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EC number: 203-841-3 | CAS number: 111-17-1
- 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
Endpoint summary
Administrative data
Description of key information
oral LD50 > 2000 mg/kg bw (rat, equivalent to OECD TG 401)
inhalation LC50 (4 h) >5.13 mg/L air (rat, OECD TG 403)
dermal LD40 > 2000 mg/kg bw (rat, OECD TG 402)
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only translated summary available, actual guideline not stated.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Only summary available, guideline not stated
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Age at study initiation: 5 weeks
- Weight at study initiation: males 133-150 g, females 111-126 g
- Fasting period before study: 18 h before until 3 h after dosing
- Housing: 5/cage
- Diet (e.g. ad libitum): solid feed for experimental animals (MF, Oriental Yeast Co. Ltd.), ad libitum
- Water (e.g. ad libitum): sterile-filtered and UV-radiated tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±15
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL in 0.5 % CMC-Na aqueous solution (CMC-Na, Wako Pure Chemical Industries; Water for injection: Otsuka Pharmaceutical Factory)
- Amount of vehicle (if gavage): 10 mL/kg bw, calculated based on the bodyweight determined immediately prior to administration.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
DOSAGE PREPARATION (if unusual): Preparation of test substance suspension in CMC-solution 6 days in advance of administration. - Doses:
- 0, 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Survival, appearance, mobility, and other abnormalities on administration day immediately prior to administration and 0.5, 1, 3, and 6 hours after administration, then once a day thereafter for the rest of the observation period; bodyweight was measured immediately prior to administration (day 1) and then on days 2, 4, 8, 10, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- F test was performed on bodyweights, in case of equal variance they were subjected to Student's t-test, in case of unequal variance they were subjected to Aspen-Welch's t-test. Significance level was 5 %.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No effects were observed.
- Gross pathology:
- No effects were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study equivalent to OECD TG 401, Crj: CD(SD) fasted rats (5/sex/dose) were orally administered with 0 (control) and 2000 mg/kg bw 3,3'-Thiobispropanoic acid in 0.5 % carboxymethyl cellulose by gavage. Animals were then observed for 14 d. No mortality occurred. No clinical signs were observed. There was no significant difference compared to controls. A low value for males in the treated group was found on day 8 due to food not being given to those animals from day 7 to day8. This observation was not attributed to test material administration. At necropsy, no macroscopic effects were observed. The LD50 was >2000 mg/kg bw.
Reference
The test substance does not need to be classified according to the criteria of DSD or CLP.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent.
- Age at study initiation: approximately eight to twelve weeks old
- Weight at study initiation: weight range of 200g to 350g
- Fasting period before study:
- Housing: The animals were housed in groups of five by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood f akes (Datesand Ltd., Cheshire, UK) and provided with environmental enrichment items: wooden chew blocks (B & K Universal Ltd, Hull, UK) and cardboard “fun tunnels” (Datesand Ltd., Cheshire, UK).
- Diet (e.g. ad libitum)+ Water (e.g. ad libitum): With the exception of the exposure period, free access to mains drinking water and food (EU Rodent Diet 5LF2, BCM IPS Limited, London, UK) was allowed throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: approximately 30 litres (dimensions: 28 cm diameter x 50 cm high)
- Method of holding animals in test chamber: Each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier
of the exposure chamber and sealed by means of a rubber ‘O’ ring. Only the nose of each animal was exposed to the test atmosphere.
- Method of conditioning air: Compressed air was supplied by means of an oil free compressor and passed through a water trap and respiratory quality filters before it was introduced to the SAG 410.
- System of generating particulates/aerosols: A dust atmosphere was produced from the test material using a SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany) located adjacent to the exposure chamber. The SAG 410 was connected to a metered compressed air supply. A particle separator was introduced before the aerosol entered the exposure chamber in order to remove large particles and thereby increase the inhalable por ion of the generated aerosol.
