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EC number: 214-317-9 | CAS number: 1120-71-4
- 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
The LD50 value in the rat derived from the key oral acute toxicity study with 1,3-propanesultone is 100 - 200 mg/kg bw. After 6 h inhalation exposure the LC50 in rats was approximately 1.7 mg/L air. After a single dermal application of 830 mg/kg bw to mice 15% of the animals died (LD15). For the rabbit and guinea pig a dermal LD50 of 660 mg/kg bw and 700 - 1400 mg/kg bw has been reported, respectively.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: unspecified
- Vehicle:
- other: undiluted and 10% in water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% - Doses:
- 50 - 3200 mg/kg bw
- No. of animals per sex per dose:
- - No of animals: 16 rats
- Sex: not specified - Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 100 - < 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality occured after 2 hours - 1 day.
- Clinical signs:
- other: Animals were moderately to very weak. They showed prostration, salivation, dark eyes, tremor, gasping, diarrhea and convulsions.
- Gross pathology:
- No abnormalities were found.
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- CLP: Acute Oral 3, H301
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 100 mg/kg bw
- Quality of whole database:
- Old study but meets generally accepted scientific principles, acceptable for assessment
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- - 3 rats were whole body exposed to the test item (2-3 L/min through an open-end bubbler at 97 °C) for 6 hours
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- Type of exposure:
2-3 L/min through an open-end bubbler at 97 °C (chamber temperature 28-28.5 °C) - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 6 h
- Concentrations:
- 2.14 mg /L (425 ppm)
1.3 mg/L (260 ppm) - No. of animals per sex per dose:
- 3 rats per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8 days
- Other examinations performed: clinical signs, body weight - Sex:
- not specified
- Dose descriptor:
- LC100
- Effect level:
- 2.14 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: 2/3 animals died after 24 h, 3/3 animals died in 8 days
- Sex:
- not specified
- Dose descriptor:
- LC0
- Effect level:
- 1.3 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Mortality:
- After being expsosed to 2.14 mg/L for 6 hours 2/3 animals died after 24 h, 3/3 animals died within 8 days and 0/3 animals died after exposure to 1.3 mg/L.
- Clinical signs:
- other: At 2.14 mg/L group: Piloerection and vasodilation: after 3 min Blepharism: after 5 min Lacrimation: 25 min At 1.3 mg/L group: Piloerection: after 5 min Vasodilation: after 15 min Blepharism: after 60 min Lacrimation: 80 min
- Body weight:
- At 1.3 mg/L group:
weight gain of 115 grams on average - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- CLP: Acute Inhal 4, H332
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 700 mg/m³ air
- Quality of whole database:
- acceptable for assessment
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- -The test solutions and solvents were applied to the skin with fine brushes (one application of 25% w/v propane sultone in toluene)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: CFI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - mice were bred in specific pathogen- free conditions at Tunstall Laboratory
- six weeks of age at the beginning of treatment
- water and cubed 86S diet (obtained from Grain Harvesters, Wingham, Kent) were provided ad libitum
- mice were individually housed - Type of coverage:
- not specified
- Vehicle:
- other: toluene
- Details on dermal exposure:
- - the hair on the back was shorn with fine electric clippers before treatment started
- the test solution (0.1 mL) was applied to the dorsal skin using all-glass syringes - Duration of exposure:
- - one single application
- Doses:
- - 25% (w/v) = 25 mg/mouse corresp. to 830 mg/kg bw
- No. of animals per sex per dose:
- - 48
- Control animals:
- yes
- Details on study design:
- The occurence of lethality was observed daily.
Each animal was examined weekly and the size, appearance and position of all skin lesions were recorded.
After 78 weeks, the mice were killed and subjected to a detailed necropsy and a histological examination of skin and the major viscera for the presence of neoplasms. Similar examinations were carried out on animals dying or killed because of ill-health during the experiment, with the exception of those not surviving beyond the first 7 days after exposure. - Sex:
- male/female
- Dose descriptor:
- other: LD15
- Effect level:
- 830 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: - during the first 4 days of the study, 12 males and 2 females died (group size: 48 mice each)
- Mortality:
- - 12 males and 2 females died after 4 days
- Interpretation of results:
- study cannot be used for classification
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only result is given without any information on method
- Principles of method if other than guideline:
- - only result is given without any information on method
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rabbit
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 660 mg/kg bw
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- CLP: Acute Dermal 3, H311
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for asessment.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - guinea pigs were treated dermally with 0.1 - 20 mL/kg test item
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- other: cuff
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- - the undiluted test item was applied dermally (cuff)
- Duration of exposure:
- no data
- Doses:
- 0.1 - 20 mL/kg (corresponding to appr. 0.14 - 28 g/kg)
- No. of animals per sex per dose:
- A total of 12 guinea pigs was used (no further information available)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight - Statistics:
- no data
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- >= 700 - <= 1 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality occured between day 1 and 6.
