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EC number: 606-834-7 | CAS number: 21806-61-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04. 09. 2019 - 07.11.2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 5H-1,2λ⁶-oxathiole-2,2-dione
- EC Number:
- 606-834-7
- Cas Number:
- 21806-61-1
- Molecular formula:
- C3H4O3S
- IUPAC Name:
- 5H-1,2λ⁶-oxathiole-2,2-dione
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Shijiazhuang Suntec-chem Co., Ltd; 190403
- Expiration date of the lot/batch: Apr 10, 2020
- Purity:99.92%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item does not make a homogenous suspension with water or olive oil, due to our experiences in other experiments, DMSO (dimethylsulphoxide) was used. Immediately before application the test item was weighed, mixed with vehicle DMSO and resulting suspension was administered by gavage. All prepared suspensions of the test item in DMSO were mixed by magnetic stirrer during administration.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF breeding, VELAZ s.r.o., Lysolajské údolí 15/53, 165 00 Prague 6, Czech Republic, RČH CZ 11760500
- Females (if applicable) nulliparous and non-pregnant: Yes
- Weight at study initiation: 202.58 to 231.96 g
- Fasting period before study: About twenty hours before oral administration the animals were fasted
- Housing: Individual labelling of cages and labelling of the animals, three animals per cage; Monitored conditions, microbiologically defined background.
- Diet: Pelleted standard diet for experimental animals ad libitum (Altromin International, Altromin Spezialfutter GmbH & Co. KG, Germany) ad libitum
- Water: Drinking tap water ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 – 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light/dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 1 mL/100 g of animal body weight
- Justification for choice of vehicle: The test item does not make a homogenous suspension with water or olive oil, due to the lab's experiences in other experiments, DMSO (dimethylsulphoxide) was used.
- Lot/batch no. (if required): 2103180316
- Purity: 99.0%
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was 300 mg/kg bw, according the test guideline, because there is no information about toxicity from sponsor. - Doses:
- Step 1: 300 mg/kw bw
Step 2: 300 mg/kw bw
Step 3: 50 mg/kg bw
Step 4: 50 mg/kg bw - No. of animals per sex per dose:
- 3 females per dose per step.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were daily observation and weighed before application, at the 8th day of study and at the 15th day.
- Necropsy of survivors performed: yes
- Other examinations performed:
1. Clinical signs: After application the animals were observed individually: the first day: twice (30 minutes and 3 hours after application) and the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days. Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system. The results of the observations were recorded on special data sheets.
2. Pathological examination: All test animals that survived to the end of study were sacrificed on the 15th day and gross necropsy was carried out. Animals that died during the study were also examined. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. All gross macroscopic changes of organs and tissues were recorded - Statistics:
- Average body weight in a group was calculated from individual body weights (mean and SD)
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Mortality:
- At the dose level 300 mg/kg bw (group No. 1 and 2), Female No. 1 was found dead on the morning of the second day (Table 5). Female No. 4 died five hours after application. Female No. 6 was found dead on the morning of the second day (Table 6). The dose of 50 mg/kg bw (group No. 3 and 4) did not cause any deaths.
- Clinical signs:
- other: At the dose level 300 mg/kg bw (group No. 1 and 2), no clinical signs of intoxication were observed 30 minutes after application in all 6 females. The following symptoms were observed 3 hours after application at 300 mg/kg bw: piloerection, anemia of visi
- Gross pathology:
- At 300 mg/kg bw, the following pathological macroscopic changes were found in animals that died before the end of the study: hyperemia of stomach mucous membrane in females No. 1, 4 and 6, and erosions of stomach mucous membrane in female No. 6. No pathological macroscopic changes were found in females No. 2, 3 and 5 (Tables 9, 10).
No pathological macroscopic changes were diagnosed during examination of animals dosed at 50 mg/kg bw in group No. 3 and No. 4 (Tables 11, 12).
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- In an acute oral toxicity study in female Wistar Crl: WI(Han) rats, the LD50 was > 50 mg/kg to 300 mg/kg bw.
- Executive summary:
In an acute oral toxicity test (152-19-1), 4 groups of female Wistar Crl: WI(Han) rats (3/group) were administered 1,3 Propene Sultone (99.92%) in DMSO by oral gavage at 300 mg/kg bw (2 steps) and 50 mg/kg bw (2 steps). Animals were observed for 14 days.
The LD50 was > 50 mg/kg - 300 mg/ kg bw.
No clinical signs of intoxication were observed 30 minutes after application in all 6 females at 300 mg/kg bw. The following symptoms were observed 3 hours after application at 300 mg/kg bw: piloerection, anemia of visible mucous membranes, abdominal position, ataxia, decrease response to stimuli, bradypnea in two females, abdominal position in four females. On the morning of the second day, piloerection was observed in females No 2 and 3. From the afternoon of the second day to the fourteenth day, no clinical signs of intoxication were observed in surviving females. Weight increments were adequate to species, sex and age of animals during the experiment. The test item administered at the dose of 300 mg/kg bw caused the death of 3 of 6 animals. Two females were found dead on the morning of the second day after application of the test item. One female died five hours after application. The following pathological macroscopic changes were found in animals that died before the end of the study: hyperemia of stomach mucous membrane in females No. 1, 4 and 6, and erosions of stomach mucous membrane in female No. 6. No pathological macroscopic changes were found in surviving females.
The test item administered at the dose of 50 mg/kg bw caused no death of any animal. No serious clinical signs of intoxication were detected at this dose during the whole study. Weight increments were adequate to species, sex and age of animals during the experiment. No macroscopic changes were diagnosed during the pathological examination.
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