Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 944-699-9 | 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
FAT 36002 is determined to have an acute oral LD50 of >5000 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:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See Chapter 13 for detailed read across justification. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Test substance: FAT 40284/A
Batch No.: EN 47342.52
Contents of active ingredients : 29.3 %
Physical properties: powder; dispersible in water; pH: 9.0 (lg/1 water)
Storage conditions: room temperature
Validity: November 1991
Safety precautions: gloves and face masks
Test material received: December 12, 1986 - Species:
- rat
- Strain:
- other: Tif: RAIf (SPF) hybrids of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Experimental Animals
Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initial Body Weight Range: 180 to 231 g
Initial Age: 7-8 weeks
Individual Identification: by colour code using picric acid
Husbandry:
The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
The animal room was air conditioned: temperature 22+_3° C, relative humidity 55+_15%, 12 hours light/day, approximately 15 air changes/h.
Diet:
Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum
Acclimatisation:
at least 5 days before administration - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5000 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: clinicals signs-daily, mortality check- daily twice, body weights weekly
- Necropsy of survivors performed: yes - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed throughout the observation period.
- Clinical signs:
- Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. Additionally, diarrhea was found three and five hours after the administration.
The animals recovered within 12 days. - Body weight:
- No adverse effects on body weight changes was observed.
- Gross pathology:
- No gross abnormalities were found.
- Conclusions:
- FAT 40284/A was determined to have a LD50 of >5000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the read across substance was evaluated in a study conducted according to OECD Guideline 401. A single group consisting 5 males and 5 females was administered a dose of 5000 mg/kg bw once and observed over a period of 14 days for clinical signs, mortality an body weight changes. The surviving animals were sacrificed and necropsies were conducted at the end of the observation period. Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. Additionally, diarrhea was found three and five hours after the administration. The animals recovered within 12 days. No mortality and no adverse effect on body weights were seen. No gross abnormalities were found during the necropsy. Hence, LD50 for FAT 40284/A was determined to be > 5000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Setacyl Blue P-RBLD, Pkg. //1 30-I 31-790 Standard
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Details on oral exposure:
- Investigational Procedures
Young albino rats of the Sprague-Dawley strain ranging in body weight from 150 to 227 grams were used as test animals. All animals were kept under observation for five days prior to experimental use, during which period they were checked for general physical health and suitability as test animals. The animals were housed in stock cages and permitted a standard laboratory diet plus water ad libitum, except during a 16-hour period immediately prior to oral intubation when food was withheld. Initial screening was conducted in order to determine the general level of toxicity of each of the fifteen samples. Selected groups of four r a t s each (two males and two females) were then intubated with the respective sample at several selected dose levels. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle. Following oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages and observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days. At the end of the observation period, the acute oral median lethal dose (LD50) of each test material was calculated using the techniques of Weil*, Thompson**, and Thompson and Weil***
*Weil, Carrol S. : Tables for Convenient Calculation of Median - Effective Dose (LD50 or ED50) and Instruction's in Their Use. Biometrics, Sept. 19 52.
**Thompson, William R. : Use. of Moving Averages and Interpolation to Estimate Median-Effective Dose. Bact. Rev. , Nov. 1947.
***Thompson, William R. and Weil, Carrol S.: On the Construction of Tables for Moving Average Interpolation. Biometrics, March 19 - Doses:
- 4.6, 6.8, 10.2, 15.4 g/kg bw
- No. of animals per sex per dose:
- 2 males, 2 females
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 11 300 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 650 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 4.6 g/kg bw dosing group: 0/4
6.8 g/kg bw dosing group: 0/4
10.2 g/kg bw dosing group: 1/4
15.4 g/kg bw dosing group: 4/4
Referenceopen allclose all
None
Dose (g/kg) Reaction Time of Onset Duration of Reaction Time of Death Following Dose Administration
4.6 Hypoactivity 1 hour 2 days -
Ruffed fur 6-22 hours 1 day -
6.8 Hypoactivity 1 hour 2 days
Ruffed fur 1 hour 2 days
Muscular weakness 6-22 hours 1 day
10.2 Hypoactivity 1 hour 3 days 6-22 hours
Ruffed fur 1 hour 3 days
Muscular weakness 5 hous 2 days
Diarrhea 6-22 hours 1 day
15.4 Hypoactivity 1 hour until death 6-22 hours
Ruffed fur 1 hour
Muscular weakness 5 hous
Diarrhea 5 hous
Prostration 5 hous
Acute Oral LD50: 11.3 g/kg.
Standard Deviation of LD50 +/- 1.2 g/kg.
* The test material was administered as a 50.0 percent (w/v) aqueous suspension. Doses are expressed in terms of Setacyl Blue P-RBLD.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- 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
Acute toxicity: oral
The acute oral toxicty of the test material was tested in an acute toxity study on the product in 1071. The test material was applied at 4 different doses to 2 male and 2 female rats each. Animals have been observed for a certain time (not reported in details, at least 3 days) following administration and clinical signs as well as deaths have been recorded and reported. The LD50 was calculated to >5000 mg based on the acitve ingredient and to 11.3 g/kg bw, based on the test material.
In addition, the acute oral toxicity of the read across substance was evaluated in a study conducted according to OECD Guideline 401. A single group consisting 5 males and 5 females was administered a dose of 5000 mg/kg bw once and observed over a period of 14 days for clinical signs, mortality an body weight changes. The surviving animals were sacrificed and necropsies were conducted at the end of the observation period. Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. Additionally, diarrhea was found three and five hours after the administration. The animals recovered within 12 days. No mortality and no adverse effect on body weights were seen. No gross abnormalities were found during the necropsy. Hence, LD50 for FAT 40284/A was determined to be > 5000 mg/kg bw.
Acute toxicity: inhalation
Currently no study to assess the acute inhalation toxicity of FAT 36002 is available. However, as the melting point >350 °C indicates low volatility, the substance may not be available for inhalation as a vapour. Further, the high values of the acute oral toxicity studies (LD50 >5000 mg/kg bw), indicate no adverse effects are expected via the inhalation route. Further, production and spray drying is performed in closed processes without isolation of reaction products. Isolated product is present in dust free granules (non-dusty solid). Therefore the study will be waived and the intrinsic property/toxicity potential will be extrapolated from the acute oral toxicity study. Experience with similar chemical structures demonstrated that it is very unlikely that toxicity related to intrinsic properties of the test item only show upviathe inhalation route and notviathe oral-gastric route of exposure. Further, production and spray drying is performed in closed processes without isolation of reaction products. Isolated product is present in dust free granules (non-dusty solid). Therefore the study will be waived and the intrinsic property/toxicity potential can be extrapolated from the acute oral toxicity study.
Acute toxicity: dermal
Currently
no study to assess acute dermal toxicity ofDisperse
Blue 056is
available.However,
it has very low solubility in water (<0.1 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. The
absence of toxicologically significant adverse effects in the acute oral
toxicity studies (LD50>5000 mg/kg bw), indicate Disperse Blue
056 to have very low acute toxicity. Similarly absence of systemic
toxicity or mortality in skin irritation as well as sensitization
studies, further supports the conclusion that no adverse effects are
expectedviathe dermal route. Further experience with similar
chemical substances has demonstrated that it is very unlikely that
toxicity related to the intrinsic properties of the test item only show
up upon dermal exposure and not after systemic application, hence
further experiments to assess dermal toxicity are not taken into account
and the intrinsic property/toxicity potential can be extrapolated from
the acute oral toxicity study.
Justification for classification or non-classification
Based on ther available data, FAT 36002 does not warrant calssification according to the CLP Regulation (EC n. 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.