- Method of particle size determination: Marple Personal Cascade Impactor (Westech IS Ltd, Beds., UK).
- Temperature, humidity, pressure in air chamber: The environmental controls were set to achieve values of 19 - 25°C and 30 - 70% relative
humidity.
- Duration of exposure:
- 4 h
- Concentrations:
- 5.13 mg/L
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.13 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- One animal showed a rapid decline in condition on Day 10 and was subsequently humanely killed, this animal exhibited significant weight loss and observations now included decreased respiratory rate, laboured respiration, noisy respiration, lethargy, hunched posture, piloerection and red/brown staining around the snout.
- Clinical signs:
- other: During exposure, there were frequent instances of increased respiratory rate. On removal from the chamber, animals showed increased respiratory rate and noisy respiration. One hour after removal, no change in the condition of the animals was observed. One
- Body weight:
- All male animals exhibited bodyweight loss or reduced bodyweight gain during Week 1, four of these animals recovered to show normal development during Week 2. Normal bodyweight development was noted for all female animals during the study.
- Gross pathology:
- Apart from one instance of dark patches on the lungs no macroscopic abnormalities were detected amongst animals that survived until Day 14 at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute inhalation toxicity study according to OECD TG 403 Sprague-Dawley rats (5/sex) were exposed to 5.13 mg/L air 3,3'-Thiobispropanoic acid (nose only; dust) for 4 h. Animals were then observed for 14 d.
One animal showed a rapid decline in condition on Day 10 and was subsequently humanely killed, this animal exhibited significant weight loss and observations now included decreased respiratory rate, laboured respiration, noisy respiration, lethargy, hunched posture, piloerection and red/brown staining around the snout.
During exposure, there were frequent instances of increased respiratory rate. On removal from the chamber, animals showed increased respiratory rate and noisy respiration. One hour after removal, no change in the condition of the animals was observed. One day after exposure, all animals exhibited increased respiratory rate, hunched posture and piloerection. There were frequent instances of noisy respiration and red/brown staining around the head. The majority of animals showed good signs of recovery over the recovery period, one animal exhibited a scab on the head on Days 8 and 9 but this was not considered to be treatment related. Female animals recovered quicker than male animals such that they appeared normal from Days 3 to 8 post-exposure. Three out of the four surviving male animals appeared normal from Days 5 to 12, however, one male animal still exhibited noisy respiration by Day 14.
All male animals exhibited bodyweight loss or reduced bodyweight gain during Week 1, four of these animals recovered to show normal development during Week 2. Normal bodyweight development was noted for all female animals during the study.
Apart from one instance of dark patches on the lungs no macroscopic abnormalities were detected amongst animals that survived until Day 14 at necropsy.
The 4 h LC50 was 5.13 mg/L air.
Reference
Mortality Data:
Mean Achieved Atmosphere Concentration (mg/L)
|
Deaths:
|
||
Male |
Female |
Total |
|
5.13 |
1/5 |
0/5 |
1/10 |
Only one death occurred in a group of ten rats exposed to a mean achieved atmosphere
concentration of 5.13 mg/L for four hours. It was therefore considered that the acute inhalation
median lethal concentration (4 hr LC50) of TDPA, in the Sprague-Dawley Crl:CD® (SD) IGS BR
strain rat, was greater than 5.13 mg/L.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5.13 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent.
- Age at study initiation: approximately eight to twelve weeks old
- Weight at study initiation: approximately 200g
- Housing: The animals were housed in groups of five by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood f akes (Datesand Ltd., Cheshire, UK) and provided with environmental enrichment items: wooden chew blocks (B & K Universal Ltd, Hull, UK) and cardboard “fun tunnels” (Datesand Ltd., Cheshire, UK).
