. These changes are believed to be related to a dosing accident with perforation of the esophagus in the thoracic cavity. The cause of death in the second control female included bacterial nephritis and an associated mucosal hyperplasia and distention of the ureter and urinary bladder.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related clinical in-life signs of toxicity and no mortality were observed at the highest dose tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Microscopic changes in the male kidneys characterized by hyaline droplet accumulation in the cytoplasm of the proximal tubules of the cortex and an increased incidence of multi-focal cortical tubular basophila with changes consistent with both degeneration and regeneration of the tubular epithelium and dilated medullary tubules with granular casts are typical of a syndrome that occurs specifically in male rats and is unlikely to have a correlation to humans. The syndrome, Alpha-2u-Globulin Nephropathy or Light Hydrocarbon Nephropathy is related to the accumulation of alpha-2u globulin in the lysosomes of the kidney.
Treatment-related microscopic change in the liver (centrilobular hepatocellular hypertrophy) of the mid-dose females and the high dose of both sexes in the absence of necrosis is typical of an adaptive change probably related to the livers' metabolism of large volumes of test material. This observation is supported by the increase in relative liver weights in these animals which is typical of an adaptive change.
Applicant's summary and conclusion
- Conclusions:
- Oral administration via gavage for 90 days produced no treatment-related clinical in-life signs of toxicity and no mortality at the highest dose tested. The no observable adverse effect level for MRD-90-868 is > 1000 mg/kg.
- Executive summary:
A 90-day subchronic study was conducted in rats to assess the toxicity of MRD-90-868. The test mixture was administered by oral gavage at a dose of 0, 100, 500, or 1000 mg/ kg 7 days per week for a period of 13 weeks. The control animals received a carrier (corn oil) dose and a satellite group was dosed at 1000 mg/ kg, 7 days/week for 13 weeks and was then observed for reversibility, persistence or delayed occurrence of toxic effects for 28 days post-treatment. Observations were made as to the nature, onset, severity, and duration of toxicological signs. There were no deaths attributed to the oral administration of MRD-90-868 (two control group females died prior to termination). The majority of animals in all groups displayed no observable abnormalities during the test period. The most frequently noted observations included broken/maloccluded incisors, alopecia, and scabs, all of which were considered incidental. Body weight, food consumption, and hematology data displayed no biologically significant trends for either males or females during the test period. The most remarkable finding was a treatment-related microscopic change in the liver of the mid-dose females and the high dose of both sexes. This change was minor and is typical of an adaptive change probably related to the livers metabolism of large volumes of test material and was reversible upon microscopic evaluation of the tissues from the satellite recovery group. Microscopic changes were also observed in the male kidneys at all doses. These changes are characteristic of kidney changes produced in male rats by hydrocarbons and are considered to be a male rat specific phenomenon without human significance. Based on the data recorded in this study, the NOAEL for MRD-90 -868 is >1000mg/kg.
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