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EC number: 274-040-4 | CAS number: 69563-51-5
- 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 oral toxicity (LD50) in male and female rats was found to be 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:
- 2007
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: 11 weeks
- Fasting period before study: Fasted for approximately 17 to 18 hours
- Housing: In groups of three in Makroion type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 23/07 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum.
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark, music during the daytime light period. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight - Statistics:
- None
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: Red stained feces and urine were observed in all treated animals at the 5-hour reading or on test day 2. This symptom persisted up to test day 2 or 3 in the six treated females. Otherwise, no clinical signs were observed in any animal at any observation.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose (LD50) of FAT 36034/G is greater than 2000 mg/kg bw.
- Executive summary:
Acute oral toxicity was conducted with FAT 36034/G following OECD 423 guideline in female Wistar rats observed over a period of 14 days. No mortality was found during the study period. However, red stained feces and urine were observed in all treated animals at the 5-hour reading or on test day 2. This symptom persisted up to test day 2 or 3 in the six treated females. Otherwise, no clinical signs were observed in any animal at any observation. So, the median lethal dose (LD50) of FAT 36034/G is 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:
- OECD guideline study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral:
A key study was conducted to determine the acute oral toxicity of FAT 36034/G in albino rats according to OECD guideline 423. No mortality was found during the study period. However, red stained feces and urine were observed in all treated animals at the 5-hour reading or on test day 2. This symptom persisted up to test day 2 or 3 in the six treated females. Otherwise, no clinical signs were observed in any animal at any observation. The median lethal dose (LD50) of FAT 36034/G after single oral administration to female rats, observed over a period of 14 days was found to be greater than 2000 mg/kg body weight.
Another study (1993) conducted according to OECD 401, 92/69/EEC, B.l . adopted February 24, 1987. Upon oral administration and a 14 day post-treatment observation period, LD50 in male and female rats for FAT 36034/D was determined to be greater than 2000 mg/kg body weight.
Based on the various study results the acute oral LD50 for FAT 36034 in rats was considered to be greater than 2000 mg/kg.
Inhalation:
Currently no study to assess the acute inhalation toxicity potential of Disperse Red 86:1 is available. However, the vapour pressure for the substance can be considered low (3.69E-11Pa at 25 °C). Hence the substance is considered to have low volatility. 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 and 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 considered to be unlikely. Further the chemical was found to have low acute toxicity when tested via oral route with no mortality when tested upto 2000 mg/kg bw. Hence, considering all the above arguments, it is considered that Disperse Red 86:1 has a low toxicity potential via inhalation route and thus the study on acute inhalation toxicity is considered scientifically not necessary.
Dermal:
Currently no study to assess acute dermal toxicity of Disperse Red 86:1 is available. However, the molecular weight of the chemical is 408.43 g/mol, indicating it being large for dermal absorption. Hence, the dermal uptake for the chemical is expected to be limited. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50>2000 mg/kg bw), with no mortality or systemic toxicity being seen upto 2000 mg/kg bw, hence it does not need to be classified STOT SE. Similarly, absence of systemic toxicity in skin irritation studies, further supports the conclusion that no adverse effects are expected for the chemical via the dermal route. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Hence, low toxicity is expected on acute dermal exposure of Disperse Red 86:1 and testing by the dermal route was considered scientifically not necessary.
Justification for classification or non-classification
Disperse Red 86:1 was considered to be not toxic for acute exposure based on the available information, hence it does not warrant classification for acute toxicity as per the criteria of 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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