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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 400-640-4 | CAS number: 198153-89-8
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- -
- EC Number:
- 400-640-4
- EC Name:
- -
- Cas Number:
- 198153-89-8
- Molecular formula:
- C32ClH25N10Na2O9S3
- IUPAC Name:
- disodium 2-(4-{[4-({3-[2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]-4-sulfonatophenyl}amino)-6-chloro-1,3,5-triazin-2-yl]amino}phenyl)-6-methyl-1,3-benzothiazole-7-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Yellow 161
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Remarks:
- non-consanguineous OF-1 albino mice
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA-CREDO, L'Arbresle, France (Charles River)
- Age at study initiation:
- Weight at study initiation: ca 25 g
- Assigned to test groups randomly: yes
- Housing: in groups of 5 separated by sex
- Diet (ad libitum): Aliment Rats-Souris Charles River, produced by U.A.R., Villemoisson, France
- Water (ad libitum): tap water
- Acclimation period: 1 week
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- We first carried out a preliminary range finding test by treating three groups of three male mice with doses of 500, 1000 and 2000 mg/kg given by intra-gastric intubation. As no death occurred, the dose of 2000 mg/kg was chosen for the micronucleus test. This concentration was the maximum quantity of the test substance which can be suspended in water.
For the micronucleus test, each treatment group was comprised of five male and five female mice receiving one intragastric intubation using 0.5 ml per 25 g body weight (20 mL/kg bw). Animals were sacrificed at regular intervals after treatment. - Duration of treatment / exposure:
- 1. Control (distilled water): 0.5 ml - sacrificed at 44 hours
2. Positive control (Thio-TEPA): 20 mg/kg - sacrificed at 44 hours
3. FAT 40162/B: 2000 mg/kg - Sacrificed at 20 hours
4. FAT 40162/B: 2000 mg/kg - Sacrificed at 44 hours
5. FAT 40162/B: 2000 mg/kg - Sacrificed at 68 hours. - Frequency of treatment:
- single
- Post exposure period:
- 20, 44, 68 h
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Thio-TEPA (N, N', N"-triethylenethiophosphoramide), reference N° 509-227, made by Lederle Laboratories Ltd.
Examinations
- Tissues and cell types examined:
- bone marrow - erythrocytes
Two types of erythrocytes were observed in the bone marrow smears: normo-chromatic (mature red blood cells about to pass into the blood stream) and polychromatic (immature red blood cells).
The proportion of polychromatic erythrocytes containing one or more micronuclei was compared with the total number of polychromatic erythrocytes, and statistical comparisons were made between these ratios for the different groups. A minimum of 500 polychromatic erythrocytes were counted per smear (two smears per animal). - Details of tissue and slide preparation:
- The method of preparation of mouse bone marrow smears for use in the micro-nucleus test was described in detail by Schmid (1977).
After sacrifice of the animals the femurs were taken and broken open at one end. Bone marrow cells were suspended in foetal calf serum using a small syringe, and the cells were centrifuged at 120 x g for 5 minutes. The super-natant was removed with a Pasteur pipette, cells were spread on a microscope slide and the smears allowed to dry in air. The following day smears were stained with Giemsa (1:6 in water) and mounted with a coverslip after drying. - Statistics:
- The proportion of polychromatic erythrocytes containing one or more micronuclei was compared with the total number of polychromatic erythrocytes, and statistical comparisons were made between these ratios for the different groups using BMPD computer programme 7D.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- There was no increase in the number of micronucleated polychromatic erythrocytes in animals exposed to 2000 mg/kg bw compared to negative control animals. In animals treated with Thio-TEPA there is a statistically significant increased number of micronucleated cells.
The ratio of polychromatic to normochromatic erythrocytes is markedly decreased in mice treated with Thio-TEPA. There is no statistical difference between the animals treated with the test substance and the negative control for this ratio.
Applicant's summary and conclusion
- Conclusions:
- The test substance did not exhibit any sign of cytogenicity in the mouse micronucleus test.
- Executive summary:
Reactive Yellow 161 was assayed for mutagenicity using the micronucleus test (EEC protocol). The compound was administered orally to mice at a concentration of 2000 mg/kg body weight. No mutagenic effect was observed in bone marrow smears taken 20, 44 and 68 h after administration of the test substance. A positive control (Thio-TEPA) administered at a concentration of 20 mg/kg showed pronounced evidence of mutagenicity 44 h after administration.
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.