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EC number: 922-214-1 | CAS number: 1174921-63-1
- 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
Endpoint summary
Administrative data
Description of key information
Oral LD50 (Rat) > 5840 mg/kg bw
Inhalation LC50 (Rat) > 23000 mg/m3
Dermal LD50 (Rabbit) > 2200 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- standard acute oral test
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent
- Age at study initiation: approx. 12 weeks
- Fasting period before study: on night before test
- Housing: 4 animals of one sex in a cage
- Diet (e.g. ad libitum): ad libitum after dosing
- Water (e.g. ad libitum): ad libitum after dosing - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 1, 2, 4, and 8 mL/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 9 days
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 8 mL/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 8 mL/kg bw
- Mortality:
- No mortality occurred in any test animal over the 9-day observation period.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: other: EU, GHS, 2007
- Conclusions:
- The purpose of this study was to determine the acute oral toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Two male and two female rats were exposed to 1, 2, 4, or 8 mL/kg of undiluted test substance orally. The animals were then observed for the next 9 days for mortality. No animals of either sex died during the study. The LD50 is > 8 mL/kg for both male and female rats. Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw. The test substance is not classified according to OECD GHS guidelines.
- Executive summary:
The purpose of this study was to determine the acute oral toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Two male and two female rats were exposed to 1, 2, 4, or 8 mL/kg of undiluted test substance orally. The animals were then observed for the next 9 days for mortality. No animals of either sex died during the study. The LD50 is > 8 mL/kg for both male and female rats. Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw. The test substance is not classified according to OECD GHS guidelines.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July - September 1961
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Limited documentation.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Study was performed before actual guideline was established.
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 101 - 132 g
- Fasting period before study: Food was withheld from the animals for a period of 3 to 4 hours prior to dosage. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.1, 1.0 or 10 % volume/volume solution in corn oil (Mazola) - Doses:
- 31.6; 100; 316; 1000; 3160; and 10,000 µL/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (mortality and toxic effects): immediately after administration; at 1, 4 and 24 hours; and once daily thereafter for a total of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, pathology (brain, liver, kidney), blood levels were collected by exsanguination - Statistics:
- no data
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 mL/kg bw
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 7 100 - 7 800 mg/kg bw
- Remarks on result:
- other: recalculated values based on the LD50 of 10 mL/kg bw; the range is due to the range of density (0.71-0.78 g/cm3)
- Mortality:
- The test material produced no deaths at any dosage level tested.
- Gross pathology:
- There were no pathological findings in any animal at autopsy following sacrifice.
- Other findings:
- The animals at all dosage levels seemed normal in appearance and behaviour following intubation and daily during the 14 -day observation period.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: other: CLP
- Conclusions:
- Under the conditions of this study the test substance, hydrocarbons, C7-C9, isoalkanes, does not need to be classified.
- Executive summary:
Under the conditions of this study the test substance, C7-C9, isoalkanes, does not need not to be classified.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1961
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (limited documentation).
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Study was performed before actual guideline was established. Limited documentation.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 101 - 132 g
- Fasting period before study: Food was withheld from the animals for a period of 3 to 4 hours prior to dosage. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.1, 1.0 or 10 % volume/volume solution in corn oil (Mazola) - Doses:
- 31.6; 100; 316; 1000; 3160; and 10,000 µL/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (mortality and toxic effects): immediately after administration; at 1, 4 and 24 hours; and once daily thereafter for a total of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, pathology (brain, liver, kidney), blood levels were collected by exsanguination - Statistics:
- no data
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 mL/kg bw
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 7 100 - 7 800 mg/kg bw
- Remarks on result:
- other: recalculated values based on the LD50 of 10 mL/kg bw; the range is due to the range of density (0.71-0.78 g/cm3)
- Mortality:
- The test material produced no deaths at any dosage level tested.
- Gross pathology:
- There were no pathological findings in any animal at autopsy following sacrifice.
- Other findings:
- The animals at all dosage levels seemed normal in appearance and behaviour following intubation and daily during the 14 -day observation period.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: other: CLP
- Conclusions:
- Under the conditions of this study the test substance, hydrocarbons, C7-C9, isoalkanes, does not need to be classified.
- Executive summary:
Under the conditions of this study the test substance, hydrocarbons, C7-C9, isoalkanes, does not need to be classified.
Referenceopen allclose all
Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw
The acute oral LD50 of MRD-61-33 for male albino rats is therefore greater than 10 mL/kg bw corresponding to 7100 - 7800 mg/kg bw.