- Diet (e.g. ad libitum)+ Water (e.g. ad libitum): Free access to mains drinking water and food (EU Rodent Diet 5LF2, BCM IPS Limited, London, UK) was allowed throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shorn skin
- % coverage: approximately 10 % of the body surface
- Type of wrap if used: surgical gauze was placed over the treatment area and semi-occuled with a peace of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin and surrounding hair wiped with cotton wool moistured with distilled water to remove any residual test material. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- ten animals (five males and five females)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality during the study
- Clinical signs:
- other: No signs of systemic toxicity
- Other findings:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study according to OECD TG 402, Sprague-Dawley rats (5/sex/dose) were dermally exposed to 2000 mg/kg bw 3,3'-Thiobispropanoic acid in water for 24 h under semiocclusive conditions. Animals were then observed for 14 d.
No mortality occurred during the study. No signs of systemic toxicity were observed. All animals showed the expected gains in bodyweight over the study period.
The dermal LD50 was >2000 mg/kg bw.
Reference
The acute dermal median lethal dose (LD50) of the test material in the Sparque-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral toxicity
In an acute oral toxicity study equivalent to OECD TG 401, fasted Crj: CD(SD) rats (5/sex/dose) were orally administered with 0 (control) and 2000 mg/kg bw 3,3'-Thiobispropanoic acid in 0.5 % carboxymethyl cellulose by gavage. Animals were then observed for 14 d. No mortality occurred. No clinical signs were observed. There was no significant difference compared to controls. A low value for males in the treated group was found on day 8 due to food not being given to those animals from day 7 to day 8. This observation was not attributed to test material administration. At necropsy, no macroscopic effects were observed. The LD50 was >2000 mg/kg bw.
inhalation toxicity
In an acute inhalation toxicity study according to OECD TG 403 Sprague-Dawley rats (5/sex) were exposed to 5.13 mg/L air 3,3'-Thiobispropanoic acid (nose only; dust) for 4 h. Animals were then observed for 14 d.
One animal showed a rapid decline in condition on Day 10 and was subsequently humanely killed, this animal exhibited significant weight loss and observations now included decreased respiratory rate, laboured respiration, noisy respiration, lethargy, hunched posture, piloerection and red/brown staining around the snout.
During exposure, there were frequent instances of increased respiratory rate. On removal from the chamber, animals showed increased respiratory rate and noisy respiration. One hour after removal, no change in the condition of the animals was observed. One day after exposure, all animals exhibited increased respiratory rate, hunched posture and piloerection. There were frequent instances of noisy respiration and red/brown staining around the head. The majority of animals showed good signs of recovery over the recovery period, one animal exhibited a scab on the head on Days 8 and 9 but this was not considered to be treatment related. Female animals recovered quicker than male animals such that they appeared normal from Days 3 to 8 post-exposure. Three out of the four surviving male animals appeared normal from Days 5 to 12, however, one male animal still exhibited noisy respiration by Day 14.
All male animals exhibited bodyweight loss or reduced bodyweight gain during Week 1, four of these animals recovered to show normal development during Week 2. Normal bodyweight development was noted for all female animals during the study.
Apart from one instance of dark patches on the lungs no macroscopic abnormalities were detected amongst animals that survived until Day 14 at necropsy.
The 4 h LC50 was 5.13 mg/L air.
Dermal toxicity
In an acute dermal toxicity study according to OECD TG 402, Sprague-Dawley rats (5/sex/dose) were dermally exposed to 2000 mg/kg bw 3,3'-Thiobispropanoic acid in water for 24 h under semiocclusive conditions. Animals were then observed for 14 d.
No mortality occurred during the study. No signs of systemic toxicity were observed. All animals showed the expected gains in bodyweight over the study period.
The dermal LD50 was >2000 mg/kg bw.
Justification for classification or non-classification
Based on the available data, 3,3'-Thiobispropanoic acid does not need to be classified for acute toxicity via the oral, inhalation, or dermal route according to regulation (EC) 1272/2008. Thus, no labelling is required.
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