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EC number: 260-152-0 | CAS number: 56396-10-2
- 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
- Study period:
- The study was conducted between the 7 December 2001 and 21 December 2001.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide
- EC Number:
- 260-152-0
- EC Name:
- 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide
- Cas Number:
- 56396-10-2
- Molecular formula:
- C25H20N4O4
- IUPAC Name:
- 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide
- Test material form:
- solid: particulate/powder
- Remarks:
- (magenta)
- Details on test material:
- For all studies conducted on substance, where identifier was ST463, purity was stated as >98 - 99.9% (depending on batch)
Constituent 1
- Specific details on test material used for the study:
- Identity:: ST463
Appearance: Magenta powder
Storage conditions: Room temperature
Lot number: 6558
Purity: 99.9%
Sample received: October 2002
Expiry: 15 0ctober 2001
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan U.K.Ltd. Bicester,Oxon, Engiand
- Age at study initiation: 8-11 weeks old
- Weight at study initiation: 214-262 g
- Housing: The rats were allocated without concious bias to cages within the treatment group. They were housed individually in metal cages (RS Biotech Sub-Divisible Rodent Cages - polished stainless steel). The cages were fitted with grid floors to ensure rapid removal of waste material to undertrays. The cages were suspended in mobile stainless steel racks.
- Diet (e.g. ad libitum): Standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet) (ad libitum)
- Water (e.g. ad libitum): drinking water (ad libitum)
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12 hrs day/12 hrs night
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- Hair was removed from the dorso-lumbar region of each rat with electric clippers taking care to avoid damaging the skin,exposing an area equivalent to approxilnately 10% of the total body surface area.
The test substance was applied by spreading it evenly over the prepared skin. The treatnent area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non-iritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal. Treatment in this manner was performed on Day 1 (day of dosing) of the study only. - Duration of exposure:
- 24 hours - At the end of the 24 hours exposure period the dressing was carefully removed and the treated area of skin was washed mild detergent followed by warm water(30- 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5 animals per sex per dose (five males at 2000 mg/kg bodyweight and five females at 2000 mg/kg bodyweight)
- Control animals:
- no
- Details on study design:
- TEST SUBSTANCE PREPARATION:
The test item was formulated at a maximum practical concentration of 57% w/v in corn oil and administered at a dose volume of 3.51 ml/kg bodyweight.
The absorption of the test substance was not determined.
Characterisation of the homogeneity, stability and purity of the test substance was not undertaken in this studt and remained the responsibility of the Sponsor.
CONTROL ANIMALS:
No control animals were included in this study.
OBSERVATIONS:
Mortality:
Cages of rats were checked at least twice daily for mortalities.
Clinical signs:
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity of the clinical signs and time were recorded at each observations.
All animals were observed for 14 days after dosing.
Dermal responses:
Local dermal irritation at the treatment site was assessed daily using the following numerical scoring system:
Erythema and eschar formation:
No erythema = 0
Very slight erythema (barely perceptible) = 1
Well-defined erythema = 2
Moderate to severe erythema = 3
Severe erythema (beet redness) to eschar formation (injuries in depth) = 4
Oedema formation:
No oedema = 0
Very slight oedema (barely perceptible) = 1
Slight oedema (edges of area well-defined by definite raising) = 2
Moderate oedema (raised approximately 1 mm) = 3
Severe oedema (raise more than 1 mm and extending beyond the area of exposure) = 4
Any lesion or reaction not covered by this scoring system was described.
Bodyweight:
The bodyweight of each rat was recorded on Days 1(prior to dosing), 8 and 15 bodyweight changes and group mean bodyweights were calculated.
TERMINAL STUDIES
Termination:
All animals were killed on Day 15 by carbon dioxide asphyxiation.
Macroscopic pathology:
All animals were subjected to a macroscoplc examination which consisted of opening the thoracic and abdominal cavities. The macroscopic appearance of all tissues was recorded.
Deviations from protocol:
There were no deviations from the protocol.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single dermal application of the test item to a group of 10 rats (5 males and 5 females) at a dose level of 2000 mg/kg bodyweight.
- Clinical signs:
- other: Clinical signs were confined to dark cerise coloured faeces seen in all animals on Days 3 through 5. No other clinical signs of reaction to treatment were observed during the study.
- Gross pathology:
- Macroscopic examination revealed dark cerise staining at the dose site of 2 females. No other abnormalities were recorded at the macroscopic examination at study termination on Day 15.
- Other findings:
- Very slight dermal irritation (Grade l oedema) was observed in 1 male following removal of the dressings, resolving completely by Day 3. A residual cerise staining from the test material precluded assessment of erythema in all animals up to Day 11 or 13. In addition localised spots and/or scabbing was noted in 1 fernale on Day 9 and 10. No dermal irritation was observed in the remaining animals during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal dermal dose to rats of the test item was demonstrated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute dermal toxicity of the test item to the rat. The method followed was that described in:
- EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (Official Journal No. L383A, 29.12.92), Part B, Method B.3. Acute toxicity (dermal).
- OECD Guideline for Testing of Chemicals No. 402 "Acute Dermal Toxicity". Adopted: 24 February 1987.
A group of 10 rats (5 males and 5 females) received a single topical application of the test substance, formulated at a maximum practical concentration in corn oil, at a dose level of 2000 mg/kg bodyweight, for a duration of 24 hours. All animals were killed and examined macroscopically on Day 15, the end of the observation period.
Clinical signs were confined to dark cerise coloured faeces seen in all animals on Days 3 through 5. No other clinical signs of reaction to treatment were observed during the study.
Very slight dermal irritation (Grade 1 oedema) was observed in 1 male following removal of the dressings, resolving completely by Day 3. A redisual cerise staining from the test material precluded assessment of the erythema in all animals up to Day 11 or 13. In addition localised spots and/or scabbing was noted in 1 female on Day 9 and 10. No dermal irritation was observed in the remaining animals during the study.
Low bodyweight gains were noted in 1 male and 4 females on Day 8 (Nos. G2, G6, G7, G8 and G9) and for 3 females on Day 15 (Nos. G6, G7 and G9). All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.
Macroscopic examination revealed dark cerise staining at the dose site of 2 females. No other abnormalities were recorded at the macroscopic examination at study termination on Day 15.
The acute lethal dermal dose to rats of the test item was demonstrated to be greater than 2000 mg/kg bodyweight.
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