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EC number: 303-161-8 | CAS number: 94158-87-9
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April/May 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt
- EC Number:
- 303-161-8
- EC Name:
- 4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt
- Cas Number:
- 94158-87-9
- Molecular formula:
- C22H(27-x)N3NaxO14S3 x<=2 C22H27N3O14S3.xNa
- IUPAC Name:
- 4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Yellow 160
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- WISKf (SPF71)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Mean weight:
Male: 176 g and Female: 172 g
- Age:
Male: 7 weeks and Female: 8 weeks
- Room T°: 22 +/- 3°C, Relative humidity: 50 +/- 20%, 12/12 hours light/dark
- Food: Rat diet Altromin 1324, ad libitum; Water: ad libitum
- Food deprivation: 16 hours before and 3 - 4 hours after application
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation:
males : mean = 170.6 g (= 100 %)
min = 167 g (- 2.11 %)
max = 174 g (+ 1.99 %)
females : mean = 172.6 g (= 100 %)
min = 170 g (- 1.51 %)
max = 175 g (+ 1.39 %)
- Fasting period before study: 16 hours before and 2 hours after application
- Housing: in groups of 5 on soft wood bedding
- Diet (e.g. ad libitum): Altromin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 45 ± 5
- Air changes (per hr): ca. 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 To: 27. April 1983
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 ml/kg bw
- Justification for choice of vehicle: good water solubility
- Lot/batch no. (if required): NA
- Purity: without contaminants
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw
- Doses:
- 5000 mg/kg bw in 20 mL/kg bw solution (at a concentration of 25% (W/V)).
- 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 mortality checks and clinical observations: multiple times on day 1; twice daily thereafter
weighing: weekly
- Necropsy of survivors performed: yes - Statistics:
- NA
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortalities observed
- Clinical signs:
- Clinical signs 2 hours after dosing included piloerection and hypoactivity. There were no clinical signs after the first day.
- Body weight:
- There were no effects on bodyweight.
- Gross pathology:
- No effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditons, the oral LD50 of the test substance in Wistar rats was determined to be >5000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance according OECD Guideline 401 and EU Method B.1, in compliance with GLP. Wistar rats (5 males and 5 females per group) received by gavage 5000 mg/kg bw (at 20 mL/kg at a concentration of 25%). Exposure was followed by a 14 day observation period. Mortality, clinical signs and bodyweight were observed. A gross pathological examination was conducted at test end. No mortality occurred throughout the study. Clinical signs 2 hours after dosing included piloerection and hypoactivity. There were no clinical signs after the first day. There were no effects on bodyweight. At gross necropsy, no abnormalities were noted. Under the study conditions, the oral LD50 of the test substance in Wistar rats was determined to be > 5000 mg/kg bw (based on test material) which equals to > 3000 mg/kg bw based on active ingredient.
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