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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
Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- 3,3'-thiodi(propionic acid)
- EC Number:
- 203-841-3
- EC Name:
- 3,3'-thiodi(propionic acid)
- Cas Number:
- 111-17-1
- Molecular formula:
- C6H10O4S
- IUPAC Name:
- 3-[(2-carboxyethyl)sulfanyl]propanoic acid
- Details on test material:
- - Name of test material (as cited in study report): 3,3´-Thiobispropanoic acid
- Analytical purity: 99.5 %
- Lot/batch No.: NT-463
Constituent 1
Test animals / tissue source
- Species:
- other: rabbit eyes
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Enucleated eyes were used for the test.
Test system
- 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
Results and discussion
In vitro
Resultsopen allclose all
- 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
Any other information on results incl. tables
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 %
Applicant's summary and conclusion
- 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.
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