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EC number: 225-862-7 | CAS number: 5124-25-4
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 6 July, 1993 to 13 July, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-anilino-3-nitro-N-phenylbenzenesulphonamide
- EC Number:
- 225-862-7
- EC Name:
- 4-anilino-3-nitro-N-phenylbenzenesulphonamide
- Cas Number:
- 5124-25-4
- Molecular formula:
- C18H15N3O4S
- IUPAC Name:
- 4-anilino-3-nitro-N-phenylbenzenesulfonamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Terasil gelb GWL roh feucht (FAT 36014/F)
- Physical state: Yellow-brown powder
- Analytical purity: 90.7%
- Batch No.: 292347.26
- Expiration date of the batch: April 01, 1998
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Lot/batch No.of test material: Terasil gelb GWL roh feucht (FAT 36014/F)
- Expiration date of the lot/batch: April 01, 1998
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test substance was ground to a powder using a mortar and pestle.The powdery test substance was applied with the aid of a patch. The patch was moistened with distilled water, immediately before application, to ensure close contact of the test substance to the animal's skin.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approx 12 weeks
- Weight at study initiation: 2374-2688 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/d.
- Water: Tap-water diluted with decalcified water, ad libitum
- Acclimation period: At least 5 d after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: Air-conditioned with 15 air changes/h
- Photoperiod: 12 h artificial fluorescent light/12 h dark
IN-LIFE DATES: From July 6, 1993 to July 13, 1993
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated flank of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Approx 10x15 cm²
- Type of wrap if used: The test substance was applied using a moistened Scotchpak-non-woven patch mounted on Micropore tape. The dressing was wrapped around the abdomen and secured with an elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Removed at the end of the exposure period using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Following exposure a yellow staining of the treated skin-area was noted after removal of the test substance minutes/hours/days after application.
75 minutes, 24 hours, 48 hours, 72 hours, 7 days
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema was observed in all three animals. The erythema had resolved within 72 h in one animal and within 7 days in other animals. Oedema was not observed in any of the animals during the observation period. Yellow staining of the treated skin by the test substance was observed in the three animals during the study. The body weights and variability in body weight gain of the animals were considered to be normal. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
- Other effects:
- Except for yellow staining of the treated skin in all three animals, there were no signs of corrosion, body weight variability, toxicity or mortality in any animal during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 36014/F is not irritating to the skin.
- Executive summary:
A study was conducted to evaluate the skin irritation potential of the test substance (of 90.7 % purity) in New Zealand White rabbits according to OECD Guideline 404 and EU Method B.4 in compliance with GLP. 500 mg of test substance was applied to a shaved skin area of 10 cm x 15 cm on one flank of each animal under a moistened 2 cm x 3 cm patch. The patch was held in contact with the skin for 4 h. Animals were scored for irritation reactions after 75 minutes, 24, 48 and 72 h, and then 7 d. Animals were monitored daily for viability, mortality and clinical signs. Body weights were recorded pre-test and at study termination. Very slight erythema was observed in all three animals. The erythema had resolved within 72 h in one animal and within 7 days in other animals. Oedema was not observed in any of the animals during the observation period. Yellow staining of the treated skin by the test substance was observed in the three animals during the study. This staining was found to have been reversed by 72 hours in two animals, however it was still present in one animal by the end of observation period of 7 days. The body weights and variability in body weight gain of the animals were considered to be normal. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Based on the above findings, the scores obtained does not meet the classification criteria as set by the Regulation (EC) No. 1272/2008. Hence, the test substance was considered to be not irritating to the skin.
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