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EC number: 226-952-9 | CAS number: 5577-13-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: In vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP. Guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439: In vitro skin irritation
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 ("In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test")
- Principles of method if other than guideline:
- The test is based on the experience that irritant chemical show cytotoxic effects following short term exposure to the stratum corneum of the epidermis. The test is designed to predict and classify the skin irritation potencial of a test substance by assessment of its effect on a three dimensional human epidermis model.
The test consists of topical application of Tolfamato on the skin tissue for 15 minutes. After exposure the skin tissue is thoroughly rinsed to remove the test substance and transferred to fresh medium. After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect is performed. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl [(4-methylphenyl)sulphonyl]carbamate
- EC Number:
- 226-952-9
- EC Name:
- Ethyl [(4-methylphenyl)sulphonyl]carbamate
- Cas Number:
- 5577-13-9
- Molecular formula:
- C10H13NO4S
- IUPAC Name:
- ethyl [(4-methylphenyl)sulfonyl]carbamate
- Details on test material:
- Tolfamato was topically applied on a human three dimensional epidermal model.
Constituent 1
Test animals
- Species:
- other: human skin model
Test system
- Type of coverage:
- other: Its an in vitro test with no occlusive bandage as for in vivo test.
- Controls:
- yes
- Duration of treatment / exposure:
- 15 min
- Observation period:
- After exposure the skin tissue is thoroughly rinsed to remove the test substance and transferred to fresh medium.
After a 45 hour post-incubation period, determination of the cytotoxic (irritancy) effect is performed via MTT test. - Number of animals:
- No animals in this study but 3 tissue samples with control samples in parallel.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: OD570
- Basis:
- other: OD570
- Time point:
- other: 15 min
- Score:
- >= 0.818 - <= 0.863
- Max. score:
- 0.863
- Reversibility:
- no data
- Irritant / corrosive response data:
- Tolfamato was checked for possible direct MTT reduction by adding the test substance to MTT
medium. Because no colour change was observed it was concluded that Tolfamato did not interact
with MTT.
The mean absorption at 570 nm measured after treatment with Tolfamato and controls are presented
in Table 1. The individual OD570 measurements are presented in
Table 2 shows the mean tissue viability obtained after 15 minutes treatment with Tolfamato compared
to the negative control tissues. Skin irritation is expressed as the remaining cell viability after exposure
to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with
Tolfamato compared to the negative control tissues was 101%. Since the mean relative tissue viability
for Tolfamato was above 50% Tolfamato is considered to be non-irritant.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Tolfamato is non-irritant in the in vitro skin irritation test under the experimental conditions described.
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