Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 303-156-0 | CAS number: 94158-82-4
- 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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer-revieded journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of the local lymph node assay with the guinea pig maximization test for the detection of a range of contact allergens
- Author:
- D.A. Basketter and E.W. Scholes
- Year:
- 1 992
- Bibliographic source:
- Fd. Chem. Toxic .Vol. 30, No 1, pp.65-69,1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Skin sensitization study of Sulfanilic Acid was performed in guinea pig by Guinea pig maximisation test
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- 4-amino benzenesulphonic acid
- Cas Number:
- 121-57-3
- Molecular formula:
- C6H7NO3S
- IUPAC Name:
- 4-amino benzenesulphonic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Sulfanilic acid
- Molecular formula :C6H7NO3S
- Molecular weight : 173.191 g/mole
- Smiles notation (if other than submission substance): S(c1ccc(N)cc1)(O)(=O)=O
- InChl (if other than submission substance): 1S/C6H7NO3S/c7-5-1-3-6(4-2-5)11(8,9)10/h1-4H,7H2, (H,8,9,10)
- Substance type: organic
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Sulfanilic acid
- Molecular formula :C6H7NO3S
- Molecular weight : 173.191 g/mole
- Smiles notation (if other than submission substance): S(c1ccc(N)cc1)(O)(=O)=O
- InChl (if other than submission substance): 1S/C6H7NO3S/c7-5-1-3-6(4-2-5)11(8,9)10/h1-4H,7H2, (H,8,9,10)
- Substance type: organic
- Physical state: solid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Albino
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation:350g
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: polyethylene glycol 400 / saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- 8
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: polyethylene glycol 400/ saline
- Concentration / amount:
- 5.0%
- No. of animals per dose:
- No data available
- Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:7
- Exposure period: 48hr
- Test groups: No data available
- Control group: No data available
- Site: shoulder region
- Frequency of applications: After 6-8 days epicutaneous application was carried out
- Duration: 8 days
- Concentrations: 5%
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 10-14 days
- Exposure period:24hr
- Test groups: No data available
- Control group: No data available
- Site: on one flank
- Concentrations:5%
- Evaluation (hr after challenge): 24 and 48hr - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- Clinical observations:
- 90% animals were observed positive for skin sensitizing reaction after challenge application.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- Clinical observations:
- 90% animals were observed positive for skin sensitizing reaction after challenge application.
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Sensitizing
- Conclusions:
- The Sulfanilic Acid (121-57-3) was considered to be skin sensitizing in guinea pig.
- Executive summary:
The skin sensitization study of Sulfanilic Acid (121-57-3) was performed by Guinea pig maximisation test. Albino Dunkin Hartley weighted approximately 350g were used. Preliminary irritation tests were carried out to determine the concentration of the test material suitable for induction and challenge of sensitization.
In induction phase, induction given using 5%, concentration in polyethylene glycol 400/saline by intradermal route for 6 times on shoulder region. After 6-8 day epicutaneous application was carried out using 5% concentration in same vehicle applied on same site for 48hr as occluded patch.
In challenge phase,10-14 days latter test substance in 5 % concentration in same vehicle was applied as occlusive patch on one flank for 24 hr. Challenge site were scored for erythema (Scale 0-3) and oedema 24 and 48 hr after removal of the patch. 90% animals were observed positive for skin sensitizing reaction after challenge application. Hence the Sulfanilic Acid (121-57-3) was considered to be skin sensitizing in guinea pig.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.