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EC number: 252-106-3 | CAS number: 34592-47-7
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2023
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (R)-thiazolidine-4-carboxylic acid
- EC Number:
- 252-106-3
- EC Name:
- (R)-thiazolidine-4-carboxylic acid
- Cas Number:
- 34592-47-7
- Molecular formula:
- C4H7NO2S
- IUPAC Name:
- (R)-thiazolidine-4-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Label name TCA
Batch number 20190104
Expiry date July 2024
Storage conditions Room temperature
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- treatment level of 30 µL/tissue unit
- Duration of treatment / exposure:
- 4 h followed by 30 minutes post-soak period
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- In the Main Assays, the test item was applied as supplied in two replicates at the treatment
level of 30 ±2 mg/tissue unit. - Details on study design:
- Before the Main Assay, a preliminary test was carried out to evaluate the compatibility of
the test item with the test system. In a first step, the test item was assayed for the ability of
reducing MTT per se. A white precipitate was noticed, but no colour change was observed
indicating that the test item did not directly interact with MTT. In a second step, the test item
was assayed for the ability of colouring water per se. A colourless solution was observed,
indicating that the test item has no potential interfering ability. Based on these results, no
additional controls were added in the Main Assay.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- Main assay I
- Value:
- 51
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Since a borderline value was obtained, it was necessary to perform a second Main Assay.
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- Main Assay II
- Value:
- 24
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Since discordant results were obtained in the first two Main Assays, a third assay was performed.
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- Main Assay III
- Value:
- 23
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- In Main Assay I the positive control caused the expected cell death (16% of cell viability
when compared to the negative control) and variability (difference of % viability equal to 1).
Based on the stated criteria (mean viability ≤ 20% and difference of cell viability between
each replicate lower than 20%), the assay was regarded as valid. The test item induced cell
death, the mean tissue viability after the blank subtraction was 51% when compared to the
negative control. Intra-replicate variability was acceptable with a difference of % viability
value equal to 1 (lower than 20, as stated in the Study Protocol). Since a borderline value
was obtained, it was necessary to perform a second Main Assay.
In the Main Assay II the positive control caused the expected cell death (4% of cell viability
when compared to the negative control) and variability (difference of % viability equal to 0).
Based on the stated criteria (mean viability ≤ 20% and difference of cell viability between
each replicate lower than 20%), the assay was regarded as valid. The test item induced cell
death, the mean tissue viability after the blank subtraction was 24% when compared to the
negative control. Intra-replicate variability was acceptable with a difference of % viability
value equal to 1 (lower than 20, as stated in the Study Protocol). Since discordant results
were obtained in the first two Main Assays, a third assay was performed.
In the Main Assay III the positive control caused the expected cell death (6% of cell viability
when compared to the negative control) and variability (difference of % viability equal to 0).
Based on the stated criteria (mean viability ≤ 20% and difference of cell viability between
each replicate lower than 20%), the assay was regarded as valid. The test item induced cell
death, the mean tissue viability after the blank subtraction was 23% when compared to the
negative control. Intra-replicate variability was acceptable with a difference of % viability
value equal to 1 (lower than 20, as stated in the Study Protocol).
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the results obtained, the test item L(-)-Thiazolidine-4-carboxylic acid (TCA) is
considered as irritant to the eye.
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