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Diss Factsheets
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EC number: 928-472-1 | CAS number: 1184301-52-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.05.2004 - 28.06.2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate
- EC Number:
- 928-472-1
- Cas Number:
- 1184301-52-7
- Molecular formula:
- C11-H17-N3-O6-S x 3H2O
- IUPAC Name:
- (6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- In the study report is mentioned that a dihydrate was used for testing, this statement is not correct. After further evaluation of the substances it was found out that it is a trihydrate. The batch for testing was a typical production batch.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Male New Zealand whit rabbits were obtained from Ferenc Sandor Breeder
- The rabbits were in a body weight range of 2813g - 3487g at the beginning of the study
- The young adult rabbits were less than 11 weeks old at arrival
CONDITIONS
- The animals were housed individually in metal cages designed to permit 8-12 air exchange/hour by central air-condition system. The target temperature and relative humidity ranges were 20 +/- 3 degree Celsius and 30-70 %, respectively.
- Light cycle is 12 hours daily, from 6:00am - 6:00pm
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 0.5g of test item
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48 and 72h
- Number of animals:
- 3 male
- Details on study design:
- Three male animals in acceptable health condition were used for the test as certified by the veterinarian. Each animal was examined 24 hours before starting the test. Animals showing any dermal defects or pre-existing dermal injury were not used.
Patch testing was used to detect primary irritating effects of the test item. 0.5g of the test item was applied in substantia to the skin of the experimental animals. The test item was moistened sufficiently with water to ensure good contact with skin. The test item was applied as a single dose. Sterile gauze pads were placed on the skin of the rabbits. These gauzes were kept in contact with the skin by a patch with surrounding adhesive hypoallergenic plaster. The entire trunk of the animals was wrapped with plastic wrap for 4 hours.
At the end of the observation period all animals were sacrificed under carbon dioxide anaesthesia.
The animals were observed for 72 hours, the duration of the study was sufficient to evaluate fully the reversibility or irreversibility of the effects observed. The dermal irritation scores were evaluated according to the scoring system Draize (1959).
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. to CLP
- Conclusions:
- On the basis of the results of the present study the test item is Non irritant.
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