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EC number: 922-153-0 | 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: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978/08/29-1980/01/25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-conducted study comparable to standard studies.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1978/08/29-1980/01/25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-conducted study comparable to standard studies.
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- 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):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No clinical signs attributable to exposure were observed. Five animals died during the study. 2 males and 1 female in the control group died during the exposure phase of the experiment, and 2 males in the medium exposure group died during the recovery phase. These deaths were not considered attributable to exposure to the test substance. 37 animals were removed from the study during both the exposure and recovery phase for various health reasons, most commonly sore hocks. The number of removals was similar for all exposure levels, including the control group and was not attributable to exposure to the test substance.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain was decreased the first 4 weeks in high exposure males, and medium exposure females. High exposure females had decreased body weight gains for the first 12 weeks of exposure, but recovered after exposure was terminated.
HAEMATOLOGY
Though some statistically significant changes were observed, particularly in males, no biologically significant changes were observed.
CLINICAL CHEMISTRY
Minor clinical chemical changes were observed at both the 26 and 12 month sacrifice, but were within normal ranges.
URINALYSIS
No differences between exposure and control groups were observed.
ORGAN WEIGHTS
Liver and kidney weights in the high dose males were significantly increased, but there were no histopathological lesions, so this was considered a functional hypertrophy of the organs.
HISTOPATHOLOGY: NON-NEOPLASTIC
No histopathological changes that could be attributable to exposure to the test substance were detected. - Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1 800 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Systemic Toxicity
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 900 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: reduced body weight
- Critical effects observed:
- not specified
- Conclusions:
- The NOAEC for male rats was determined to be 1800 mg/m3, the highest concentration tested. The NOAEC for female rats was determined to be 900 mg/m3, due to the reduced body weight noted.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C9 aromatics, based on analogue read across.
This study examined the effects of 12 months of inhalation exposure of rats to a commercial mixture of C9 Aromatics. Male and female rats were exposed to concentrations of 450, 900, or 1800 mg/m³ 6 hrs/day, 5 days/week, for up to 12 months. Some of the rats were sacrificed at 26 weeks, others at 12 months, and others after a 4 month recovery period after the end of the 12 month exposure. Animals were examined for clinical signs and behaviour twice daily, and weighed weekly for the first 4 weeks, and monthly thereafter. After sacrifice, the animals were examined for clinical chemistry, hematology, urine analysis, gross pathology, histopathology, and organ weights. No deaths attributable to exposure to the test substance occurred. There was depressed weight during the first few months of the experiment in medium (900 mg/m³) and high dose males (1800 mg/m³). However, the animals quickly recovered and this effect is not considered biologically significant. High dose females (1800 mg/m³) had depressed weight gain for the first 3 months of exposure, but recovered in subsequent months and in the satellite recovery group. No other adverse effects attributable to exposure to the test substance were seen. Based on the reversibility of the reduced weight gain and the lack of any noted pathology, the NOAEC for male rats was 1800 mg/m³ and the NOAEC for female rats was 900 mg/m3.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
- Reference Type:
- publication
- Title:
- Inhalation toxicity of high flash aromatic naphtha.
- Author:
- Clark DG, Butterworth ST, Martin JG, Roderick HR, Bird MG
- Year:
- 1 989
- Bibliographic source:
- Toxicol Ind Health. 1989 May;5(3):415-28.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- GLP compliance:
- no
- Remarks:
- prior to GLP
- Limit test:
- no
Test material
- Reference substance name:
- Solvent naptha (petroleum), light arom.
- IUPAC Name:
- Solvent naptha (petroleum), light arom.
- Reference substance name:
- Solvent naphtha (petroleum), light arom.
- EC Number:
- 265-199-0
- EC Name:
- Solvent naphtha (petroleum), light arom.
- Cas Number:
- 64742-95-6
- IUPAC Name:
- Solvent naphtha (petroleum), light arom.
