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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
skin irritation: not irritating (OECD TG 404)
eye irritation: irreversible damage (REET)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- - Name of test material (as cited in study report): 3,3´-Thiobispropanoic acid
- Analytical purity: 99.5 %
- Lot/batch No.: NT-463 - GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: The animals were individually housed in supended cages.
- Diet (e.g. ad libitum) + Water (e.g. ad libitum): Free access to mains drinking water and food
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°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
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 0.5 g of test material moistened with 0.5 ml of distilled water. - Duration of treatment / exposure:
- one patch was removed at each time of three time points: 3 minutes, 1 hour and 4 hours after application.
- Observation period:
- One hour following the removal of the patches, and 24, 48 and 72 hours later, the test sides were examined for evidance of primary irritation.
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: shorn skin
- % coverage: 2.5*2.5 cm
- Type of wrap if used: a strip of surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
SCORING SYSTEM: Draize classification scheme - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not irritating to skin (OECD TG 404)
- Executive summary:
In a primary dermal irritation study according to OECD Guideline 404 (July 17, 1992), 3 young adult New Zealand white rabbits were dermally exposed to 0.5 g of 3,3´-Thiobispropanoic acid moistened with 0.5 ml of distilled water to 2.5 x 2.5 cm² skin surface for 3 minutes, 1 hour and 4 hours under semiocclusive conditions. Animals then were observed for 72 h. Irritation was scored by the method of Draize.
After 3 min and 1 hour exposure erythema and edema scores were 0 at all observations. After 4 h exposure very slight erythema (grade 1) was present in all tree animals, and very slight edema (grade 1) in 1/3 animals. These effects were reversible within 24 h. No other signs of irritation were observed during the study.
In this study 3,3´-Thiobispropanoic acid is classified as not irritating to rabbit skin according the criteria of CLP, EU GHS (Regulation (EC) No 1272/2008).
Reference
Individual Skin reaktions (3 minutes and 1 hour):
Skin Reaction |
Observation Time |
Individual scores- Rabbit Number and Sex |
|||
65966 Male |
|||||
3-minutes exposure |
1 hour exposure |
||||
Erythema/Eschar Formation |
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
|
Odema formation |
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
Individual skin reaktion (4 -hour exposure):
Skin Reaction |
Observation Time |
Individual scores- Rabbit Number and Sex |
||
|
||||
65966 male |
65983 male |
65985 male |
||
Erythema/Eschar Formation |
1 hour 24 hours 48 hours 72 hours |
1 0 0 0 |
1 0 0 0 |
1 0 0 0 |
Odema formation |
1 hour 24 hours 48 hours 72 hours |
1 0 0 0 |
0 0 0 0 |
0 0 0 0 |
Sum of 24 and 72 hour readings: 0 |
||||
Primary Irritation Index 8S/6): 0/6 = 0.0 |
||||
Classification: NON IRRITANT |
The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study with acceptable restrictions Rabbit eyes tested
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: ICCVAM-Recommended Test Method Protocol Isolated Rabbit Eye Test Method
- Deviations:
- yes
- Remarks:
- no positive control, no fluorescein retention tested
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: rabbit eyes
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Enucleated eyes were used for the test.
- Vehicle:
- physiological saline
- Controls:
- other: control eyes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test material (ca. 79 g) - Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- 60, 120, 180 and 240 minutes following treatment
- Number of animals or in vitro replicates:
- Three eyes were treated with test material, two additional eyes remained untreated for control purposes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 10 seconds the test material was washed off the cornea using a minimum of 20 mL of saline solution.
The untreated eyes were similarly washed and used for control
SCORING SYSTEM: REET parameters
TOOL USED TO ASSESS SCORE: slit lamp-biomicroscope - Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 1 h observation
- Value:
- 15.1
- Negative controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 2 h observation
- Value:
- 18.1
- Negative controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 4 h observation
- Value:
- 21.8
- Negative controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Remarks:
- Corneal Opacity x Area
- Run / experiment:
- 1 h observation
- Value:
- 0
- Negative controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Remarks:
- Corneal Opacity x Area
- Run / experiment:
- 2, 3, 4 h observation
- Value:
- 2
- Negative controls validity:
- valid
- Irritation parameter:
- morphological effects
- Run / experiment:
- 3, 4 h observation
- Negative controls validity:
- valid
- Remarks on result:
- other: Sloughing
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Executive summary:
For the assessment of the eye irritation potential of 3,3´-Thiobispropanoic acid data from an Isolated Rabbit Eye Test (REET) are available.
Three enucleated rabbit eyes were exposed to a single application of 0.1 mL test sample for 10 seconds followed by a 20 mL saline rinse. Two untreated eyes were similarly washed and used as control. Observations were made 60, 120, 180 and 240 minutes following treatment.
Some loss of transparency was noted in the test eyes during the study (opacity score 1, area score 2). No corneal effects were noted in the control eyes during the study. Corneal swelling of the test eyes was greater than observed in the control eyes over the same period. Sloughing was noted in all test eyes. Control eyes were normal. Based on the morphological effects (sloughing) the test material was considered to have the potential to cause severe ocular damage.
Reference
Rabbit enucleated eye test- Individual scores for Corneal Opacity:
|
Test eye |
Control Eye |
||||||||||||||||||
Chamber number |
1 |
2 |
3 |
1 |
2 |
|||||||||||||||
Time after treatmen (Minutes) |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
Degree of Corneal Opacity |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Corneal Opacity |
0 |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Some loss of transparency was noted in the test eyes during the study. No corneal effect were noted in the control eyes during the study.
