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EC number: 204-482-5 | CAS number: 121-57-3
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD test guideline 402 under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- relative humidity was slightly out of range on two days with no effects on the results
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Sulphanilic acid
- EC Number:
- 204-482-5
- EC Name:
- Sulphanilic acid
- Cas Number:
- 121-57-3
- Molecular formula:
- C6H7NO3S
- IUPAC Name:
- 4-aminobenzene-1-sulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): Sulfanilic Acid (sieved)
- Physical state: grey powder
- Analytical purity: > 98.5%
- Lot/batch No.: M 002/10
- Expiration date of the lot/batch: May 2012
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle — France)
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 206-241 g
- Fasting period before study: no
- Housing: individual during treatment; by 2 or 3 from day 2 onwards
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 °C
- Humidity (%): 40 -74 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping. At least 10 per cent of the body surface area was clear for the application of the test item.
Animals from treated group received, by topical application under porous gauze dressing, an effective dose of 2000 mg/kg body weight:
4 g or 2 g of the test item was weighed and liquid paraffin was added in a 20 mL or 10 mL volumetric glass flask, respectively.
The preparation was manually stirred to obtain a homogeneous grey to green suspension.
The preparation was administered under a volume of 10 mL/kg body weight during 24 hours. - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Systematic examinations were carried out daily to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item.
The animals were weighed on day DO (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: yes (macroscopic observations) - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no effects
- Other findings:
- - erythema and dryness on the treatment site were observed for two females (days 2 to 5)
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a study according to OECD test guideline 402 under GLP, the dermal LD50 of the test substance was determined to be > 2000 mg/kg bw.
- Executive summary:
The test substance was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No 402 dated February 24th, 1987. No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed. An erythema, associated with dryness, was noted on the treatment site of two females on day 2 and of all females between day 3 and day 5. The body weight development of the animals remained comparable between treated and control animals throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test substance is higher than 2000 mg/kg body weight by dermal route in the rat.
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