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EC number: 201-839-7 | CAS number: 88-53-9
- 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:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles. Conducted prior to implementation of OECD and GLP guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (§ 1500.41, Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- conducted prior to GLP guideline implementation
Test material
- Reference substance name:
- 5-amino-2-chlorotoluene-4-sulphonic acid
- EC Number:
- 201-839-7
- EC Name:
- 5-amino-2-chlorotoluene-4-sulphonic acid
- Cas Number:
- 88-53-9
- Molecular formula:
- C7H8ClNO3S
- IUPAC Name:
- 2-amino-5-chloro-4-methylbenzene-1-sulfonic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG breeding colony
- Strain: SPF-Albino-Himalayan, Hoe HIMK(SPFWiga)
- Weight at study initiation: 1,5 - 2,5 kg
- Housing: single cage
- Diet: ERKA 8300, ad libitum
- Water: tap water, ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped intact and clipped scarified
- Vehicle:
- other: 0.9% NaCl aqueous solution
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g mixed with 0.5 ml 0.9% NaCl aqueous solution
- Duration of treatment / exposure:
- 24h
- Observation period:
- 72 h after beginning of treatment
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #30
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant because of lacking effects
- Remarks on result:
- other: clipped intact
- Irritation parameter:
- erythema score
- Basis:
- animal: #36
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h after beginning of treatment
- Remarks on result:
- other: clipped intact
- Irritation parameter:
- erythema score
- Basis:
- animal: #37
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h after beginning of treatment
- Remarks on result:
- other: clipped intact
- Irritation parameter:
- erythema score
- Basis:
- animal: #38
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h after beginning of treatment (end of observation), but expected to be reversible within a prolonged observation period of 14 days.
- Remarks on result:
- other: clipped intact
- Irritation parameter:
- erythema score
- Basis:
- animal: #39
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h after beginning of treatment
- Remarks on result:
- other: clipped intact
- Irritation parameter:
- erythema score
- Basis:
- animal: #40
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h after beginning of treatment (end of observation), but expected to be reversible within a prolonged observation period of 14 days. Due to bad quality of the document the unreadable 72h score value was extrapolated by expert judgement.
- Remarks on result:
- other: clipped intact
- Irritation parameter:
- edema score
- Basis:
- animal: #30
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h after beginning of treatment
- Remarks on result:
- other: clipped intact
- Irritation parameter:
- edema score
- Basis:
- animal: #36 - #39 each
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant because of lacking effects
- Remarks on result:
- other: clipped intact
- Irritation parameter:
- edema score
- Basis:
- animal: #40
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h after beginning of treatment. Due to bad quality of the document the unreadable 72h score value was extrapolated by expert judgement.
- Remarks on result:
- other: clipped intact
- Irritant / corrosive response data:
- Based on the slightness and the full recovery in the majority of test animals a full reversibility of effects within 2 weeks is expected for the remaining ones.
Similar score values were obtained for clipped scarified skin.
Single animals showed temporarily scaled or chapped skin. Two animals formed scab which was not fully reversible within the observation period of 72 h. These effects were not assigned to the intact or scarified skin by the author of the report, but are assumed to be most likely associated with the scarified skin. - Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the test results the substance does not meet criteria for classification concerning skin cxorrosion/irritation as laid down in Regulation (EC) No 1272/2008.
This conclusion is legitimated even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill endpoint requirements. - Executive summary:
The test material was tested for skin irritancy according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance mixe with 0.5 ml of 0.9% NaCl aqueous solution for 24 h under occlusive conditions and the skin responses were examined at 24, 48, and 72 h after beginning of treatment. Mean values of the 24, 48 and 72 h readings were calculated for each animal. Only slight effects (erythema mean score: <=1, edema mean score: <= 0.3) below the threshold for classification were determined for the intact skin. All effects were fully reversible or expected to be fully reversible. Similar results were obtained for scarified skin. Based on these findings the test material was judged not to be irritating or corrosive to skin.
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