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EC number: 274-503-0 | CAS number: 70247-74-4
- 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
LD50 (oral) in rats is greater than 2000 mg/kg body weight.
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:
- 20 September 1995 - 26 October 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
9
- Expiration date of the lot/batch:
June 2000
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
In the original container at room temperature away from direct sunlight.
- Stability under test conditions:
Stable under stated storage condition;
expiration date: JUN-2000
- Stability of the test substance in the solvent/dispersant/vehicle/test medium:
Unknown in bi-distilled water, therefore is excluded from the statement of compliance. - 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 4414 Füllinsdorf / Switzerland
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 189.2 - 209.6 g; females: 173.6 - 185.2 g
- Housing:Groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet:Pelleted standard Kliba 343, Batch no. 65/95 rat maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to dosing). Results of analyses for contaminants are included in the report.
- Water: Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the report.
- Acclimation period: One week under laboratory conditions, after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 42-79
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.
In-life phase: 20-SEP-1995 to 04-0CT-1995 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:10 ml/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality - Statistics:
- The LOGIT-Model could not be used as no deaths occurred.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths as a result of treatment with the test article.
- Clinical signs:
- other: Diarrhoea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period.
- Gross pathology:
- No organ abnormalities were observed at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose (LD50) of FAT 20035/D in Wistar rats of both sexes is greater than 2000 mg/kg body weight.
- Executive summary:
The test article FAT 20035/D was administered to a group of 5 male and 5 female Wistar rats by oral gavage, at a single dose of 2000 mg test article/kg body weight according to OECD guideline 401 and EU method B.1. Based on the study results, there were no deaths as a result of treatment with the test article. Diarrhea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period. The body weight of the animals was within the normal range for rats of this strain and age. No organ abnormalities were observed at necropsy. So, the mean lethal dose (LD50) of FAT 20035/D after single oral administration to Wistar rats of both sexes, observed over a period of 14 days, is greater than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP compliance guideline study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Oral Toxicity:
In a GLP-compliant study performed according to OECD guideline 401 the test article FAT 20035/D was administered to a group of 5 male and 5 female Wistar rats by oral gavage, at a single dose of 2000 mg test article/kg body weight according to OECD guideline 401 and EU method B.1. Based on the study results, there were no deaths as a result of treatment with the test article. Diarrhea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period. The body weight of the animals was within the normal range for rats of this strain and age. No organ abnormalities were observed at necropsy. So, the mean lethal dose (LD50) of FAT 20035/D after single oral administration to Wistar rats of both sexes, observed over a period of 14 days, is greater than 2000 mg/kg.
In another two supporting studies, the acute oral LD50 in rats was established to be >2000 and >11260 mg/kg, respectively.
Acute inhalation Toxicity:
Currently, no study to assess acute inhalation toxicity of Acid Yellow 116 is available. However, low vapour pressure owing to high melting point (>350 °C), the substance is considered to have low volatility. Synthesis of this chemical is performed in a closed process; the final product consists of non-dusty granules. 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 vapour pressure and/or 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 dust-free powder or as a granulate, the exposure via inhalation is unlikely. The chemical showed low toxicity potential in the available acute oral (LD50>2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Considering the above arguments, low toxicity potential is expected on acute exposure of Acid Yellow 116 via inhalation route.
Acute Dermal Toxicity:
Currently, no study to assess the acute dermal toxicity of Acid Yellow 116 is available. However, this substance found to have high molecular weight 927.61 g/mol, this indicates that partition of the substance from stratum corneum into the epidermis will be low, thereby further limiting the absorption if any dermal exposure occurs. Synthesis of this chemical is performed in a closed process without isolation of reaction products. Isolated products consist of either liquid formulations or dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. The chemical showed low toxicity potential in the available acute oral (LD50>2000 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Similarly, absence of local toxicity in eye and skin irritation studies as well as absence of systemic toxicity in sensitization studies, further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Considering the above arguments, low toxicity potential is expected on acute exposure of Acid Yellow 116 via dermal route and hence acute toxicity testing by the dermal route was considered scientifically not necessary.
Justification for classification or non-classification
Based on the observed LD50of >2000 mg/kg bw in the acute oral 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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