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EC number: 232-216-8 | CAS number: 7790-62-7
- 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 (based on read across to H2SO4 with correction for molecular weight differences): similar to OECD 401; rat LD50: 5547 mg/kg. Reliability = 2
Inhalation (based on read across to H2SO4 with correction for molecular weight differences): similar to OECD 403; rat 4-hr LC50: 972 mg/m3. Reliability =2
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated 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: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect dated 2001.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Carworth-Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-5 weeks of age
- Weight at study initiation: 90-120 grams
- Fasting period before study: no - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.250 g/mL - Doses:
- - The doses were arranged in a logarithmic series differing by a factor of two.
- Concentration in vehicle: 0.250 g/mL - No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 140 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 1540-2990 mg/kg
- Conclusions:
- This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 = 2140 mg/kg - Executive summary:
An acute oral toxicity study with the test substance on groups of 5 rats reported an LD50 of 2140 mg/kg/body weight.
Reference
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 5 547 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated 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: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Animals observed for 21 days
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6-7 weeks - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: humid air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 27-inch Rochester-type chronic exposure chamber
- Method of holding animals in test chamber: individual cages
- System of generating particulates/aerosols: mixing SO3 with humid air to produce H2SO4 droplets
- Source and rate of air: 10 cfm
- Temperature, humidity, pressure in air chamber: 40% humidity; temperature and pressure not reported
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter): 1.1 - 2.2 µm - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- >= 1 - <= 8 h
- Remarks on duration:
- selected exposure times were 1, 2, 4 and 8 hours for each concentration
- Concentrations:
- 240, 470, 730, 800, 1080 and 1090 mg/m³
- No. of animals per sex per dose:
- 8
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology; Animals dying spontaneously and sacrificed animals were necropsied. The time of death was noted, and the lung, trachea, stomach and turbinates were removed, fixed in 10% formalin and processed for histologic examination using standard procedures. - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 375 mg/m³ air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- Mortality was 0, 63, 63, 75, 63 and 88% after 4-hour exposure to 240, 470, 730, 800, 1090 and 1080 mg/m³, respectively.
The majority of rats died during the 2 weeks after exposure. Exceptions to this were early deaths which occurred when rats were exposed to H2SO4 concentrations above 700 mg/m3 for 4 to 8 hours. - Gross pathology:
- Examination of rat tissues revealed ulceration of turbinates, trachea and larynx in animals dying during exposure or shortly thereafter. Lesions noted in rats dying 1-2 weeks after exposure included fibrosis of the larynx and bronchopneumonia associated with aspirated foreign material.
- Other findings:
- Rats showed increased mortality with increased concentration. This appeared more dramatically in mice than in rats during the first 24 hours. The fact that deaths occurred within 24 hours in the mouse group exposed for 1 and 2 hours and not in the rat group may be interpreted as an indication of greater sensitivity in the mouse. When total deaths in 21 days were considered, however, the rat appeared to exhibit increased sensitivity with increased H2S04 concentration as did the mouse. In fact, rat mortality increased more rapidly with increased concentration than mouse mortality. No deep lung lesions were noted in rats that could be attributed to direct test substance insult. Animals died from upper respiratory tract lesions before test substance aerosol concentrations affected the deep lung.
- Interpretation of results:
- moderately toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LC50 was approximately 375 mg/m³ for rats. - Executive summary:
Rats (Fischer-344) were exposed to various concentrations of test substance aerosols for 1 to 8 hours. Mortality and histologic changes resulting from these exposures were determined. Mortality in the majority of rats occurred 1-2 weeks following exposure, the exception being early deaths resulting from very high aerosol concentrations. Examination of tissues revealed ulceration of the turbinate, trachea and larynx in rats dying during exposure or shortly thereafter. Lesions noted in rats dying 1-2 weeks after exposure included bronchopneumonia associated with aspirated foreign material. No deep lung lesions were noted in rats that could be attributed to direct test substance insult. Animals died from upper respiratory tract lesions before test substance aerosol concentrations affected the deep lung. The LC50 for rats was approximately 375 mg/m³.
Reference
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 972 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data were available for acute oral, dermal, or inhalation toxicity with the test substance, but oral LD50 and inhalation LC50 studies in rats with H2SO4 were used as a read across to fulfil the data gap for the test substance. The underlying hypothesis for the read-across between the test substance and H2SO4 is the likelihood of common precursors and/or breakdown products, via physical or biological processes, which result in structurally similar chemicals (e.g. the metabolic pathway approach of examining related chemicals such as acid/ester/salt). Additional documentation, provided within the IUCLID Assessment Reports section, supports the read-across approach. Therefore, it is reasonable to read-across the information from the acute oral and inhalation studies with H2SO4 to address the data gap for the test substance. The rat oral LD50 for H2SO4 was 2140 mg/kg, which when corrected for test substance/H2SO4 molecular weight differences, would yield an equivalent test substance oral LD50 of 5547 mg/kg. The rat inhalation LC50 for H2SO4 was 375 mg/m3,which when corrected for test substance/H2SO4 molecular weight differences, would yield an equivalent test substance 4-hour LC50 of 972 mg/m3.
Justification for selection of acute toxicity – oral endpoint
LD50 is based on read across to acute inhalation study with H2SO4 (Scientifically valid study, similar to OECD guideline), which corrected for test substance/H2SO4 molecular weight differences, would yield an equivalent test substance oral LD50 of 5547 mg/kg.
Justification for selection of acute toxicity – inhalation endpoint
LC50 is based on read across to acute inhalation study with H2SO4 (Scientifically valid study, similar to OECD guideline), which corrected for test substance/H2SO4 molecular weight differences, would yield an equivalent test substance 4-hour LC50 of 972 mg/m3
Justification for classification or non-classification
The acute inhalation LC50 in rats with H2SO4 was 375 mg/m3, which when corrected for test substance/H2SO4 molecular weight differences, would yield an equivalent test substance 4-hour LC50 of 972 mg/m3. Therefore, the test substance is classified as T, R23 (toxic by inhalation (gas, dust/mist) for acute inhalation toxicity according to EU Directive 67/548/EEC and Cat 3 (H331: toxic if inhaled) for acute inhalation toxicity according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) regulation (EC) No. 1272/2008. Since the pH of the substance is ≤2 when in contact with biological fluids at 0.1M or greater, it is classified as a corrosive material. Therefore, the label EUH071(corrosive to the respiratory tract) is required according the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) regulation (EC) No. 1272/2008
Based on the oral LD50 in rats with H2SO4 of 2140 mg/kg, which when corrected for test substance/H2SO4 molecular weight differences, would yield an equivalent test substance oral LD50 of 5547 mg/kg, no classification is required for acute oral toxicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Data lacking due to waiving arguments, therefore the test substance cannot be classified for acute dermal toxicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.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.
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