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EC number: 249-881-5 | CAS number: 29820-13-1
- 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
- Study period:
- 05 Mar 2003 - 10 July 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ex vivo study
- Principles of method if other than guideline:
- The rabbit enucleated eye test is used at SPL as a first stage in the assessment of ocular irritancy potential. The preferred species of choice is the rabbit. The assay has undergone interlaboratory validation and has been shown to reliably detect test materials that are negligible, or moderate to severe ocular irritants compared to the OECD 405 guideline study.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Dept. of Health, UK
Test material
- Reference substance name:
- CaTG
- IUPAC Name:
- CaTG
- Reference substance name:
- Calcium sulphidoacetate
- EC Number:
- 249-881-5
- EC Name:
- Calcium sulphidoacetate
- Cas Number:
- 29820-13-1
- Molecular formula:
- C2H4O2S.Ca x 3 H2O
- IUPAC Name:
- calcium 2-sulfanidylacetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: white powder
-The pH of the test item at the concentration of 10% in purified water was 12.2 (SPL).
- Analytical purity: 99.8%
- Lot/batch No.: 4486
- Storage condition of test material: at room temperature, in the dark and under nitrogen gas.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: ex vivo rabbit eyes
- Strain:
- not specified
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A volume of 0.1 ml of the test material, which was found to weigh approximately 55 mg (as measured by gently compacting the required volume into an adapted syringe) was sprinkled as evenly as possible over the surface of the cornea. After ten seconds the test material was washed off the cornea using a minimum of 20 ml of saline solution (approximately 32°C). After washing, some of the test material was found to have adhered to the cornea, this did not affect the assessment of irritation or swelling.
- Duration of treatment / exposure:
- Immediately following washing of the corneal surface, the treated eye was returned to the superfusion chamber and the saline drip repositioned to irrigate the eye. The untreated eyes were similarly washed and used for control purposes.
- Observation period (in vivo):
- Assessment of corneal cloudiness was made pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment, according to the numerical evaluation adopted from Advances in Modern Toxicology: Dermatoxicology, 4th Ed, (F Marzulli and H Maibach, eds) Hemisphere Publishing Corporation, Washington DC, 1991, pp 749-815.
- Number of animals or in vitro replicates:
- Three eyes were treated with test material, two additional eyes remained untreated for control purposes. The treatment eye was removed from thesuperfusion apparatus whilst still being held in the perspex clamp. The clamp/eye was then placed horizontally into a petri dish.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Irritation parameter:
- other: Corneal Epithelium Condition
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Other effects / acceptance of results:
- Corneal Opacity: No corneal effects were noted in the test eyes or control eyes during the study period.
Corneal thickness and Condition: Corneal swelling of the test eyes during the study period was slightly greater than that observed in the control eyes over the same period. The condition of the corneal epithelium of the test eyes and control eyes appeared normal during the study period.
Fluorescein Uptake: No fluorescein uptake was noted in the test eyes or control eyes 240 minutes after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of the test and following assessment of data for all end points, the test material is considered to have the potential to cause ocular irritancy in vivo. The test material is also likely to cause severe ocular irritancy in vivo in respect of its extreme alkalinity in aqueous solution.
- Executive summary:
A screening study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man.
For that purpose 0.1 ml of the test material, which was found to weigh approximately 55 mg, was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32°C ± 1.5°C within a superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).
Maximal ocular irritation observations recorded for the test eyes were as follows:
Corneal Opacity
Fluorescein Uptake
Corneal Swelling (%)
Condition of Corneal Epithelium
Test Eyes a [min]
Control Eyes b [min]
Cldy
Area
Int
Area
60
120
240
60
120
240
0
0
0
0
11.2
12.5
20.0
3.4
3.6
3.7
Normal
a = For each time point the swelling recorded is the mean of three eyes
b = For each time point the swelling recorded is the mean of two eyes
Cldy = Corneal cloudiness
Int = Intensity of fluorescein uptake
[min] = Minutes following treatment
It can be concluded that under the conditions of the test, the test material is considered to have the potential to cause ocular irritancy in-vivo. The test material is also likely to cause severe ocular irritancy in-vivo in respect of its extreme alkalinity in aqueous solution.
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