The acute oral LD50 of MRD-61-33 for male albino rats is therefore greater than 10 mL/kg body weight corresponding to 7100 - 7800 mg/kg bw.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 840 mg/kg bw
- Quality of whole database:
- Three key read across studies from structural analogues available for assessment.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 3 - 23 September 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Only single test concentration used.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd., Abbots Ripton Road, Wyton, Huntingdon
- Age at study initiation: 6 weeks (male), 8 weeks (female), different ages selected so that both sexes are of same body weight
- Weight at study initiation: 200 g
- Housing: polypropylene cages (38 x 56 x 18 cm) with wire meshes on tops and floors
- Diet (e.g. ad libitum): measured excess amount of food (Labsure LAD 1)
- Water (e.g. ad libitum): measured excess amount of tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): mean daily maximum: 25°C (SD 1.3), mean daily minimum: 21°C (SD 0.6)
- Humidity (%): mean relative humidity: 60% (SD 6.4) - 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: all parts were made of perspex
- Exposure chamber volume: 120 liters
- Method of holding animals in test chamber: Chamber divided by wire mesh partitions to provide 10 seperate animal compartments
- Source and rate of air: flow rate fo 25 L per minute; air warmed to 30°C to assist vaporisation of test substance. For the exposure a 50 mL syringe filled with the test substance was fitted to the syringe pump and connected to the atomiser with PTFE tubing. A flow rate of approx. 0.9 mL per minute was selected for the exposure. This flow rate was expected to give a concentration of vapour in excess of 20 mg/L of air. The syringe pump was switched on and the exposure timed for 4 hours, following an 11-minute equilibration period (total exposure time 4 hours 11 minutes). The syringe was refilled as required during the exposure.
- Method of conditioning air: The compressed air supply to the generator was dried, filtered and oil-free
- Temperature, humidity, pressure in air chamber: mean of 25.4°C in control and test
TEST ATMOSPHERE
- Brief description of analytical method used: 5 air samples were taken from the chamber during each exposure and analysed to determine the concentration of the test substance in the chamber atmosphere. The samples were drawn through a gas absorption trap, containing approximately 20 mL of acetone and cooled to -70°C in acetone/dry ice(=refrigerant). The sampling rate was 2 liters per minute and the volume of air sample was measured with a wet-type gas meter. One additional sample was taken using a Royco 218 particle size analyser to confirm the absence of droplets. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- GLC
- Duration of exposure:
- 4 h
- Concentrations:
- mean of 23.3 mg/L of air
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed continuously during exposure and at least twice daily during observation period. Weighed daily from the day of delivery to the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 23.3 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- One male died during exposure at approximately 2 hours from the start of exposure
- Clinical signs:
- other: Partial closing of the eyes, restless behaviour and a reduced respiration rate were the main clinical signs evident during exposure. The signs were considered to be consistent with exposure to a slightly irritant vapour. Other signs seen during exposure w
- Body weight:
- All rats exposed lost weight or had a reduced rate of bodyweight gain for 1-2 days following exposure. Subsequently the rate of bodyweight gain for exposed rats was similar to that of the control rats.
- Gross pathology:
- Findings for the rat that died following exposure were congestion of the lungs, yellow frothy fluid in the trachea and gas-filled stomach and gastro-intestinal tract
- Other findings:
- Food consumption was reduced for 1 day following exposure. Water consumption was not affected.
Histopathology: Marked pulmonary congestion and focal alveolar haemorrhage in the single deceased rat. Significance of this finding is uncertain. - Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: other: GHS, EU, 2007
- Conclusions:
- The purpose of the is study was to examine the inhalation toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rats. 5 male and 5 female rats were exposed to a concentration of 23.3 mg/L of test substance in the air for 4 hrs. Animals were examined at 0, 0.25, 0.5, 1, 2, 3, and 4 hrs after start of exposure for clinical signs and mortality. Animals were also examined daily for the next 14 days. Animals were weighed daily. Animals were examined for gross pathology and histopathology either after death, or after sacrifice at the end of the experiment. One male rat died during the experiment. The LC50 is > 23.3 mg/L of air. The test substance is not classified as toxic under the OECD GHS guidelines.
- Executive summary:
The purpose of the is study was to examine the inhalation toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rats. 5 male and 5 female rats were exposed to a concentration of 23.3 mg/L of test substance in the air for 4 hrs. Animals were examined at 0, 0.25, 0.5, 1, 2, 3, and 4 hrs after start of exposure for clinical signs and mortality. Animals were also examined daily for the next 14 days. Animals were weighed daily. Animals were examined for gross pathology and histopathology either after death, or after sacrifice at the end of the experiment. One male rat died during the experiment. The LC50 is > 23.3 mg/L of air. The test substance is not classified as toxic under the OECD GHS guidelines.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 01 August - 15 September 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- very limited documentation
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male (mean): 291 g, female (mean): 217.4 g - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: unchanged (no vehicle)
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- THC
- Duration of exposure:
- 4 h
- Concentrations:
- 24.88 mg/L (nominal)
99.5 ± 7.49 mg/L (re-calculated from 21300 ± 1604.23 ppm (mean measured) - No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 24.88 mg/L air (nominal)
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 24.88 mg/L air (nominal)
- Exp. duration:
- 4 h
- Mortality:
- none
- Clinical signs:
- other: After 15 min of exposure all animals displayed rapid breathing. At 30 min of exposure one male and all females showed tremors and hyperactivity. At one hour these animals became languid with tremors. All animals then were noted to be inactive with rapid r
- Body weight:
- mean body weight males: 302.2 g (Day 2 postexposure), 309.4 g (Day 3), 317.8 g (Day 4), 331.4 g (Day 7), 347 g (Day 14)
mean body weight females: 213.6 g (Day 2 postexposure), 215.6 g (Day 3), 221.4 g (Day 4), 227.4 g (Day 7), 232.8 g (Day 14) - Gross pathology:
- All animals appeared normal at the terminal sacrifice with the exception of one male noted to have a small left testis and one male observed to have a dilated right renal pelvis filled with clear fluid.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: other: GHS, EU, 2007
- Conclusions:
- According to the study design N-octane can be considered to be non-toxic.
