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Diss Factsheets
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EC number: 946-365-8 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- 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: Source of data is from peer reviewed literature. Acceptable well-documented study report which meets basic scientific principles: non-GLP.
- Justification for type of information:
- Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- sub-chronic toxicity: inhalation
- 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: Source of data is from peer reviewed literature. Acceptable well-documented study report which meets basic scientific principles: non-GLP.
- Justification for type of information:
- Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
- 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:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- RATS. One rat at the 0.10-mg/liter level died after 14 days. Death was attributed to a pneumonic infection as evidenced by extensive lung abscesses. None of the observations were dosage-related and are discounted for that reason.
Significant findings (Rats) - Concentration (mg/liter)
Specific gravity urine, 9 weeks, rats - 0.38 mg/liter - Not dosage-related;
Blood urea nitrogen, 3 weeks, rats 0.10 mg/liter - Not dosage related;
Red blood cell count, Packed cell volume, and Hemoglobin, 9 weeks, rats 0.38 mg/liter - Not dosage-related
Alkaline phosphatase, 9 weeks, rats 0.10 mg/liter - Not dosage-related;
Neutrophil differential, 13 weeks, rats 0.22 mg/liter - Not dosage-related;
Lymphocyte differential, 13 weeks, rats 0.22 mg/liter - Not dosage-related.
DOGS. Pre-exposure polymorphonuclear neutrophilic leucocytes for the 0.1 mg/liter dogs were slightly higher than the controls on an absolute basis, but on the basis of change from pre-exposure after 13 weeks of inhalation, there were no significant differences that were treatment related. - Key result
- Dose descriptor:
- NOAEC
- Remarks:
- Rat
- Effect level:
- > 0.38 mg/L air (analytical)
- Sex:
- male/female
- Basis for effect level:
- other: Systemic Toxicity
- Key result
- Dose descriptor:
- NOAEC
- Remarks:
- Dog
- Effect level:
- > 0.38 mg/L air (analytical)
- Sex:
- male
- Basis for effect level:
- other: Systemic Toxicity
- Key result
- Critical effects observed:
- no
- Conclusions:
- The test material’s NOAEC > 0.38 mg/liter (66 ppm), which was the highest achievable vapor concentration.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C10 aromatics based on analogue read across.
Twenty-five male rats and four dogs per level were exposed for 6 hr/day, 5 days/wk for 13 wk. Another 20 rats, from the same week of production, were maintained for use as challenge exposure controls (naive rats). The challenge exposures were run to determine whether the 6-hr daily inhalation of a non-lethal level of hydrocarbon, would result in the rat becoming more or less resistant.
One rat at the 0.10-mg/liter level died after 14 days. Death was attributed to a pneumonic infection as evidenced by extensive lung abscesses. None of the observations were dosage-related and are discounted for that reason. The test material’s NOAEC > 0.38 mg/liter (66 ppm), which was the highest achievable vapor concentration.
Data source
Reference
- Reference Type:
- publication
- Title:
- Petroleum hydrocarbon toxicity studies XIV. Animal and human response to vapors of "high aromatic solvent".
- Author:
- Carpenter CP, Geary DL Jr, Myers RC, Nachreiner DJ, Sullivan LJ, King JM.
- Year:
- 1 977
- Bibliographic source:
- Toxicol Appl Pharmacol. 1977 Aug;41(2):235-49.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydrocarbons, C10, aromatics
- IUPAC Name:
- Hydrocarbons, C10, aromatics
Constituent 1
Test animals
- Species:
- other: Rats and Dogs
- Strain:
- other: RATS: Harlan Wistar; DOGS: Beagles
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RATS: Harlan
-Number: RATS: 25 males; DOGS: 4 males
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- 25 rats and four dogs per dose were used.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Gas chromatographic analyses of the nominal 0.25, 0.5, and 1.0 mg/liter vapor-air mixtures yielded mean measured concentrations of 0.10, 0.22, and 0.38 mg/liter or 17, 38, and 66 ppm.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
17, 38, and 66 ppm (0.10, 0.22, 0.38 mg/L)
Basis:
analytical conc.
