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Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)
EC number: 943-062-2 | 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
FAT 20036 is found to have acute oral LD50 >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:
- From 14 April 1994 to 28 April 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/EEC, B.l. "Acute Toxicity-Oral", July 31, 1992
- Deviations:
- yes
- Remarks:
- The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.
- Qualifier:
- according to guideline
- Guideline:
- other: U. S. Environmental Protection Agency, Code of Federal Regulations 40, Part 798, Health Effects Testing Guidelines, Subpart B - General Toxicity Testing, Section 798.1175 "Acute Oral Toxicity"; Revised as of July 01, 1992
- Deviations:
- yes
- Remarks:
- The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Methods for New Chemical Substances according to the Revised Japanese Chemical Substance Law (March 31, 1987).
- Deviations:
- yes
- Remarks:
- The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Identification : IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F)
Description : Lumpy black powder
Batch number : 1
Identification : 097911-1
CAS·Nr : 075314-27-1
Purity: ca 97.7%
Expiry date: July 1999
Storage conditions: In the original container at room temperature away from direct sunlight. - Species:
- rat
- Strain:
- other: Rat, Hanlbm: WIST (SPF)
- 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.
- Weight at study initiation for males: 197.6 - 213.4 g.
- Weight at study initiation for females: 177.6 - 188.5 g.
- Age at study initiation: 8 for males and 10 for females
- Identification: By unique cage number and corresponding color-coded spots on the tail.
- Randomozation: Randomly selected at the time of delivery into groups of five.
- Acclimatization: One week under laboratory conditions, after health examination. Only animals without any visual signs of illness were used for the study.
Conditions:
Standard Laboratory Conditions.
Air-conditioned with 10-15 air changes per hour, a continuously monitored environment with a temperature of 22 ± 2 °C, a relative humidity between 36-58%, 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.
Accommodation:
Groups of five in Makrolon type-4 cages (size: 33 x 55 x 20 cm) with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
Diet:
Pelleted standard Kliba 343, Batch no.73/94 rat maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to application).
Water:
Community tap water from Füllinsdorf, available ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Bidistilled water
- Details on oral exposure:
- VEHICLE: Bidistilled water
TREATMENT:
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for 16 to 22 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
MAXIMUM DOSE VOLUME given: 10 ml/kg body-weight - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Mortality: Four times during test day 1 and daily during days 2-15.
- Frequency of observations and weighing: On test day 1 (pre-administration), 8 and 15.
- Clinical signs: Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily for surviving animals during days 2-15. All abnormalities were recorded
- Necropsy of survivors performed: Necropsies were performed by experienced prosectors. At the end of the observation period all animals were anesthetized by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH, D-88471 Laupheim) at a dose of at least 2.0 ml/kg body weight and sacrificed by exsanguination. The animals were examined macroscopically. - Statistics:
- The LOGIT- Model could not be used as no deaths occurred.
- Preliminary study:
- None
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No moratlity was observed.
- Clinical signs:
- No clinical signs of toxicity were observed during the observation period.
- Body weight:
- The rate of body weight gain of the animals during the observation period was not affected by treatment with the test article.
- Gross pathology:
- No organ abnormalities were observed at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of FAT-20036/F in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw.
- Executive summary:
The test article IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was tested for acute oral toxicity according to OECD Guideline 401. FAT 20036/F was administered to a group of 5 male and 5 female rats by oral gavage, at the single maximal dose of 2000 mg test article/kg bw.
There were no deaths observed as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. There was no effect on body weight gain during the observation period. No organ abnormalities were observed at necropsy.
Based on the above findings, the mean lethal dose (LD50) of IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was found to be 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:
- High quality 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:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral:
Several studies investigating acute toxicity of FAT 20036 via oral route are available.
In the study (1994) designated to be key, the test article IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was tested for acute oral toxicity according to OECD Guideline 401. FAT 20036/F was administered to a group of 5 male and 5 female rats by oral gavage, at the single maximal dose of 2000 mg test article/kg bw. There were no deaths observed as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. There was no effect on body weight gain during the observation period. No organ abnormalities were observed at necropsy. Based on the above findings, the mean lethal dose (LD50) of IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was found to be greater than 2000 mg/kg bw.
Four others supporting studies are available where FAT 20036 was investigated over a dose range of 1000 to 20000 mg/kg bw. In these studies, no mortality was reported even at 5000 mg/kg bw. Hence, FAT 20036 can be assumed to have low acute toxicity via oral route.
Inhalation:
Currently no study to assess the acute inhalation toxicity potential of FAT 20036 is available. However, the vapour pressure for the target chemical is considered to be low owing to the high melting point (>350 °C), hence its 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. Further the chemical was found to have low acute toxicity when tested via oral route with no mortality and clinical signs when tested at 5000 mg/kg bw. Hence, considering all the above arguments, it is considered that FAT 20036 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 FAT 20036 is available. The
partition coefficient (n-octanol/water) of the chemical was determined
to be -0.70, while the water solubility was 53.7 g/l. These
physicochemical properties indicate chemical istoo hydrophilic to cross
the lipid rich environment of the stratum corneum, supporting the
hypothesis that dermal uptake for the chemical will be low. The
chemical showed low toxicity potential in the available acute oral
toxicity study (LD50 >5000 mg/kg bw), with neither mortality nor
clinical sings being seen. Similarly, absence of systemic toxicity in
skin irritation as well as sensitization studies, further supports the
conclusion that no adverse effects are expected 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 administration. Hence, low toxicity is expected on acute
dermal exposure of FAT 20036 and testing by the dermal route was
considered scientifically not necessary.
Justification for classification or non-classification
FAT 20036 is found to have low acute toxicity via oral route with LD50 >5000 mg/kg bw. Hence, it does not meet the criteria for classification according to the Regulation (EC) No. 1272/2008.
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