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Reaction mass of pentasodium 2-{[4-chloro-6-(ethyl{3-[(2-sulfonatoethyl)sulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}-5-hydroxy-6-({2-sulfonato-4-[(4-sulfonatophenyl)diazenyl]phenyl}diazenyl)naphthalene-1,7-disulfonate and tetrasodium 2-[(4-chloro-6-{ethyl[3-(vinylsulfonyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]-5-hydroxy-6-({2-sulfonato-4-[(4-sulfonatophenyl)diazenyl]phenyl}diazenyl)naphthalene-1,7-disulfonate
EC number: 459-580-2 | 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
Endpoint summary
Administrative data
Description of key information
The acute median lethal dose ( LD50) of test substance in the acute oral and dermal toxicity study was >2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 December 2005 to 03 Febuary 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Identity: FAT 40824/A
Batch: Red ROE 805 BOP 04/05
Appearance: dark red powder
Purity: Organic part (Na-salt): approx. 82 %; Main component 1 : approx. 36.2 %; Main component 2: approx. 27.5 %; Oligomers: 10%
Expiration date: 01 October 2010
Stability in water: Max. 7 days at room temperature
Storage: At room temperature at about 20 °C, in a desiccator because test substance is hygroscopic, away from direct sunlight - Species:
- rat
- Strain:
- other: Rat, HanRcc:WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: 12-13 weeks
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet: Pelleted standard Provimi Kliba 3433 rat/moitse maintenance diet, batch no. 63/05 ad libitum.
- Water: Community tap water from Fiillinsdorf ad libitum.
- Fasting period before study: 18-19 hours
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour.
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The dose formulations were made shortly before each dosing occasion using a magnetic stirrer and a spatula as homogenizers.The test item was weighed into a tared glass beaker on a surtable precision balance and the vehicle added (weight/volume). Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 females per group and two groups per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights. - Statistics:
- No statistical analysis was used.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed at highest dose group tested (2000 mg/kg bw)
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: Slightly ruffled fur was observed in two of 6 animals from the 2- to 3- hour reading. Dark red feces were noted in both cages on test 2 and 3.
- Gross pathology:
- No macroscopic findlings were recorded at necropsy.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose ( LD50) of FAT 40824/A to female rat was greater than 2000 mg/kg bw.
- Executive summary:
In a GLP compliant acute toxicity study conducted according to OECD TG 423, two groups, each of three female Wistar rats, were treated with FAT 40824/A by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/mL and administered at a volume dosage of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period. Slightly ruffled fur was observed in two out 6 animals from the 2- to the 3-hour reading. Dark red feces were noted in both cages on test day 2 and 3.
The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.
The median lethal dose of FAT 40824/A after single oral administration to female rats, observed over a period of 14 days (LD50) is greater than 2000 mg/kg body weight
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP compliant and guideline study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 December 2005 to 03 Febuary 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Identity: FAT 40824/A
Batch: Red ROE 805 BOP 04/05
Appearance: dark red powder
Purity: Organic part (Na-salt): approx. 82 %; Main component 1 : approx. 36.2 %; Main component 2: approx. 27.5 %; Oligomers: 10%
Expiration date: 01 October 2010
Stability in water: Max. 7 days at room temperature
Storage: At room temperature at about 20 °C, in a desiccator because test substance is hygroscopic, away from direct sunlight - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland.
- Age at study initiation: 12-13 weeks for females; 8-9 weeks for males.
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding.
- Diet:: Pelleted standard Provimi Kliba 3433 rat/moitse maintenance diet, batch no. 63/05 ad libitum.
- Water: Community tap water from Fiillinsdorf ad libitum.
- Fasting period before study: 18-19 hours
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 30-70
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour.
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period. - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: backs
- % coverage: 10% od the total body surface
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6mL - Duration of exposure:
- 24h
- 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: All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights and local signs. - Statistics:
- No statistics analysis was used.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality at highest dose group (2000 mg/kg bw)
- Mortality:
- No deaths occurred during the study
- Clinical signs:
- other: No systemic signs of toxicity were observed during the study period. A possible erythemateous reaction could not be assessed due lo a red discoloration produced by the test item in all male and all female animals from test day 2 to test day 5, 6, 7, 8 or
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) to rat was greater than 2000 mg/kg bw.
- Executive summary:
In a GLP compliant acute toxicity study conducted according to OECD TG 402,Wistar rats (5/sex) were treated with FAT 40824/A at 2000 mg/kg by dermal application. The test item was diluted in vehicle (purified water) at a concentration of 0.33 g/mL and administered at a volume dosage of 6 ml/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
No deaths occurred during the study. No clinical signs were observed throughout the whole observation period. A possible erythemateous reaction could not be assessed due to a red discoloration produced by the test item in all male and all female animals from test day 2 to test day 5, 6, 7, 8 or 13. Slight crusts were noted in one female from test day 8 to 10. The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were observed at necropsy.
Based on the study results, the acute dermal median lethal dose (LD50) of FAT 40824/A to rat was greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP compliant and guideline study
Additional information
Acute oral toxicity:
In a GLP compliant acute toxicity study conducted according to OECD TG 423, two groups, each of three female Wistar rats, were treated with FAT 40824/A by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/mL and administered at a volume dosage of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded.
All animals survived until the end of the study period. Slightly ruffled fur was observed in two out 6 animals from the 2- to the 3-hour reading. Dark red feces were noted in both cages on test day 2 and 3. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.
The acute median lethal dose of FAT 40824/A after single oral administration to female rats, observed over a period of 14 days (LD50) is greater than 2000 mg/kg body weight.
Acute inhalation toxicity:
Currently no study to assess acute inhalation toxicity of Reactive Red 282 is available. However, with the low vapour pressure (1.8 x 10-29 Pa) and the high melting point (>400°C), the substance is considered to have low volatility. Synthesis and formulation of this chemical is performed in a closed process; the final product consists of liquid formulations only. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as a liquid formulation, the exposure via inhalation is unlikely. Further, Reactive Red 282 was found to be miscible in water (water solubility 373 g/L) and have low log partition coefficient (-5.8), hence in the case of dust of the substance entering the respiratory tract, it will be trapped in the mucus and cleared, thereby further limiting the absorption. The chemical showed low toxicity potential (LD50>2000 mg/kg bw) in the available acute oral and dermal toxicity studies with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure of Reactive Red 282 via inhalation routes and hence acute toxicity testing by the inhalation route was considered scientifically not necessary.
Acute dermal toxicity:
In a GLP compliant acute toxicity study conducted according to OECD TG 402,Wistar rats (5/sex) were treated with FAT 40824/A at 2000 mg/kg by dermal application. The test item was diluted in vehicle (purified water) at a concentration of 0.33 g/mL and administered at a volume dosage of 6 ml/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded.
No deaths occurred during the study. No clinical signs were observed throughout the whole observation period. A possible erythemateous reaction could not be assessed due to a red discoloration produced by the test item in all male and all female animals from test day 2 to test day 5, 6, 7, 8 or 13. Slight crusts were noted in one female from test day 8 to 10. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
Based on the study results, the acute dermal median lethal dose (LD50) of FAT 40824/A to rat was greater than 2000 mg/kg bw.
Justification for classification or non-classification
Based on the observed LD50of >2000 mg/kg bw in the acute oral and dermal toxicity study, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.
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