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Diss Factsheets
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EC number: 201-058-1 | CAS number: 77-78-1
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted before OECD guidelines were established. The major endpoint is cancerogenicity without evaluation of standard parameters for repeated dose toxicity (haematology, clinical biochemistry) and histopathological examinations were limited to the lungs and trachea. N(L)OELs can not be established based on the study results and the study is therefore not usefull for RA purposes.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Cancerogenität und chronische Toxizität inhalierten Dimethylsulfats.
- Author:
- Schlögel, F.A.
- Year:
- 1 972
- Bibliographic source:
- Dissertation, University Faculty of Medicines, Würzburg, Germany
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Animals were observed for at least 30 months after start of exposure. Examinations included clinical signs, mortality, body weights, lung weights, gross pathology and histopathology. Histopathological examination was restricted to lungs and trachea. When gross examination revealed a tumour in other tissues/organs, this tissue/organ was included for histopathological examination.
- GLP compliance:
- no
Test material
- Reference substance name:
- Dimethyl sulphate
- EC Number:
- 201-058-1
- EC Name:
- Dimethyl sulphate
- Cas Number:
- 77-78-1
- Molecular formula:
- C2H6O4S
- IUPAC Name:
- dimethyl sulfate
- Details on test material:
- - Name of test material (as cited in study report): Dimethyl sulphate
No further details are given.
Constituent 1
Test animals
- Species:
- other: rat (1), mosue (2) and hamster (3)
- Strain:
- other: Wistar (1) and NMRI (2) and Syrian (3)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS rats
- Source: "Zentralinstitute für Versuchstierzucht", Hannover, Germany
- Weight at study initiation: 117 g to 332 g
- Housing: groups of 5, 10 or 15 animals per sex per cage
- Diet: standard diet "sniff M" ad libitum
- Water: tap water ad libitum
TEST ANIMALS: mouse
- Source: "Zentralinstitute für Versuchstierzucht", Hannover, Germany
- Weight at study initiation: 24.3 g to 36.9 g
- Housing: groups of 5, 10 or 15 animals per sex per cage
- Diet: standard diet "sniff M" ad libitum
- Water: tap water ad libitum
TEST ANIMALS: hamster
- Source: Fa. Rudi Schneider, Rottach-Egern or Fa. G. Ansers, Edenkoben
- Weight at study initiation: 60 g to 105 g
- Housing: groups of 3 to 7 animals per sex per cage
- Diet: standard diet "sniff M" ad libitum, salat, carrots, sunflower seeds and oat flakes
- Water: tap water ad libitum
No further details are given.
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: an exposure chamber with a volume of 940.5 liters was used.
- Method of holding animals in test chamber: the exposure chamber was divided in three levels to hold more animals in the chamber at the same time.
- The DMS-gas-air mixture was induced into the chamber at different levels.
- Temperature, humidity, pressure in air chamber: all animals were maintained at 23°C and 60% relative humidity. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Gaschromatography was used for the quantitative verification of the DMS concentration in the chamber.
- Duration of treatment / exposure:
- approximately 15 months
- Frequency of treatment:
- 6 hours per day either daily or twice a week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.0 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0.5 ppm (2.6 mg/m3)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
2 ppm (10.5 mg/m3)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
34 ppm (175.35 mg/m3)
Basis:
nominal conc.
- No. of animals per sex per dose:
- (1) 5-15
(2) 5-15
(3) 3-16 - Control animals:
- yes
- Details on study design:
- no data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: animals were observed daily; in case of mortality, animals were autopsied.
BODY WEIGHT: Yes
- Time schedule for examinations: all animals were weighed twice per week prior exposure.
ORGAN WEIGHT: Yes
- Time schedule for examinations: removed lungs and tracheas were weighed before fixed and prepared for sections.
No further details are given. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
After macroscopic analysis, lung, trachea, liver, kidneys and organs with carcinomas were removed and fixed in BOUIN's solution and sections were prepared
HISTOPATHOLOGY: Yes
Sections from tissues including tumourous tissues were analysed histopathologic.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- treatment related in rats only
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- A remarkable finding was the very low survival time in male and female rats.
HISTOPATHOLOGY: NON-NEOPLASTIC
- An increase in the incidence of inflammation of the lungs was reported in DMS-exposed animals in all species.
- Bronchiopneumonia occurred at about the same degree in control and DMS exposed animals.
HISTOPATHOLOGY: NEOPLASTIC
- The incidence of benign tumours of the subcutis and lungs and the incidence of animals with malignant respiratory tract tumours per number of animals examined with histological classification of the tumours is given.
- DMS exposure resulted in an increased incidence of malignant tumours in the respiratory tract (nose and lungs).
- Rats were most sensitive to the tumour inducing activity of DMS, while hamsters were the least sensitive.
- In all three animal species females appeared more sensitive than males.
- In female rats of the 10.5 mg/m3 group the incidence of lung adenomas was slightly higher than in control females.
- There were no indications that DMS exposure induced an increase in subcutaneous fibromas.
- The highest incidence of animals with treatment-related malignant respiratory tract tumours was found in rats exposed to 10.5 mg/m3 group.
- The incidence in the 2.6 mg/m3 group was distinctly lower although the total dose in the low dose group was comparable or higher than that in the 10.5 mg/m3 group.
- This lower incidence might be related to the lower mean survival time in the 2.6 mg/m3 group, which in its turn may be a consequence of the initially high exposure scheme applied to this group.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Inhalation exposure to DMS induced treatment-related tumours in rats only. In this context it must be realised that the exposure scheme applied for the sublethal concentration of 175.35 mg/m3 leads to a lower total dose than that used with the 2.6 and 10.5 mg/m3-groups. Moreover most animals of the sublethal group have been exposed four times only.
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