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EC number: 265-529-3 | CAS number: 65151-26-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- limited documentation regarding composition of test material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to the Swiss Ordinance relating to GLP [RS 813.016.5]
Test material
- Reference substance name:
- Disodium 7-[(4-amino-3-methoxyphenyl)azo]naphthalene-1,3-disulphonate
- EC Number:
- 265-529-3
- EC Name:
- Disodium 7-[(4-amino-3-methoxyphenyl)azo]naphthalene-1,3-disulphonate
- Cas Number:
- 65151-26-0
- Molecular formula:
- C17H15N3O7S2.2Na
- IUPAC Name:
- disodium 7-[(4-amino-3-methoxyphenyl)diazenyl]naphthalene-1,3-disulfonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test item/per animal - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after administration
- Number of animals:
- 3 (2 males, 1 female)
- Details on study design:
- SCORING SYSTEM: Draize J H (1959) "Dermal Toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Drug Officials of the US, Austin, Texas p47
- Method of calculation: mean of the 24, 48, 72 reading, separately for each rabbit and each type of skin reaction.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal:
- Remarks:
- # 71, 72, 74 each
- Time point:
- other: mean of the 24-48-72 h reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable since no signs of irritation (edema) at any time
- Irritation parameter:
- erythema score
- Basis:
- animal:
- Remarks:
- # 71, 72, 74 each
- Time point:
- other: mean of the 24-48-72 h reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable since no signs of irritation (erythema) at any time
- Remarks on result:
- other: dark orange coloured staining produced by the test item
- Irritant / corrosive response data:
- no signs of irritation were observed at any time
- Other effects:
- The test item caused a marked dark orange staining at the test site of all animals
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not irritating
- Conclusions:
- The test substance has not to be classified according regulation (EU) 1272/2008, Annex I, 3.2.
- Executive summary:
The test material was subject to an acute dermal irritation/corrosion test in 3 New Zealand White rabbits (2 males, 1 female) according to OECD TG 404. A single 4-hour semi-occluded application (0.5 g) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration. No skin reactions occurred during the observation period.
The mean score for oedema and erythema grades was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal separately. The mean score for oedema and erythema was 0 for all three animals. The application of the test item to the skin resulted in marked dark orange staining produced by the color of test item of the treated skin in all animals at the 1- hour reading and persisted in all animals up to the end of the observation period. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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