- Executive summary:
According to the study design N-octane can be considered to be non-toxic.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Limited documentation.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (males: Lakeview Facility, Lakeview, New Jersey; females: Kingston Facility, Stone Ridge, New York)
- Age at study initiation: probe study: 8-9 weeks
- Weight at study initiation: 237-363 g
- Housing: individually housed during and after exposure; stainless steel wire mesh
- Diet: non-certified, pelleted, rat and mouse ration (NIH-07), Zeigler Bros., Inc., Gardners, PA, USA; not contaminated; ad libitum during non-exposure periods
- Water: automatic watering system (Elizabethtown Water Company, NJ, USA); not contaminated; ad libitium during non-exposure periods
- Acclimation period: 22 days; paired by sex for one week, then individiually thereafter
- Other: Random allocation to groups via computer-generated random numbers, with assignment to groups so as to nearly equalise by sex the initial mean group body weights.
Animals were identified by ear tags and corresponding cage identification.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22.2 °C (68-72 degree Fahrenheit)
- Humidity (%): 33-67 %
- Photoperiod (hrs dark / hrs light): 12/12 - 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: glass inhalation chamber
- Exposure chamber volume: approximately 1000 L
- Method of holding animals in test chamber: individually housed
- Source and rate of air: 200 L per minute; equivalent to 12 air changes
- Temperature, humidity: 21.1-27.8°C (70-82 °Fahrenheit); 31-42 %
Dual generators were needed to volatilise the test material. The test material was pumped (Fluid Metering, Inc.) at a fixed rate into the top of each generator, so that it would run down along the internal spiral shelf of the generator. As it ran down in contact with the heated surface, the test material volatilised, and was swept into the dosing chamber by the chamber airflow. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Actual exposure concentrations were determined by spectrophotometry (Miran 1A Ambient Air Analyser).
- Duration of exposure:
- 4 h
- Concentrations:
- 21.25 mg/L nominal
21.00 mg/L actual - No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Detailed individual observations were performed again upon removal from the chamber following exposure, and once daily for 14 days post-exposure.
- Necropsy of survivors performed: yes - A gross necropsy was performed on each animal by a qualified prosector.
- Other examinations performed: Lungs (with trachea), liver, kidneys, and whole head were collected and preserved in 10 % neutral-buffered formalin (lungs perfused by a constant pressure device) for possible future histopathological evaluation. - Statistics:
- Means and standard deviations of relevant animal and exposure data were calculated. In addition, group mean body weights were compared statistically by group and sex. A computerised statistical evaluation for equality of means (2 groups) was performed, using a 2 sample t-test. The computer performed a standard F-test to determine if the 2 groups had equal variance. If the variances were equal, testing was be based on the standard t-test. If the variances were not equal, the Smith-Satterthwaite Correction for unequal variances was used. The F-test for equal variances was conducted at the 1% level of significance. The t-test were conducted at the 5% and 1% level of significance.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 21 mg/L air (analytical)
- Exp. duration:
- 4 h
- Remarks on result:
- other: 21 mg/L correspond to 4504 ppm.
- Mortality:
- no mortality
- Clinical signs:
- other: During exposure (after 2 of 4 hours), the dosed animals showed signs for irritation (eye, nose and throat). Dosed animals also appeared to be more alert than control animals after 2 hours of dosing. After exposure 3 of 12 rats had dried red nasal discharg
- Body weight:
- Mean animal body weights for all males and females were unremarkable at all weighing intervals.
- Gross pathology:
- There were 7 control rats and 8 dosed rats without abnormalities at necropsy. Of the remainder, there was a greater incidence of focal lung discoloration in the controls than in the dosed rats, a comparable incidence of dilated renal pelvis, and one instance of a dosed rat having a broken upper incisor. None of these observations was considered to be related to treatment with the test substance.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Only 6 males tested per dose level, limited documentation on environmental conditions.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- Study was performed before actual guideline was established.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: mean weight range: 254 - 397 g
- Fasting period before study: no
- Housing: in groups
- Diet (e.g. ad libitum): ad libitum during pre-and postexposure period
- Water (e.g. ad libitum): ad libitum during pre-and postexposure period
- Acclimation period: yes, duration not reported - 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: dynamic exposure chamber
- Exposure chamber volume: 20 liter
- Method of holding animals in test chamber: none
- System of generating particulates/aerosols: The compound was mixed with air and metered: room air was passed through the heated test substance in a fritted-disc glass gas washing bottle. Different chamber concentrations were obtained by: 1) dilution of the saturated main air stream with make-up air in varying ratios, or 2) elevating the generation temperature and thus increasing the vapour pressure to provide a supersaturated vapour. The test material vapour was generated at 75°F (23.9°C).
- Method of particle size determination: not applicable
TEST ATMOSPHERE
- Brief description of analytical method used: 1) Determination of the ratio of the net loss of material to the total air flow volume for the period of exposure; 2) Sampling with a Model 40 M.S.A. Combustible Gas Meter standardized against pentane. The latter method required the use of a correction for each reading due to a Lower Explosive Limit of 1.4 for pentane and of 1.0 for the test compound.
