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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose 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.
Data source
Reference
- Reference Type:
- publication
- Title:
- Response in the Respiratory Tract of Rats Following Exposure to Sulphuric Acid Aerosols for 5 or 28 Days
- Author:
- Kilgour JD, Foster J, Soames A, Garrar DG, and Hext PM
- Year:
- 2 002
- Bibliographic source:
- J. Appl. Toxicol., 22:387-395
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- yes
- Remarks:
- Exposure for 5 or 28 days; pathology limited to the respiratory tract
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sulphuric acid
- EC Number:
- 231-639-5
- EC Name:
- Sulphuric acid
- Cas Number:
- 7664-93-9
- IUPAC Name:
- sulfuric acid
- Details on test material:
- - Purity: 49.7 wt.% H2SO4
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: ALPK:APfSD (Wistar)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Rats were housed 5 per cage, in multiple rat racks suitable for animals of this strain and the weight range expected during the course of the study.
The rats were transferred to clean cages and racks as necessary during the study. Both temperature and relative humidity were measured and recorded daily and the recorded values were within the specified ranges.
Diet (CT1) supplied by Special Diet Services Limited, Witham, Essex, UK and mains water, supplied by an automatic system, were available ad libitum, except during exposure.
Each batch of diet was routinely analysed for composition and for the presence of contaminants. Water was also periodically analysed for the presence of contaminants. No contaminants were found to be present in the diet or water at levels considered to be capable of interfering with the purpose or outcome of the study. The animals were housed under the experimental conditions for 13 days at CTL, prior to the start of the study. The study was divided into 2 replicates (randomised blocks), each containing 10 cages, one per treatment group. Computer-generated, random number permutations were used to allocate the cages within each replicate to an experimental group.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30–70%
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h per day of fluorescent light.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: Particle sizes were 0.62, 0.83 and 0.94 µm, respectively.
- Details on inhalation exposure:
- The rats were exposed nose-only to the test atmospheres. Animals were restrained in polycarbonate tubes supplied by Battelle, Geneva, Switzerland. These were inserted into a PERSPEX exposure chamber. The chamber was covered with a stainless steel cone and stood on a stainless steel base. The atmosphere was shown to be acceptably stable over approximately 30 minutes before exposure of the test animals. During this period the holes of the exposure chamber were plugged. The animals were exposed for 6 hours per day, 5 days per week, for a period of 28 days. Test atmospheres were generated using a glass concentric - jet atomiser to generate atmospheres into 2 reservoir chambers (each fitted with a cyclone), one serving the exposure chambers for groups 4&5 and 6&7, and another serving exposure chambers for groups 8, 9 & 10. Clean, dry air (dried and filtered using equipment supplied by Atlas-Copco, Sweden) was passed through the atomiser at nominal flow rates for each group respectively and carried the atmosphere to each of the exposure chambers (internal volume of 36.8 litres), in order to achieve a minimum of 12 air changes per hour. Air flows were monitored and recorded at approximately 30 minute intervals using variable area flowmeters (KDG Flowmeters, Burgess Hill, Sussex, UK) and were altered as necessary to maintain the target concentrations.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The particulate concentration of each test atmosphere, close to the animals’ breathing zone, was measured gravimetrically at least twice during exposure. This was done by drawing each test atmosphere, at a known flow rate, for a known time, through a 25 mm diameter, polyvinyl chloride (PVC) GN-4 filter housed in a Delrin open-faced filter holder (both filters and holders supplied by Gelman Sciences Limited, Northampton, UK). The filter was weighed before and after the sample was taken. The aerodynamic particle size distribution of each test atmosphere was measured at least once during exposure period, using a Marple Cascade Impactor (supplied by Schaeffer Instruments Limited, Wantage, Oxon, UK) which aerodynamically separates airborne particles into pre-determined size ranges. The amount of aerosol, by weight, in each size range, was then used to calculate the aerodynamic particle size distribution of the aerosol. Using a microcomputer, the data were transformed using a log/probit transform and a linear regression derived from the cumulative data.
Using this regression line, the mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) were calculated. - Duration of treatment / exposure:
- 5 or 28 days
- Frequency of treatment:
- 6 hours/day; 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.00, 0.2, 1.0, 5.0 mg/m3
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0.00, 0.30. 1.38, 5.52 mg/m3
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10 females
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- For examination of effects in the lung, 5 designated rats per group, per time point, were implanted subcutaneously with osmotic minipumps (Alzet 2ML1) for delivery of BrdU 7 days before termination. The minipumps contained BrdU at a concentration of 15 mg/mL.
At post mortem, the lungs (tracheas attached but larynx removed) were excised and weighed, prior to inflation with 10% neutral buffered formalin. The lungs were fixed in 10% neutral buffered formalin for 24 hours. The tissue was trimmed and processed to paraffin wax blocks and sections made and stained to reveal BrdU positive nuclei. Labelling indices (LI) were determined for the central acinar region and in the terminal bronchiole regions of the lung. LI were determined by counting the number of BrdU labelled cell nuclei and the total number of cell nuclei (labelled and non labelled). LI were then determined by dividing the number of BrdU labelled cells by the total number of labelled and non labelled cells, the result being expressed as a percentage. Labelling indices were determined for the small intestine. The small intestine has an inherently high rate of cell turnover and as such acts as a positive control for the BrdU immunostaining. Pulse labelling with tritiated thymidine, followed by autoradiography, was used for the assessment of rate of cell proliferation in the nasal passages; thymidine being incorporated into DNA during s-phase.