- Reference substance name:
- Hydrocarbons, C9, aromatics
- EC Number:
- 918-668-5
- Molecular formula:
- None available - not a single isomer - see remarks.
- IUPAC Name:
- Hydrocarbons, C9, aromatics
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shell Toxicology Laboratory Breeding Unit
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 150-300 g
- Housing: Hanging aluminum cages with stainless steel mesh bases. Paper lined catch trays were beneath each layer of cages and cleaned daily. Animals were identified using an ear punch/notch system.
- Diet (e.g. ad libitum): PRD Labsure food was available ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 20
- Humidity (%): 50%
- Air changes (per hr): continuous airflow of 3-6 m³/min
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark
IN-LIFE DATES: 1978/08/29-1980/01/25
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 8 m³ stainless steel chamber.
- Method of holding animals in test chamber: cages
- Source and rate of air: air drawn from laboratory at 3-6m³/min
- Method of conditioning air: filters
- System of generating particulates/aerosols: Vapors were generated using quartz tubes with their surface temperature adjusted to 148°C, (high concentration), 130°C (medium concentration), 225°C (low concentration). The vapor entered the experiment chamber via micrometering pumps.
- Temperature, humidity, pressure in air chamber: 14-29.5°C, 35.5-73.5% humidity
- Air flow rate: 3-6m³/min
- Air change rate: continuous
TEST ATMOSPHERE
- Brief description of analytical method used: Test atmospheres were analyzed by a total hydrocarbon analyser for 10 min at intervals of 40 min during exposures. Test atmospheres were also analyzed continuously for 2 hrs during each exposure using gas chromatographs with a flame iionization detector.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Control: Nominal 0 mg/m^3, measured 0 mg/m³
Low: Nominal 450 mg/m^3, measured 470 +/- 29 mg/m³
Medium: Nominal 900 mg/m^3, measured 970 +/- 70 mg/m³
High: Nominal 1800 mg/m^3, measured 1830 +/- 130 mg/m³ - Duration of treatment / exposure:
- 12 months
- Frequency of treatment:
- 6 hrs per day, 5 days per week except for 8 public holidays, 2 snowdays, and exposure limited on 2 other days for unknown reasons
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 470 mg/m³, 970 mg/m³, 1830 mg/m³
Basis:
analytical conc.
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Rationale for animal assignment (if not random): Randomized block design with each control and experimental group in one block from the same litter.
- Post-exposure recovery period in satellite groups: 4 months - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: before start of experiment, weekly for first 4 weeks, monthly thereafter
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 10 animals of each sex from the high exposure and control groups had blood drawn at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, and 32 of exposure. Blood was also taken from 10 animals of each sex from each exposure level at the 26 and 52 week sacrfice, and from the 4 month recovery group.
- How many animals: 10 of each sex
- Parameters checked: Repeated sampling - erythrocyte count, mean cell volume, hemoglobin concentration, leucocyte count, mean corpuscular hemoglobin concentration, and hematocrit
Terminal sampling - erythrocyte count, mean cell volume, hemoglobin, leucocyte count, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, hematocrit, prothrombin time, kaolin-cephalin coagulation time, erythrocyte osmotic fragility. Reticulocytes were only counted in the high exposure and control groups at the 12 month sacrifice.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Blood taken from 10 animals of each sex from each exposure level at the 26 and 52 week sacrfice, and from the 4 month recovery group.
- Animals fasted: overnight
- How many animals: 10 of each sex
- Parameters checked: 12 month sacrifice - total protein, urea nitrogen, alkaline phosphatase, chloride ion, total bilirubin, total calcium, inorganic phosphate, uric acid, sodium, potassium, alanine amino transferase, aspartate amino transferase, glucose concentration, protein eleectrophoresis,
26 week sacrifice - protein, urea, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, chloride, sodium, potassium, portein electrophoresis
URINALYSIS: Yes
- Time schedule for collection of urine: male and females from each exposure group at 0, 3, 6, 9, and 12 months exposure, and 3 months after exposure.