- Samples taken from breathing zone: no
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not applicable, vapour - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Sampling with a Model 40 M.S.A. Combustible Gas Meter standardized against pentane
- Duration of exposure:
- 4 h
- Concentrations:
- 1850, 3100, 5750, 10000 ppm
- No. of animals per sex per dose:
- 6 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology (not performed, but sections of lungs, liver, spleen, kidneys, adrenals and testes were prepared for possible future analysis) - Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 4 240 ppm
- Exp. duration:
- 4 h
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 17.3 - 22.2 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: Recalculated values based on the LC50 of 4240 ppm; the range of LC50 is due to unknown amounts of hydrocarbons in the test substance with chain lengths ranging from C7 to C9.
- Mortality:
- 1850 ppm: 0/6
3100 ppm: 0/6
5750 ppm: 6/6
> 10000 ppm: 6/6 - Clinical signs:
- other: Exposure to lethal concentrations induced a rapid and dramatic response. Repeated episodes of violent epileptiform convulsions, interspersed with periods of running and jumping. If the animal succumbed, it was always in a position with all four legs fully
- Gross pathology:
- The lungs of animals which died during exposure showed hemorrhagic areas with gray spots on the surfaces. Severe lung congestion was an isolated finding and lung consolidation was seen infrequently. In general, the livers and kidneys were congested in these animals, but all other organs appeared normal. Animals surviving the 14-day observation period revealed little of interest at autopsy. In a few instances, hemorrhagic areas were noted on the lung surfaces and an occasionally darkened liver or kidney was seen. All other organs appeared normal.
- Interpretation of results:
- other: Harmful
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The LC50 value was calculated to be 4240 ppm, corresponding to 17300 -22200 mg/m³ (recalculated values based on the LC50 of 4240 ppm). The range of LC50 is due to unknown amounts of hydrocarbons in the test substance with chain lengths ranging from C7 to C9.
Due to the unknown composition of the test substance of hydrocarbons of varying chain length (C7-C9), there is the possibility of a recalculated LC50 below 20 mg/L. Therefore, the test substance should be classified as harmful if inhaled (Category 4) according to the criteria of the CLP. - Executive summary:
The LC50value was calculated to be 4240 ppm, corresponding to 17300 -22200 mg/m³ (recalculated values based on the LC50 of 4240 ppm). The range of LC50 is due to unknown amounts of hydrocarbons in the test substance with chain lengths ranging from C7 to C9.
Due to the unknown composition of the test substance of hydrocarbons of varying chain length (C7-C9), there is the possibility of a recalculated LC50 below 20 mg/L. Therefore, the test substance should be classified as harmful if inhaled (Category 4) according to the criteria of the CLP.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Only 6 males tested per dose level, limited documentation on environmental conditions.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- Study was performed before actual guideline was established.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: mean weight range: 272 - 318 g
- Fasting period before study: no
- Housing: in groups
- Diet (e.g. ad libitum): ad libitum during pre-and postexposure period
- Water (e.g. ad libitum): ad libitum during pre-and postexposure period
- Acclimation period: yes, duration not reported - 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: dynamic exposure chamber
- Exposure chamber volume: 20 liter
- Method of holding animals in test chamber: none
- System of generating particulates/aerosols: The compound was mixed with air and metered: room air was passed through the heated test substance in a fritted-disc glass gas washing bottle. Different chamber concentrations were obtained by: 1) dilution of the saturated main air stream with make-up air in varying ratios, or 2) elevating the generation temperature and thus increasing the vapour pressure to provide a supersaturated vapour. The test material vapour was generated at 75°F (23.9°C).
- Method of particle size determination: not applicable
TEST ATMOSPHERE
- Brief description of analytical method used: 1) Determination of the ratio of the net loss of material to the total air flow volume for the period of exposure; 2) Sampling with a Model 40 M.S.A. Combustible Gas Meter standardized against pentane. The latter method required the use of a correction for each reading due to a Lower Explosive Limit of 1.4 for pentane and of 1.0 for the test compound.
- Samples taken from breathing zone: no
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not applicable, vapour - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Sampling with a Model 40 M.S.A. Combustible Gas Meter standardized against pentane
- Duration of exposure:
- 4 h
- Concentrations:
- 1050, 2390, 4450, 7140 ppm
- No. of animals per sex per dose:
- 6 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (histopathology was not performed, but sections of lungs, liver, spleen, kidneys, adrenals and testes were prepared for possible future analysis) - Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 4 450 ppm
- Exp. duration:
- 4 h
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 18.2 - 23.3 mg/L air (analytical)
- Exp. duration:
- 4 h
- Remarks on result:
- other: Recalculated values based on the LC50 of 4450 ppm; the range of LC50 is due to unknown amounts of hydrocarbons in the test substance with chain lengths ranging from C7 to C9.