Five designated rats per group were injected intra-peritoneally with tritiated thymidine at a dose level of 1µCi/g body weight, approximately one hour prior to scheduled termination. At post mortem, the heads from all designated animals were removed, excess skin and muscle removed, the brain excised and the nasal cavity perfused with 10% formol saline through the nasopharynx. The head was then immersed in formol saline followed by decalcification with 20% formic acid. After processing, six standard sections were produced to include all different epithelial cell types and accessory nasal structures. The six sections were exposed to nuclear emulsion (Ilford K2) for 8-10 weeks. Sections were developed and examined by light microscopy. Labelling indices (LI) were determined for each of the 6 nasal passage levels. LI were determined by counting the number of thymidine labelled cell nuclei and the total number of cell nuclei (labelled and non labelled). LI were then determined by dividing the number of thymidine labelled cells by the total number of labelled and non labelled cells, the result being expressed as a percentage. Where more than one section was examined from a tissue, results for each level of that tissue are reported separately. - Sacrifice and pathology:
- From all animals surviving to scheduled termination (day 29 for main study animals and after 4 or 8 weeks monitoring in recovery animals), the lungs were removed, trimmed free of extraneous tissue and weighed (with trachea attached but larynx removed, each pair of lungs weighed together). At post mortem the larynx was removed from all animals and fixed in 10% neutral buffered formalin for 24 hours. The tissues were trimmed and processed to paraffin wax blocks and three standard sections of larynx produced, taken at the level of the base of the epiglottis, through the ventral pouch and the cricoid cartilage to include all different epithelial cell types of the larynx and underlying seromucinous glands.
Standard sections of larynx from animals receiving BrdU were stained to reveal BrdU positive nuclei, while those from animals receiving thymidine, were exposed to nuclear emulsion (Ilford K2) for 8-10 weeks before being developed. For both the BrdU and thymidine animals, cell replication rates in the larynx were expressed as unit length labelling indices (ULLI).
In ULLI’s, the basement membrane length is substituted for the total cell count in the labelling index equation. ULLI’s were determined by counting the number of BrdU (and thymidine) labelled nuclei and dividing the result by the length of underlying basement membrane; ULLI’s being expressed as the number of BrdU (or thymidine) labelled cells per unit length (mm) of epithelium. The length of the basement membrane was determined using a Kontron Image Analyser attached to a Leitz light microscope. - Statistics:
- All data (except cell proliferation data) were evaluated using analysis of variance and/or covariance for each specified parameter using the MIXED procedure of the SAS Institute (1989) and were carried out separately for the main study and for recovery animals. Cell proliferation data was analysed using ARTEMIS statistical methods (two-sided Student’s test).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- 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:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 0.3 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Findings at 0.3 mg/m3 were limited to minimal metaplastic change after 28 days, considered to be an adaptive response to a respiratory irritant.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There were no deaths, no signs of toxicity, and no adverse effects on body weight or lung weight in any treatment group. There were no macroscopic findings in animals killed at term. Microscopically, no treatment related changes were seen in either the lung or the nasal cavity. The major treatment related effect was squamous metaplasia of the ventral epithelium of level 1 of the larynx, the severity of which was concentration-dependent. In the 5-day satellite study, the NOAEC for this effect was 0.30 mg/m3. In the 28-day study, squamous metaplasia of the larynx was seen at all concentrations (including minimal squamous metaplasia in 3/10 animals exposed to 0.30 mg/m3); the severity of this finding was directly related to exposure concentration. After 4 and 8 weeks recovery following exposure to the highest concentration (5.52 mg/m3) evidence of metaplasia remained, although it was less severe than that seen immediately following the 28-day exposure period. No increases in cell proliferation were detected in either the lung or the nasal cavity at either 5 or 28 days; results were in agreement with the pathological assessment. In the larynx, a treatment related increase in cell turnover was seen in the same region of level 1 as the exposure related pathological finding of squamous metaplasia, with a NOAEC for this finding of 0.30 mg/m3 for both 5 and 28 days.
Applicant's summary and conclusion
- Conclusions:
- This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Female NOAEC = 0.3 mg/m³ air (analytical)
Following inhalation exposure to sulphuric acid mists, treatment-related findings were limited to histopathology and cell proliferation of the larynx, consistent with a local irritant effect of the substance - Executive summary:
Groups of female rats were exposed to aerosols of sulphuric acid (mists) at target concentrations of 0, 0.2, 1.0 or 5.0 mg/m3 for 6 hours a day, 5 days a week for 5 or 28 days. Additional groups exposed to 0 or 5.0 mg/m3 (nominal concentration) for 28 days were investigated following recovery periods of 4 or 8 weeks. Effects of exposure were limited to the larynx. Squamous metaplasia and significant cell proliferation was seen following exposure to 1.38 and 5.52 mg/m3 for 5 and 28 days; findings had decreased in severity following the recovery periods. Findings following exposure to 0.3 mg/m3 for 28 days were limited to minimal metaplasia (with no proliferation); no effects were apparent following exposure to 0.3 mg/m3 for 5 days. The NOAEC for this study is therefore considered to be 0.3 mg/m3.
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