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EC number: 246-058-2 | CAS number: 24170-60-3
- 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
Endpoint summary
Administrative data
Description of key information
Acute Oral Toxicity Study:
FAT 36156/D was assessed for acute toxicity potential via ora route according to OECD Guideline 420 and EU Method B.1. Following a sighting test at a dose level of 2000 mg/kg bw, an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths and no signs of systemic toxicity. However, green stained feces were noted in the initial treated animal. Animals showed expected gains in body weight, except for one animal which showed expected gain in body weight during the first week but body weight loss during the second week. No abnormalities were noted at necropsy.In conclusion, the acute oral median lethal dose (LD50) of FAT 36156/D in the female Wistar rat was estimated to be greater than 2000 mg/kg bw. In a supporting study, FAT 36156/A was assessed for acute toxicity potential via oral route in albino rats. The study was carried out according to the OECD Guideline 401. Five rats per sex were used at each dose of 2000 and 5000 mg/kg bw. No mortality was seen at 2000 mg/kg bw, however 3 males and 2 females at 5000 mg/kg bw were found dead on Day 1. Hence, the acute oral median lethal dose (LD50) in rats was greater than 2000 mg/kg bw.
Acute Inhalation Toxicity Study:
Currently no study to assess the acute inhalation toxicity potential of Disperse Blue 165:1 is available. However, the vapour pressure for the substance can be considered low (2.2 x 10-11Pa). Hence, the substance is considered to have low volatility. Synthesis and spray drying 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 liquid formulation, the exposure via inhalation is considered to be unlikely. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50>2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified STOT SE. Taking the above arguments into account, low toxicity potential is expected on acute exposure of Disperse Blue 165-1 via inhalation route and hence testing by the inhalation route was considered scientifically not necessary.
Acute Dermal Toxicity Study:
Currently no study to assess the acute dermal toxicity of Disperse Blue 165:1 is available. However, it possesses molecular weight of 425.4 g/mol, hence considered to have limited dermal absorption. Also, it was found to have very low solubility in water (0.20 mg/L), hence dermal uptake is likely to be low as the substance is considered as not sufficiently soluble in water to partition from theStratum corneuminto the epidermis, again indicating limited dermal absorption. Synthesis and spray drying 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 toxicity studies (LD50>2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified STOT SE. Similarly, absence of local or systemic toxicity in skin irritation and sensitisation studies further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Taking above arguments into account, low toxicity potential is expected on acute exposure of Disperse Blue 165 -1 via dermal route and hence acute toxicity testing by the dermal route was considered scientifically not necessary.
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:
- 25 August 2015 to 3 November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Test material identified as: FAT36156/D TE
SOURCE OF TEST MATERIAL
- Batch number of test material:
20140804
- Expiration date of the lot/batch:
21 August 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
room temperature in the dark - Species:
- rat
- Strain:
- Wistar
- Remarks:
- RCCHan:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Envigo RMS (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
8 to 12 weeks
- Weight at study initiation:
159 to 186 g
- Fasting period before study:
Overnight
- Housing:
in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
19 to 25
- Humidity (%):
30 to 70
- Air changes (per hr):
15
- Photoperiod (hrs dark / hrs light):
12 hours continuous light and 12 hours darkness - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths found during the study period.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period. However, green stained feces was noted in the initial treated animal on Days 1 to 6.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the FAT 36156/D in the female Wistar rat was estimated to be greater than 2000 mg/kg bw.
- Executive summary:
FAT 36156/D was assessed for acute toxicity potential via ora route according to OECD Guideline 420 and EU Method B.1. Following a sighting test at a dose level of 2000 mg/kg bw, an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths and no signs of systemic toxicity. However, green stained feces were noted in the initial treated animal. Animals showed expected gains in body weight, except for one animal which showed expected gain in body weight during the first week but body weight loss during the second week. No abnormalities were noted at necropsy. In conclusion, the acute oral median lethal dose (LD50) of FAT 36156/D in the female Wistar rat was estimated to be greater than 2000 mg/kg bw.
Reference
Individual Clinical Observations and Mortality Data
Dose Level mg/kg | Animal Number and Sex | Effects Noted After Dosing | Effects Noted During Period After Dosing | ||||||||||||||||
½ | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
2000 | 1-0 Female | 0 | 0 | 0 | 0 | 0F | 0F | 0F | 0F | 0F | 0F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2-0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2-1 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2-2 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2-3 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0 = No signs of systemic toxicity
F = Green stained feces
Individual Body Weights and Body Weight Changes
Dose Level mg/kg | Animal Number | Body Weight (g) at Day | Body Weight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | ||
2000 | 1-0 Female | 160 | 180 | 188 | 20 | 8 |
2-0 Female | 159 | 173 | 200 | 14 | 27 | |
2-1 Female | 171 | 188 | 199 | 17 | 11 | |
2-2 Female | 186 | 203 | 200 | 17 | -3 | |
2-3 Female | 164 | 176 | 180 | 12 | 4 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- High quality GLP 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
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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