- Mortality:
- 1050 ppm: 0/6
2390 ppm: 0/6
4450 ppm: 3/6
> 7140 ppm: 6/6 - Clinical signs:
- other: Animals exposed to lethal concentrations exhibited clonic convulsions, laboured respiration, ataxia, and prostration preterminally. At the highest concentration, all six rats died within 1 hour; animals which survived 4 hours of exposure to 4450 ppm had a
- Gross pathology:
- The lungs of animals which died during exposure showed hemorrhagic areas with gray spots on the surfaces. Severe lung congestion was an isolated finding and lung consolidation was seen infrequently. In general, the livers and kidneys were congested in these animals, but all other organs appeared normal. Animals surviving the 14-day observation period revealed little of interest at autopsy. In a few instances, hemorrhagic areas were noted on the lung surfaces and an occasionally darkened liver or kidney was seen. All other organs appeared normal.
- Interpretation of results:
- other: Harmful
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The LC50 value was calculated to be 4450 ppm, corresponding to 18200 -23300 mg/m³ (recalculated values based on the LC50 of 4450 ppm). The range of LC50 is due to unknown amounts of hydrocarbons in the test substance with chain lengths ranging from C7 to C9.
Due to the unknown composition of the test substance of hydrocarbons of varying chain length (C7-C9), there is the possibility of a recalculated LC50 below 20 mg/L. Therefore, the test substance should be classified as harmful if inhaled (Category 4) according to the criteria of the CLP. - Executive summary:
The LC50value was calculated to be 4450 ppm, corresponding to 18200 -23300 mg/m³ (recalculated values based on the LC50 of 4450 ppm). The range of LC50 is due to unknown amounts of hydrocarbons in the test substance with chain lengths ranging from C7 to C9.
Due to the unknown composition of the test substance of hydrocarbons of varying chain length (C7-C9), there is the possibility of a recalculated LC50 below 20 mg/L. Therefore, the test substance should be classified as harmful if inhaled (Category 4) according to the criteria of the CLP.
Referenceopen allclose all
Table: Mean Bodyweights (g)
Day |
Female Control |
Female Test |
Male Control |
Male Test |
-5 |
174 |
179 |
153 |
148 |
-4 |
183 |
186 |
164 |
164 |
-3 |
189 |
185 |
172 |
176 |
-2 |
194 |
191 |
187 |
194 |
-1 |
198 |
197 |
196 |
201 |
0 |
203 |
202 |
203 |
211 |
1 |
203 |
199 |
211 |
212 |
2 |
205 |
201 |
222 |
219 |
3 |
213 |
211 |
229 |
232 |
4 |
214 |
212 |
237 |
242 |
5 |
216 |
209 |
240 |
249 |
6 |
219 |
211 |
248 |
255 |
7 |
221 |
212 |
259 |
264 |
8 |
228 |
215 |
273 |
282 |
9 |
230 |
226 |
276 |
285 |
10 |
234 |
227 |
285 |
295 |
11 |
242 |
234 |
297 |
307 |
12 |
242 |
238 |
300 |
315 |
13 |
244 |
238 |
303 |
319 |
14 |
246 |
239 |
308 |
324 |
Vapour concentrations in the air in the range of 0.5 to 1.0 % are easily produced by the volatilization of the test substance at room temperature.
Vapour concentrations in the air of the order of 0.5 to 1.0 % are easily produced by the volatilization of the test substance at room temperature.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 23 300 mg/m³ air
- Physical form:
- inhalation: vapour
- Quality of whole database:
- Two key, three weight of evidence, and four supporting read across toxicity studies from structural analogues available for assessment.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- The acute toxicity of SBP 100/140 was determined according to Noakes and Sanderson (1969): A method for determining the dermal toxicity of pesticides, Br. J. Industr Med 26: 59-64.
- GLP compliance:
- no
- Test type:
- other: according to Noakes and Sanderson (1969), Br. J. Industr Med 26: 59-64
- Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent - Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 1, 2, 4 mL/kg
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 4 mL/kg bw
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 800 - 3 100 mg/kg bw
- Remarks on result:
- other: Recalculated values based on the LD50 of 3.16 mL/kg bw; the range of LD50 is due to the range of density 0.71 -0.78 g/cm3.
- Mortality:
- none
- Clinical signs:
- other: none
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: other: CLP
- Conclusions:
- The dermal toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics was examined. Groups of two female and two male rats were exposed dermally to 1, 2, or 4 mL/kg of test substance. No animals died during the experiment. The dermal LD50 for rats is >= 4 mL/kg. The test substance is not classified as a dermal toxic under OECD GHS guidelines.
- Executive summary:
The dermal toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics was examined. Groups of two female and two male rats were exposed dermally to 1, 2, or 4 mL/kg of test substance. No animals died during the experiment. The dermal LD50 for rats is >= 4 mL/kg. The test substance is not classified as a dermal toxic under OECD GHS guidelines.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July - September 1961
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- Standard acute method, applying 4 different doses to the clipped, intact abdominal skin
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.4 - 2.3 kg
- Housing: Throughout the observation period, the rabbits were housed individually in metal cages elevated above the droppings. Purina Rabbit Pellets and water were freely available at all times. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: abdominal skin
- Type of wrap if used: dental daming binder; wrapped with gauze and adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with sponge and warm water
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 100, 316, 1000, 3160 µL/kg bw
- No. of animals per sex per dose:
- 4
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days (daily)
- Frequency of observations and weighing: 0, 1, 4, 24 hours
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3.16 mL/kg bw
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 200 - 2 500 mg/kg bw
- Remarks on result:
- other: Recalculated values based on the LD50 of 3.16 mL/kg bw; the range of LD50 is due to the range of density 0.71 -0.78 g/cm3.
