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EC number: 233-915-0 | CAS number: 10433-41-7
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: Chinese standard HJ/T154-2004
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The in vivo skin sensitisation study was carried out before 10 May 2017, and meets the requirements set out in Article 13(3), first subparagraph, and Article 13(4) and is considered appropriate to address this standard information requirement.
Test material
- Reference substance name:
- Potassium dimethyl 5-sulphonatoisophthalate
- EC Number:
- 233-915-0
- EC Name:
- Potassium dimethyl 5-sulphonatoisophthalate
- Cas Number:
- 10433-41-7
- Molecular formula:
- C10H10O7S.K
- IUPAC Name:
- potassium 3,5-bis(methoxycarbonyl)benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot number of test material: manufacturer, 100315
In vivo test system
Test animals
- Species:
- guinea pig
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks old
- Weight at study initiation: 224 - 291 g
- Housing: 4 animals in a cage, in total 8 cages; plastic breed box (L35 x W50 x H32 cm), four in a cage, cage changed twice a week.
- Diet: During the whole period, the animals are free to eat.
- Water: During the whole period, the animals are free to drink.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 48 - 56
- Photoperiod (hrs dark / hrs light): 12/12, lighting simulates natural sunlight
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- Each test group has 16 animals: one negative control group and one experimental group.
- Details on study design:
- Induction contact:
Fur on one side of the back is shaved off 24 hr before testing, the area is 3 x 3 cm2.
0.2g of the sample is painted on a 2 x 2 cm2 filter paper, then placed on the exposed skin rinsed with distilled water, then cover with 2 layers of guaze fabric and a layer of oil paper, and fixed with non-irritating tape, in order to let the test sample to have good contact with the skin, and avoid animal licking. Treatment time is 6 hr.
Observe skin reaction at 1hr and 24 hr. Repeat the same method on the 7th and 14th day.
Challenge contact:
Fur on the other side of the animal is shaved off, the area is 3 x 3 cm2.
14 days after the last contact, 0.2g of the sample is painted on a 2 x 2 cm2 filter paper, and pasted on the exposed skin area with the same method for 6 hr. After removing the attached sample, record skin reaction everyday at 24hr, 48hr. Negative control and positive control are repeated with the same experimental method.
Use the number of animals with erythema or skin swelling at 24 hr, 48 hr and divide with the total number of animals, to calculate the sensitization ratio and categorise the sensitisation level and grade the acute skin sensitisation toxicity. - Positive control substance(s):
- yes
- Remarks:
- 0.5% 2,4-dinitrochlorobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g of the sample
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 g of the sample
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5% 2,4-dinitrochlorobenzene
- No. with + reactions:
- 16
- Total no. in group:
- 16
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5% 2,4-dinitrochlorobenzene
- No. with + reactions:
- 16
- Total no. in group:
- 16
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Using the Buehler test method, the guinea pigs treated with the test substance showed no skin sensitisation.
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