Rabbit enucleated eye test- Individual measurements for Corneal thickness (µm):
Test eye |
|||||||||||||||||||||||||
Time after treatment (minutes) |
60 |
120 |
180 |
240 |
|||||||||||||||||||||
Corneal position |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
|
Chamber number |
1 |
401 |
398 |
395 |
406 |
400 |
400 |
421 |
416 |
416 |
420 |
422 |
419 |
425 |
433 |
434 |
444 |
442 |
435.6 |
444 |
443 |
424 |
430 |
440 |
436.2 |
2 |
437 |
445 |
436 |
439 |
425 |
436.4 |
461 |
447 |
446 |
444 |
443 |
448.2 |
484 |
475 |
476 |
479 |
480 |
478.8 |
463 |
461 |
458 |
438 |
462 |
456.4 |
|
3 |
413 |
403 |
410 |
410 |
430 |
413.2 |
422 |
402 |
410 |
411 |
432 |
415.4 |
445 |
418 |
415 |
414 |
439 |
426.2 |
438 |
420 |
418 |
422 |
448 |
429.2 |
Control Eyes |
|||||||||||||||||||||||||
Time after treatment (minutes) |
60 |
120 |
180 |
240 |
|||||||||||||||||||||
Corneal position |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
|
Chamber number |
1 |
395 |
373 |
375 |
381 |
386 |
382 |
385 |
371 |
364 |
372 |
374 |
373.2 |
383 |
365 |
364 |
370 |
368 |
370 |
388 |
362 |
362 |
371 |
377 |
372 |
2 |
427 |
399 |
396 |
413 |
410 |
409 |
385 |
395 |
387 |
400 |
401 |
393.6 |
403 |
388 |
389 |
392 |
396 |
393.6 |
398 |
383 |
392 |
402 |
394 |
393.8 |
Corneal swelling of the test eyes was greater than observed in the control eyes over the same period.
Sloughing was noted in all test eyes . Control eyes were normal.
Rabbit enucleated eye test-Corneal Epithelium condition:
Test Eyes |
||||||
Time after treatment (minutes) |
60 |
120 |
180 |
240 |
||
Chamber number |
1 |
normal |
normal |
Sloughing |
Sloughing |
|
2 |
normal |
normal |
Sloughing |
Sloughing |
||
3 |
normal |
normal |
normal |
Sloughing |
Control Eyes |
||||||
Time after treatment (minutes) |
60 |
120 |
180 |
240 |
||
Chamber number |
1 |
normal |
normal |
normal |
normal |
|
2 |
normal |
normal |
normal |
normal |
Rabbit enucleated eye test- Determination of corneal swelling:
Test Eye:
Mean corneal swelling 1 hour following treatment: 15.1 %
Mean corneal swelling 2 hours following treatment: 18.1 %
Mean corneal swelling 4 hours following treatment: 21.8 %
Control Eye:
Mean corneal swelling 1 hour following treatment: 9.9 %
Mean corneal swelling 2 hours following treatment: 6.5 %
Mean corneal swelling 4 hours following treatment: 6.4 %
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
In a primary dermal irritation study according to OECD Guideline 404 (July 17, 1992), 3 young adult New Zealand white rabbits were dermally exposed to 0.5 g of 3,3´-Thiobispropanoic acid moistened with 0.5 ml of distilled water to 2.5 x 2.5 cm² skin surface for 3 minutes, 1 hour and 4 hours under semiocclusive conditions. Animals then were observed for 72 h. Irritation was scored by the method of Draize.
After 3 min and 1 hour exposure erythema and edema scores were 0 at all observations. After 4 h exposure very slight erythema (grade 1) was present in all tree animals, and very slight edema (grade 1) in 1/3 animals. These effects were reversible within 24 h. No other signs of irritation were observed during the study.
In this study 3,3´-Thiobispropanoic acid is classified as not irritating to rabbit skin according the criteria of CLP, EU GHS (Regulation (EC) No 1272/2008).
Eye irritation
For the assessment of the eye irritation potential of 3,3´-Thiobispropanoic acid data from an Isolated Rabbit Eye Test (REET) are available.
Three enucleated rabbit eyes were exposed to a single application of 0.1 mL test sample for 10 seconds followed by a 20 mL saline rinse. Two untreated eyes were similarly washed and used as control. Observations were made 60, 120, 180 and 240 minutes following treatment.
Some loss of transparency was noted in the test eyes during the study (score 1, area score 2). No corneal effects were noted in the control eyes during the study. Corneal swelling of the test eyes was greater than observed in the control eyes over the same period. Sloughing was noted in all test eyes. Control eyes were normal. Based on the morphological effects (sloughing) the test material was considered to have the potential to cause severe ocular damage.
Respiratory irritation
No data on the respiratory irritation of 3,3´-Thiobispropanoic acid are available.
There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.
Justification for classification or non-classification
Skin irritation
Based on reliable, adequate and relevant data, 3,3´-Thiobispropanoic acid does not need to be classifiedfor skin irritation according to regulation (EC) 1272/2008.
Eye irritation
Based on reliable, adequate and relevant data, 3,3´-Thiobispropanoic acid has to be classified as Category 1, irreversible effects on the eye according to CLP, EU GHS (Regulation (EC) No 1272/2008) and is assigned the hazard statement H318 and the signal word “Danger”.
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