- Clinical signs:
- other: The symptoms were described in the report as follows: "1, 2, 3 days: Moderate to gross edema and all of patch area and beyond necrotic to 3 erythema or hemorrhagic at perephery. Animals hypothermic and moderate tremors. 6 days: Depressed eschar over
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- CLP: Acute Dermal 3, H311
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 660 mg/kg bw
- Quality of whole database:
- acceptable for assessment
Additional information
Oral route:
After oral administration of 50 - 3200 mg/kg bw to 16 rats (OTS, 1992), the LD50-value determined was in the range of 100 - 200 mg/kg bw. Signs of toxicity were characterised by the observation that the animals were moderately to very weak and showed prostration, salivation, dark eyes, tremor, gasping, diarrhea and convulsions (key study).
Oral LD50 values in the rat of 157 and 350 mg/kg bw have been reported in the 1,3-propanesultone MAK value documentation (MAK, 1985). The oral LD50 in the mouse is 400 mg/kg bw (OTS, 1992).
Results of a limit test performed to assess the acute oral toxicity of the hydroysis product of 1,3-propansulton (3-hydroxypropanesulphonic acid) in rats are also available. Therefore, a group of ten fasted animals (five males and five females) was given a single oral dose as a solution in distilled water at a dose level of 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of dosing and were then killed and subjected to gross pathological examination. One female was found dead 30 minutes after dosing. Clinical signs of toxicity noted in one male during Days 4 to 13 included distended abdomen, dehydration, emaciation, hunched posture, decreased respiratory rate, gasping, laboured and noisy respiration and tiptoe gait. Surviving animals showed an expected gain in bodyweight during the study except for one male which showed bodyweight loss during the first week and expected gain during the second week of the study. Abnormalities noted at necropsy of the female that died during the study were abnormally red lungs, dark liver, dark kidneys, severe haemorrhage of the gastric mucosa and severe haemorrhage of the small and large intestines. No abnormalities were noted at necropsy of animals that were killed at the end of the study. On the basis of these results, the LD50 of the hydrolysis product was determined to be greater than 2000 mg/kg bw.
Inhalation route:
After acute inhalation exposure to the test item for 6 h, LC0 and LC100-values of 1.3 mg/Lair and 2.14 mg/L air (aerosol) in rats were obtained, respectively (OTS, 1992). Thus, a LC50 (6 h) of approximately 1.7 mg/L air was derived.
Dermal route:
The effects of limited and prolonged dermal exposure of mice to 1,3-propanesultone were investigated with specific reference to the occurrence of skin and systemic neoplasia in a carcinogenicity study (Doak, 1976). After single application of 0.1 mL of a 25 %(w/v) solution of 1,3-propanesultone to CFI mice 12 males and 2 females died (group size: 48 mice each) during the first 4 days of the study. Assuming a mean mouse body weight of 30 g a LD15 value of 830 mg/kg bw can be derived. The available experimental data is not sufficient to establish a LD50 value. A dermal LD50 value in the rabbit of 660 mg/kg bw is given in the 1,3-propanesultone MAK value documentation (MAK, 1985). For the guinea pig a dermal LD50 of 700-1400 mg/kg bw (OTS, 1992) has been reported. A second study with guinea pigs (OTS, 1992) was disregarded as the study does not meet basic scientific principles of acute dermal toxicity testing.
Other routes:
An intravenous and subcutaneous LD50 of 210 mg/kg bw in the rat has been reported by Druckrey et al. (1970).
Justification for classification or non-classification
Based on the available experimental data the following classification of 1,3-propanesultone is proposed:
- Oral route: Acute tox. oral cat. 3 (H301: toxic if swallowed) according to CLP (Regulation 1272/2008/EC)
- Inhalation route: Acute tox. inhal. cat. 4 (H332: harmful if inhaled) according to CLP (Regulation 1272/2008/EC)
- Dermal route: Acute tox. dermal cat. 3 (H311: toxic in contact with skin) according to CLP (Regulation 1272/2008/EC).
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