- Mortality:
- No deaths at any dosage level.
- Clinical signs:
- other: Apart from 3 rabbits (2 of the 100 µL/kg dose group and one of the 3160 µL/kg dose group) which showed diarrhea for 2 to 4 days during the observation period, all animals seemed normal in appearance and behaviour throughout the study.
- Gross pathology:
- At autopsy, the 3 rabbits which showed diarrhea for 2 to 4 days during the observation period, exhibited pathological findings. One animals of the 100 µL/kg dose group showed paleness of the cortical portion of the kidneys. The other animals from the 100 µL/kg dose group showed an excessive amount of clear fluid in the peritoneal cavity and congested, pitted, tough kidneys. The rabbit of the high dose group showed inflammation of the intestines.
- Other findings:
- Dermal effects: Following removal of the binders at the end of the exposure period, the abdomens and binders were dry. At this time, the exposed skin areas of the animals showed a slight degree of erythema. Within an additional one to three days, the erythema had completely subsided in all animals. The low level animals showed no other signs of irritation during the reminder of the observation period. The high level animals showed slight or moderate desquamation during the final few days of the first week and during most of the second week. At termination, however, the exposed skin of the surviving animals was completely free of signs of irritation.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: other: CLP
- Conclusions:
- There is no need for classification.
- Executive summary:
There is no need for classification.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July - September 1961
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- Standard acute method, applying 4 different doses to the clipped, intact abdominal skin
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.4 - 2.3 kg
- Housing: Throughout the observation period, the rabbits were housed individually in metal cages elevated above the droppings. Purina Rabbit Pellets and water were freely available at all times. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: abdominal skin
- Type of wrap if used: dental daming binder; wrapped with gauze and adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with sponge and warm water
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 100, 316, 1000, 3160 µL/kg bw
- No. of animals per sex per dose:
- 4
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days (daily)
- Frequency of observations and weighing: 0, 1, 4, 24 hours
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3.16 mL/kg bw
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 200 - 2 500 mg/kg bw
- Remarks on result:
- other: Recalculated values based on the LD50 of 3.16 mL/kg bw; the range of LD50 is due to the range of density 0.71 -0.78 g/cm3.
- Mortality:
- There were three deaths, one at each at the 100, 1000, and 3160 µL/kg bw levels. These deaths were apparently the result of a severe intestinal infection. Blood samples were collected by cardiac puncture. All samples were frozen
- Clinical signs:
- other: 100 µL/kg dose: 2 animals normal in appearance and behaviour; One animal normal until 11th day, at which time this animal showed diarrhea and on day 14 depression, labored respiration, diarrhea 316 µL/kg dose: all animals showed normal behaviour 1000 µL/k
- Gross pathology:
- 100 µL/kg dose: congestion of the kidneys, inflammation of the samll intestine, and a large amount of fluid in the gastrointestinal tract was found in one animal sacrificed
316 µL/kg dose: no pathology observed
1000 µL/kg dose: no pathology observed
3160 µL/kg dose: firm, elevated, blanched areas on the gallbladder, and extensive amount of fluid in the peritoneal cavity, and inflammation of the intestines - Other findings:
- Dermal effects: Following removal of the binders at the end of the exposure period, the abdomens and binders were dry. At this time, the exposed skin areas of the animals showed a slight degree of erythema. Within an additional one to three days, the erythema had completely subsided in all animals. The low level animals showed no other signs of irritation during the reminder of the observation period. The high level animals showed slight or moderate desquamation during the final few days of the first week and during the second week. At termination, however, the exposed skin of the surviving animals was completely free of signs of irritation.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: other: CLP
- Conclusions:
- There is no need for classification.
- Executive summary:
There is no need for classification.
Referenceopen allclose all
Table: Mortality
Dose ml/kg |
Males |
Female |
Total |
1 |
0/2 |
0/2 |
0/4 |
2 |
0/2 |
0/2 |
0/4 |
4 |
0/2 |
0/2 |
0/4 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Threekey read across studies from structural analogues available for assessment.
Additional information
There is no acute toxicity data for Hydrocarbons, C7-C8, n-alkanes. However, acute toxicity data is available for structural analogues Hydrocarbons, C7-C9, isoalkanes, Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics, and Octane and presented in the dossier. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.
Oral
Hydrocarbons, C7-C9, n-alkanes, isoakanes, cyclics
The acute oral toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics was tested following a standard method (Shell Chemicals, 1977). Two male and two female rats were exposed to 1, 2, 4, or 8 mL/kg of undiluted test substance orally by gavage. The animals were then observed for the next 9 days for mortality. No animals of either sex died during the study. The LD50 was > 8 mL/kg for both male and female rats. Based on the density given in the study report, the LD50 was calculated to be higher than approx. 5840 mg/kg bw.
