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main component 1 (isomer 1): 2-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonapht-7-ylamino]-1,3,5-triazin-2-ylamino}-3-{6-fluoro-4-[3-(1,5-disulfonaphth-2-ylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt;main component 1 (isomer 2): 2-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-3-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt;main component 2: 2,3-bis-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt;main component 3: 2,3-bis-{6-fluoro-4-[3-(1,5-disulfonaphth-2-ylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt
EC number: 422-610-1 | CAS number: -
- 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:
- 10 October 1996 to 14 November 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- See overall remarks attachment section
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 422-610-1
- EC Name:
- -
- Molecular formula:
- multi constituent
- IUPAC Name:
- tetracosasodium 2-[(1E)-2-[6-({4-[(1-{[4-({6-[(1E)-2-(2,5-disulfonatophenyl)diazen-1-yl]-5-hydroxy-7-sulfonatonaphthalen-2-yl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}propan-2-yl)amino]-6-fluoro-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonatonaphthalen-2-yl]diazen-1-yl]benzene-1,4-disulfonate 2-[(1E)-2-[6-({4-[(2-{[4-({6-[(1E)-2-(2,5-disulfonatophenyl)diazen-1-yl]-5-hydroxy-7-sulfonatonaphthalen-2-yl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}propyl)amino]-6-fluoro-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonatonaphthalen-2-yl]diazen-1-yl]naphthalene-1,5-disulfonate 3-[(1E)-2-[6-({4-[(1-{[4-({6-[(1E)-2-(4,8-disulfonatonaphthalen-2-yl)diazen-1-yl]-5-hydroxy-7-sulfonatonaphthalen-2-yl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}propan-2-yl)amino]-6-fluoro-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonatonaphthalen-2-yl]diazen-1-yl]naphthalene-1,5-disulfonate 5-[(1E)-2-[6-({4-[(2-{[4-({6-[(1E)-2-(2,5-disulfonatophenyl)diazen-1-yl]-5-hydroxy-7-sulfonatonaphthalen-2-yl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}propyl)amino]-6-fluoro-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonatonaphthalen-2-yl]diazen-1-yl]naphthalene-1,6-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- Identity: FAT 40557/A
Batch-no.: PV1
Purity: 65 %
Appearance: Solid powder, red-brown
Stability of Test Article: Stable under storage condition; expiration date: 30-SEP-2002
Stability of Test Article Dilution: Stable in polyethylene glycol for at least 48 hours
Expiration date: 30 September, 2002
Storage conditions: In the original container at room temperature away from direct sunlight
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at start of treatment: males: 8 weeks, females, 11 weeks
- Weight at start of treatment: males: 215.1 - 245.4 g, females: 200.5 - 209.1 g
- Housing: During acclimatization in groups of five in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz). During treatment and observation individually in Makrolon type-3 cages with standard softwood bedding.
- Diet: Pelleted standard Kliba 343, Batch 78/96 rat maintenance diet ("Kliba" Mühlen AG, CH-4303 Kaiseraugst), available ad libitum
- Water: Community water from Itingen, available ad libitum
- Acclimation period: One week under laboratory conditions, after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70 (values above 70 % during cleaning process possible)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Treatment: 10-0CT-1996 to 24-0CT-1996
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- Approximately 24 hours before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface. On test day 1, 4 mL at 2000 mg/kg bw test article was applied evenly on the skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Twenty-four hours after the application, the dressing was removed and the treated skin was washed with lukewarm tap water and dried with disposable paper towels and the skin reaction was assessed.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality / Viability: Four times during test day 1, and once daily during days 2-15, Body Weights: Test days 1 (pre-administration), 8 and 15, Symptoms: Each animal was examined for changes in appearance and behaviuor four times during day 1, and daily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (general behaviour, respiration, eye, nose, motility, body posture, motor susceptibility, skin), gross pathology - Statistics:
- Since no mortality was recorded, the LOGIT-Model could not be applied.
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:
- No deaths occured during the study.
- Clinical signs:
- other: All animals showed orange discoloration while scaling was observed in one male.
- Gross pathology:
- No macroscopic organ findings were observed in the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal median lethal dose (LD50) of FAT 40557/A was estimated to be >2000 mg/kg bw.
- Executive summary:
In a GLP-compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were administered the test substance (2000 mg/kg bw). The test substance was dissolved in polyethylene glycol and applied on the skin with a syringe and covered with a semi-occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14-day observation period followed. No mortality was observed during this period. Discoloration of the skin was observed in all animals while one male rat showed scaling. Slight loss of body weight was observed in three animals of which two recovered before the end of the observation period. No macroscopic findings were noted. Based on the study results, the dermal median lethal dose (LD50) of FAT 40557/A was estimated to be >2000 mg/kg bw.
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