- No. of animals per sex per dose:
- RATS: 6 males/dose (25 total); DOGS: 1 male/dose (4 total)
- Details on study design:
- Methods
Species and number. Twenty-five male rats and four dogs per level were used. Another 20 rats, from the same week of production, were maintained for use as challenge exposure controls (naive rats). The challenge exposures were run to determine whether the 6-hr daily inhalation of a non-lethal level of hydrocarbon, whether by acclimatization or induction of enzymes, would result in the rat becoming more or less resistant than non-exposed or naive controls from the same lot of animals.
Concentrations. A control group (exposed to dilution air) plus groups exposed to three graded levels of test material were utilized for each compound.
Duration. Exposures were 6 hr/day, 5 days/wk for 13 wk.
Observations. Once each week, body weights of both species and food consumption for dogs were determined. Overall appearance and behavior were checked daily.
Procedure. At 3, 8, and 13 wk of exposure three, three, and four rats, respectively, from each group, including controls, were sacrificed. After 13 wk of exposure 10 surviving rats from each group and 20 unexposed rats of the same age were used to detect any significant differences in time to death or in occurrence of signs of distress among the groups. The groups were “challenged” simultaneously by exposure to a vapor air concentration 1.25-2 times the 4-hr rat LC50 until 25 % of the group succumbed or for no more than a 6-hr period. The remaining rats, or those surviving the subacute exposure, exclusive of the ten per level reserved for the challenge exposure were sacrificed after 13 wk and tissues were taken for histopathological interpretation following gross autopsy. The assignment of rats to each of the above groups was made by random selection before the start of the study.
Clinical and hematological schemata. These tests were performed on all dogs initially and prior to sacrifice; and on rats, prior to sacrifice at 3, 8, and 13 wk of exposure. Minimum hematological evaluation for each animal included hematocrit, total erythrocyte count, reticulocyte count, and total and differential leucocyte counts. The biochemical survey included serum alkaline phosphatase, serum glutamic oxoacetic transaminase, serum glutamic pyruvic transaminase, and blood-urea-nitrogen on the rats, and these tests plus bilirubin and blood glucose on the dogs. Initial pre-terminal electrocardiograms were performed on all dogs. Urinalyses were conduct with both species.
Autopsy and pathology schemata. Gross examinations were made of all organ system Histopathological examination included brain (three sections), respiratory (three sections minimum, based on acute exposure data results), heart, thyroid, live kidney, adrenal, spleen, pancreas, stomach and intestines, skeletal muscle, bat marrow, and peripheral nerves. The reproductive organs and eyes were not scheduled for histopathological study unless abnormalities were discovered upon gross examination. Tissues were taken from all dogs and from rats sacrificed after 3, 8, and 13 wk of inhalation of the vapor.
Examinations
- Observations and examinations performed and frequency:
- Observations. Once each week, body weights of both species and food consumption for dogs were determined. Overall appearance and behavior were checked daily.
Clinical and hematological schemata. These tests were performed on all dogs initially and prior to sacrifice; and on rats, prior to sacrifice at 3, 8, and 13 wk of exposure. Minimum hematological evaluation for each animal included hematocrit, total erythrocyte count, reticulocyte count, and total and differential leucocyte counts. The biochemical survey included serum alkaline phosphatase, serum glutamic oxoacetic transaminase, serum glutamic pyruvic transaminase, and blood-urea-nitrogen on the rats, and these tests plus bilirubin and blood glucose on the dogs. Initial pre-terminal electrocardiograms were performed on all dogs. Urinalyses were conduct with both species. - Sacrifice and pathology:
- Autopsy and pathology schemata. Gross examinations were made of all organ system. Histopathological examination included brain (three sections), respiratory tract (three sections minimum, based on acute exposure data results), heart, thyroid, live kidney, adrenal, spleen, pancreas, stomach and intestines, skeletal muscle, bone marrow, and peripheral nerves. The reproductive organs and eyes were not scheduled for histopathological study unless abnormalities were discovered upon gross examination. Tissues were taken from all dogs and from rats sacrificed after 3, 8, and 13 wk of inhalation of the vapor.