Hydrocarbons, C7-C9, isoalkanes
The acute oral LD50 value in rats was greater than 10 mL/kg for hydrocarbons, C7-C9, isoalkanes in two studies performed according to a protocol similar to OECD 401. The test material produced no deaths at any dosage level tested (31.6-10000 µL/kg body weight). There were no pathological findings in any animal at autopsy following sacrifice. The animals at all dosage levels seemed normal in appearance and behaviour throughout the study period (ExxonMobil Chemical, 1961a,b).
Inhalation
Hydrocarbons, C7-C9, n-alkanes, isoakanes, cyclics
Wistar rats (5/sex) were exposed via inhalation (whole body) to hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics at 23300 mg/m³ for 4 h (similar to OECD 403). Clinical signs during exposure included signs of slight irritation, partial closing of the eyes, lacrimation, a reduced respiration rate and restless behaviour. One male rat died during the exposure. The signs recorded during the observation period were hyperactivity and abnormal breathing. Reduced body weight for 1-2 days and reduced food consumption for 1 day following exposure. The lung weight for the decedent rat was high, but within normal limits for the others. The LC50 was greater than 23300 mg/m³ (Shell Chemicals, 1988).
In another study, male and female Charles River CD rats (2/sex/concentration) were exposed via whole body inhalation to hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics at 11000, 29000, 33000, 42000, or 49000 mg/m³ for four hours (similar to OECD 403). Clinical signs included mild piloerection, restlessness and tremors of the fore-paws. None of 4 rats died at 33000 mg/m³, 3 of 4 rats died at 42000 mg/m³ and 7/8 rats died at 49000 mg/m³. Before death the rats lapsed into a comatose state, and one animal showed excess salivation and had a blood-stained nasal discharge. Surviving animals exhibited mild excitability on removal from the chamber and slight ataxia was observed, however, this effect disappeared within 1 h after the end of exposure. The animals surviving the exposure also survived the subsequent 14 day observation period. The LC50 was 33000 - 42000 mg/m³ (Shell Chemicals, 1977).
Male Wistar rats (10/concentration) were exposed in a further study via whole body inhalation to Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics at 4400, 9800 or 26000 mg/m³ for four hours (similar to OECD 403). Mortality was 100% at 26000 mg/m³; no deaths at 9800 or 4400 mg/m³. Clinical signs in rats at higher concentrations included eye irritation and central nervous system depression (poor coordination with convulsions preceding death). Rats exposed to 4400 mg/m³ did not exhibit physical signs during or after exposure or during 14 days of observation. Gross necropsy observations of rats that died after 26000 mg/m³ Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics were congestion of lung and liver. Bile duct proliferation and increased number of leukocytes in sinusoids of the spleen were noted in 3 of 6 livers examined histologically Rats killed 14 days after inhaling 9800 or 4400 mg/m³ for 4 hrs evidenced singly occurring bronchitic effects and extraneous lesions in organs other than the lung. The LC50 was 16000 mg/m³ (Carpenter et al., 1975).
Octane
In a key study (Chevron Phillips Chemicals, 1983), five male and five female rats were administered a single 24.88 mg/L (24880 mg/m3) dose of Octane via inhalation for 4 hours. Animals were observed for mortality and clinical signs during exposure and for the next 14 days. No animals died during the study. Clinical signs observed during exposure included rapid breathing, tremors and inactivity. No treatment-related abnormalities were observed at necropsy. The LC50 was determined to be > 24.88 mg/L (24880 mg/m3). Under the conditions of this study, Octane does not need to be classified.
Hydrocarbons, C7-C9, isoalkanes
In one study, 6 rats (male and female) were exposed to a nominal concentration of 21500 mg/m³ (21000 mg/m³ actual concentration) in a whole body chamber for 4 h. Another group of 6 animals was sham-exposed to room air and served as control. No mortalities occurred throughout the duration of the study (14 days). After exposure 3 of 12 rats had dried red nasal discharge, 1 of 12 rats had slight salivation, and 1 of 12 rats had slight lacrimation. All abnormal signs in the dosed animals were cleared by day 2 post-exposure. One control rat exhibited dried red nasal discharge on days 10 and 11 post-exposure, but this sign was considered inconsequential to the study outcome. There were 7 control rats and 8 dosed rats without abnormalities at necropsy. Of the remainder, there was a greater incidence of focal lung discoloration in the controls than in the dosed rats, a comparable incidence of dilated renal pelvis, and one instance of a dosed rat having a broken upper incisor. None of theses observations was considered to be related to treatment with the test substance. The LC50was greater than 21000 mg/m³, corresponding to 4504 ppm (ExxonMobil Chemical, 1985).
In two earlier studies, rats (6 males) were exposed for 4 h to 1850, 3100, 5750 and 10000 ppm and 1050, 2390, 4450 and 7140 ppm, respectively. In the first study, mortalities occurred at 5750 ppm (6/6) and higher. Exposure to lethal concentrations induced a rapid and dramatic response. Repeated episodes of violent epileptiform convulsions, interspersed with periods of running and jumping. Death occurred within 17 minutes for all rats tested at the highest concentration. The lungs of animals which died during exposure showed haemorrhagic areas with gray spots on the surfaces. Severe lung congestion was an isolated finding and lung consolidation was seen infrequently. In general, the livers and kidneys were congested in these animals, but all other organs appeared normal. Animals surviving the 14-day observation period revealed little of interest at autopsy. In a few instances, haemorrhagic areas were noted on the lung surfaces and an occasionally darkened liver or kidney was seen. All other organs appeared normal. The LC50 value was calculated to be 4240 ppm, corresponding to 17300 -22200 mg/m³. The range of LC50 is due to unknown amounts of hydrocarbons in the test substance with chain lengths ranging from C7 to C9 (ExxonMobil Chemical, 1962).
