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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 225-691-8 | CAS number: 5012-29-3
- 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:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide
- EC Number:
- 220-509-3
- EC Name:
- 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide
- Cas Number:
- 2786-76-7
- Molecular formula:
- C26H22N4O4
- IUPAC Name:
- 4-[(4-carbamoylphenyl)diazenyl]-N-(2-ethoxyphenyl)-3-hydroxy-2-naphthamide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: DEB2 152781 (Mi. 4014/2011)
- Expiration date of the lot/batch: 2021-06-12
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility and stability of the test substance in the solvent/vehicle:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Final preparation of a solid: moistened solid
FORM AS APPLIED IN THE TEST : solid
Purity: 98,2 % w/w
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species/strain: healthy rats, WISTAR rats Cd: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 8 - 9 weeks old females: 11 - 12 weeks old
Body weight on the day of administration: males: 227 - 245 g;females: 207 - 218 g.
The female animals were non-pregnant and nulliparous.
The animals were derived from a controlled full-barrier maintained breeding system
(SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare [6) the
animals were bred for experimental purposes.
Full barrier in an air-conditioned room
Temperature: 22 ± 3 °C
Relative humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: lOx / hour
Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1114)
Free access to tap water, sulphur acidified to a pH value of approximately 2.8
(drinking water, municipal residue control, microbiological controls at regular
intervals)
The animals were kept individually in IVC cages, type III H, polysulphone cages on
Altromin saw fibre bedding (lot no. 110811)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- test item was moistened, not suspended or dissolved
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsum
- % coverage: 10
- Type of wrap if used: gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): once usinsg cotton seed oil
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kb bw
- Concentration (if solution): n.a.
- Constant concentration used: yes
- For solids, paste formed: yes
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kbg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- No effects
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The dermal LD50 was determined to be > 2000 mg / kg body weight.
- Executive summary:
LD50: > 2000 mg /kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle (moistening): cottonseed oil
Number of animals: 5 male and 5 female
Duration of exposure: 24 hours
Method: OECD 402; EC 440/2008, Method B.3; OPPTS 870.1200
Table 1: Results per Step
Sex Dose (mg/kg bw) Number of animals Deaths male 2000 5 0 female 2000 5 0 Signs of toxicity related to dose level used, time of onset and duration:
No treatment-related effects were observed
Effect on organs (related to dose level):
No treatment-related effects were observed.
Signs of irritation:
No erythema or oedema was observed, scratches were observed in 1 of 5 male animals.
Conclusion
Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated
with neither mortality nor signs of toxicity. In one male animal scratches were observed from day 6 until the end of the observation period.
The dermal LD50 was determined to be > 2000 mg/ kg body weight.
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.