- Statistics:
- Statistical analysis. Based on mortality during a 14-day observation period, the most probable LC50 with its fiducial range was calculated by the Thompson method of moving averages using tables by Weil (1952) and other unpublished tables. The results of the quantitative continuous variables, such as body weight changes, were intercompared for the dosage groups and the controls by the use of the following tests: Bartlett’s homogeneity of variance, analysis of variance, rank sum, and Duncan’s multiple range. The latter was used, if F for analysis of variance was significantly high, to delineate which groups differed from the controls. If Bartlett’s test indicated heterogeneous variances, the F test was used for each group versus the control. If these individual F tests were not significant, Student’s t test was used; if significant, the means were compared by the Cochran t test or the rank sum test. Frequency data, such as incidences of mortality or of micro-pathological conditions, were intercompared by the normal deviate of chi square calculated with Yates’ correction for continuity. In all cases the fiducial limit of 0.05 was employed to delineate the critical level of significance.
In general, only criteria that differed statistically significantly from the control group are discussed. Omission of comment is indicative that no valid differences were found. An attempt has been made to round off machine calculated data but if it is obvious that the data portend fictitious accuracy the implication should be ignored.
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:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- RATS. One rat at the 0.10-mg/liter level died after 14 days. Death was attributed to a pneumonic infection as evidenced by extensive lung abscesses. None of the observations were dosage-related and are discounted for that reason.
Significant findings (Rats) - Concentration (mg/liter)
Specific gravity urine, 9 weeks, rats - 0.38 mg/liter - Not dosage-related;
Blood urea nitrogen, 3 weeks, rats 0.10 mg/liter - Not dosage related;
Red blood cell count, Packed cell volume, and Hemoglobin, 9 weeks, rats 0.38 mg/liter - Not dosage-related
Alkaline phosphatase, 9 weeks, rats 0.10 mg/liter - Not dosage-related;
Neutrophil differential, 13 weeks, rats 0.22 mg/liter - Not dosage-related;
Lymphocyte differential, 13 weeks, rats 0.22 mg/liter - Not dosage-related.
DOGS. Pre-exposure polymorphonuclear neutrophilic leucocytes for the 0.1 mg/liter dogs were slightly higher than the controls on an absolute basis, but on the basis of change from pre-exposure after 13 weeks of inhalation, there were no significant differences that were treatment related.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Remarks:
- Rat
- Effect level:
- > 0.38 mg/L air (analytical)
- Sex:
- male/female
- Basis for effect level:
- other: Systemic Toxicity
- Key result
- Dose descriptor:
- NOAEC
- Remarks:
- Dog
- Effect level:
- > 0.38 mg/L air (analytical)
- Sex:
- male
- Basis for effect level:
- other: Systemic Toxicity
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The test material’s NOAEC > 0.38 mg/liter (66 ppm), which was the highest achievable vapor concentration.
- Executive summary:
Twenty-five male rats and four dogs per level were exposed for 6 hr/day, 5 days/wk for 13 wk. Another 20 rats, from the same week of production, were maintained for use as challenge exposure controls (naive rats). The challenge exposures were run to determine whether the 6-hr daily inhalation of a non-lethal level of hydrocarbon, would result in the rat becoming more or less resistant.
One rat at the 0.10-mg/liter level died after 14 days. Death was attributed to a pneumonic infection as evidenced by extensive lung abscesses. None of the observations were dosage-related and are discounted for that reason. The test material’s NOAEC > 0.38 mg/liter (66 ppm), which was the highest achievable vapor concentration.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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