In the second study, 3/6 and 6/6 animals died at 4450 and 7140 ppm, respectively. Animals exposed to lethal concentrations exhibited clonic convulsions, laboured respiration, ataxia, and prostration preterminally. At the highest concentration, all six rats died within 1 hour; animals which survived 4 hours of exposure to 4450 ppm had a bloody exudate around the eyes and nose at the end of the exposure period. The lungs of animals which died during exposure showed haemorrhagic areas with gray spots on the surfaces. Severe lung congestion was an isolated finding and lung consolidation was seen infrequently. In general, the livers and kidneys were congested in these animals, but all other organs appeared normal. Animals surviving the 14-day observation period revealed little of interest at autopsy. In a few instances, haemorrhagic areas were noted on the lung surfaces and an occasionally darkened liver or kidney was seen. All other organs appeared normal. The LC50 value was 4450 ppm, corresponding to 18200 -23300 mg/m³. As mentioned above, the range of LC50 is due to unknown amounts of hydrocarbons in the test substance with chain lengths ranging from C7 to C9 (ExxonMobil Chemical, 1962).
Two further studies were performed on guinea pigs and rats following non-guideline procedures. In each study, 5 animals were exposed to 9400 mg/m³ for 10 min every 30 min during 4 h, yielding a total of eight 10-min exposures. In both studies, none of the guinea pigs or rats exposed died during the exposures or during the 14-day observation period which followed. No pathological, histopathological or behavioural effects were observed throughout the study. The LC50 value in both guinea pigs and rats was greater than 9400 mg/m³ (ExxonMobil Chemical, 1972).
Dermal
Hydrocarbons, C7-C9, n-alkanes, isoakanes, cyclics
The substance hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics was applied on the shaved backs of Charles River CD rats (2/sex/dose) at 1, 2, and 4 mL/kg bw (730, 1460, and 2920 mg/kg bw) for 24 hours in accordance with the method of Noakes and Sanderson, 1969 [Br. J Indust. Med 26:59-64] (similar to OECD 402). No deaths or clinical signs were observed. The LD50 was greater than 4 mL/kg bw, corresponding to 2920 mg/kg bw (Shell Chemicals, 1977).
Hydrocarbons, C7-C9, isoalkanes
Two studies were performed in which hydrocarbons, C7-C9, isoalkanes, were applied to the clipped, intact abdominal skin of albino rabbits (4/sex/dose) at 100, 316, 1000, 3160 µL/kg bw for 24 h under occlusive conditions. In the first study, there were three deaths, one each at the 100, 1000, and 3160 µL/kg bw levels. These deaths were apparently the result of a severe intestinal infection. In the 100 µL/kg group one animal showed diarrhoea on day 11 and on day 14 depression, laboured respiration and diarrhoea. In the same group, congestion of the kidneys, inflammation of the small intestine, and a large amount of fluid in the gastrointestinal tract was found in one animal at necropsy. At the 3160 µL/kg level, firm, elevated, blanched areas on the gallbladder, and extensive amount of fluid in the peritoneal cavity, and inflammation of the intestines were observed.
In the second study, no deaths at any dosage level occurred. Apart from 3 rabbits all other animals showed normal behaviour and appearance throughout the study. Two rabbits from the lowest dose treatment showed diarrhoea for two to four days and a decrease in body weight. At autopsy one showed paleness of the cortical portion of the kidneys, the other an excessive amount of clear fluid in the peritoneal cavity and congested, pitted, tough kidneys. One rabbit of the high dose group showed inflammation of the intestines.
In both studies the following dermal effects were noted: After removal of the binders at the end of the exposure period, the abdomens and binders were dry. At this time, the exposed skin areas of the animals showed a slight degree of erythema. Within an additional one to three days, the erythema had completely subsided in all animals. The low dose animals showed no other signs of irritation during the remainder of the observation period. The high dose animals showed slight or moderate desquamation during the final few days of the first week and during the second week. At termination, however, the exposed skin of the surviving animals was completely free of signs of irritation.
The LD50 value was greater than 3.16 mL/kg bw in both studies (ExxonMobil Chemical, 1961c,d).
Justification for classification or non-classification
Based on available read across data, Hydrocarbons, C7-C8, n-alkanes is minimally toxic via ingestion where the LD50 is >5840 mg/kg bw, via dermal exposure where the LD50 is >2200 mg/kg bw, and by inhalation where the LC50 is > 23300 mg/m3. These findings do not warrant classification under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Hydrocarbons, C7-C8, n-alkanes is classified under EU CLP guidelines as STOT Single Exposure Category 3 (narcosis) based on non-lethal narcotic effects observed in acute inhalation exposure.
Hydrocarbons, C7-C8, n-alkanes is classified under EU CLP guidelines as a Category 1 aspiration hazard based on its physical and chemical properties (hydrocarbon fluid, viscosity ≤ 20.5 mm2/s).
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