- Parameters checked: Glucose, protein, ketones, bilirubin, blood pigments, pH, nitrite, urobilinogen - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Animals were sacrificed by injection of sodium pentobarbitone. All external surfaces, orifices, and the throacic and abdominal cavities were then examined. The following organs were then weighed: liver, kidneys, spleen, brain, heart, testes
HISTOPATHOLOGY: Yes
Histopathology was done on the following organs: salivary gland, stomach, heart, brain, spinal cord, pituitary gland, sciatic and posterier tibial nerves, lungs, prostate, seminal vesicles, testes, ovaries, uterus, skeletal muscle, adrenal glands, thyroids with esophagus and trachea, caecum, spleen, thymus, lymph node, mammary gland, small intestine, large intestine, pancreas, liver, kidneys, urinary bladder, eye and lachrymal glands, nasal cavity, spinal cord, tongue, knee joint and femur, any lesions - Statistics:
- Body and organ weights were analyzed by covariance analysis. Hematological and clinical parameters were examined using analysis of variance. Significance of any difference between treated and control goup means was tested using the Williams t test. If a monotonic dose response could not be assumed, Dunnett's test was used instead.
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):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No clinical signs attributable to exposure were observed. Five animals died during the study. 2 males and 1 female in the control group died during the exposure phase of the experiment, and 2 males in the medium exposure group died during the recovery phase. These deaths were not considered attributable to exposure to the test substance. 37 animals were removed from the study during both the exposure and recovery phase for various health reasons, most commonly sore hocks. The number of removals was similar for all exposure levels, including the control group and was not attributable to exposure to the test substance.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain was decreased the first 4 weeks in high exposure males, and medium exposure females. High exposure females had decreased body weight gains for the first 12 weeks of exposure, but recovered after exposure was terminated.
HAEMATOLOGY
Though some statistically significant changes were observed, particularly in males, no biologically significant changes were observed.
CLINICAL CHEMISTRY
Minor clinical chemical changes were observed at both the 26 and 12 month sacrifice, but were within normal ranges.
URINALYSIS
No differences between exposure and control groups were observed.
ORGAN WEIGHTS
Liver and kidney weights in the high dose males were significantly increased, but there were no histopathological lesions, so this was considered a functional hypertrophy of the organs.
HISTOPATHOLOGY: NON-NEOPLASTIC
No histopathological changes that could be attributable to exposure to the test substance were detected.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1 800 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Systemic Toxicity
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 900 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: reduced body weight
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEC for male rats was determined to be 1800 mg/m3, the highest concentration tested. The NOAEC for female rats was determined to be 900 mg/m3, due to the reduced body weight noted.
- Executive summary:
This study examined the effects of 12 months of inhalation exposure of rats to a commercial mixture of C9 Aromatics. Male and female rats were exposed to concentrations of 450, 900, or 1800 mg/m³ 6 hrs/day, 5 days/week, for up to 12 months. Some of the rats were sacrificed at 26 weeks, others at 12 months, and others after a 4 month recovery period after the end of the 12 month exposure. Animals were examined for clinical signs and behaviour twice daily, and weighed weekly for the first 4 weeks, and monthly thereafter. After sacrifice, the animals were examined for clinical chemistry, hematology, urine analysis, gross pathology, histopathology, and organ weights. No deaths attributable to exposure to the test substance occurred. There was depressed weight during the first few months of the experiment in medium (900 mg/m³) and high dose males (1800 mg/m³). However, the animals quickly recovered and this effect is not considered biologically significant. High dose females (1800 mg/m³) had depressed weight gain for the first 3 months of exposure, but recovered in subsequent months and in the satellite recovery group. No other adverse effects attributable to exposure to the test substance were seen. Based on the reversibility of the reduced weight gain and the lack of any noted pathology, the NOAEC for male rats was 1800 mg/m³ and the NOAEC for female rats was 900 mg/m3.
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