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EC number: 275-602-1 | CAS number: 71550-21-5
- 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
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Principles of method if other than guideline:
- The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Following a sighting test at dose levels of 319 mg/kg (equivalent to 300 mg active ingredient/kg) and 2126 mg/kg (equivalent to 2000 mg active ingredient/kg) , a further group of four fasted females was given a single oral dose of test item, as a solution in distilled water, at a dose level of 2126 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. - GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)
- EC Number:
- 275-602-1
- EC Name:
- m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)
- Cas Number:
- 71550-21-5
- Molecular formula:
- C27H24N6O9S2.2C4H11NO2
- IUPAC Name:
- m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)
- Details on test material:
- Test item: Bayscript Gelb GGN
Test item identity (including alternative names): Bayscript Gelb GGN Benzenesulfonic acid, 3,3’-(carbonylbis(imino(3-methoxy- 4,1-phenylene)-2,1-diazenediyl))bis-, compd. with 2,2’-iminobis(ethanol) (1:2)
CAS Number: 71550-21-5
Appearance: Russet colored crystaline solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animal Information
Female Wistar (RccHan™:WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the mean body weight of any previously treated animals.
Animal Care and Husbandry
The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with softwood flake bedding. With the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Purpose
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Justification
Rats are the preferred species of choice as they are historically used for safety evaluation studies and are specified in the appropriate test guidelines.
Test Item Preparation and Analysis
For the purpose of the study the test item was freshly prepared, as required, as a solution in distilled water.
The test item was formulated within 2 hours of being applied to the test system. The suitability of the proposed mixing procedures was determined and specimen formulations were analysed to assess the stability and homogeneity of the test substance in the liquid matrix. These investigations demonstrated that formulations in the concentration range 1 to 200 mg/mL were stable following ambient storage (15-25°C) for one day and following refrigerated storage (2-8°C) for 15 days.
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulations from this study. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.
Following a sighting test at dose levels of 319 mg/kg (equivalent to 300 mg active ingredient/kg) and 2126 mg/kg (equivalent to 2000 mg active ingredient/kg) , a further group of four fasted females was given a single oral dose of test item, as a solution in distilled water, at a dose level of 2126 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
A total of five animals were therefore treated at a dose level of 2126 mg/kg in the study.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.
Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays.
Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Doses:
- 1 animal: 319 mg/kg bw = equivalent to 300 mg active ingredient/kg
5 animals: 2126 mg/kg bw = equivalent to 2000 mg active ingredient/kg - No. of animals per sex per dose:
- 1 female animal: 319 mg/kg bw = equivalent to 300 mg active ingredient/kg
5 female animals: 2126 mg/kg bw = equivalent to 2000 mg active ingredient/kg - Control animals:
- no
- Details on study design:
- Following a sighting test at dose levels of 319 mg/kg (equivalent to 300 mg active ingredient/kg) and 2126 mg/kg (equivalent to 2000 mg active ingredient/kg) , a further group of four fasted females was given a single oral dose of test item, as a solution in distilled water, at a dose level of 2126 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
- Statistics:
- Evaluation of data included identification of the number of animals that died during the study (or that were killed for humane reasons), and determination of the nature, severity, onset and duration of the toxic effects. If possible, the signs of evident toxicity were described. Evident toxicity refers to the toxic effects of sufficient severity that administration of the next higher dose level could result in development of severe signs of toxicity and probable mortality. Effects on body weights and abnormalities noted at necropsy were also identified.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: There were no deaths.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Hunched posture was noted in one treated animal during the day of dosing. The animal appeared normal one day after dosing. No abnormalities were detected in other treated animals.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2126 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight). There were no deaths.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2126 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight). There were no deaths.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Following a sighting test at dose levels of 319 mg/kg (equivalent to 300 mg active ingredient/kg) and 2126 mg/kg (equivalent to 2000 mg active ingredient/kg) , a further group of four fasted females was given a single oral dose of test item, as a solution in distilled water, at a dose level of 2126 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths. Hunched posture was noted in one treated animal during the day of dosing. The animal appeared normal one day after dosing. No abnormalities were detected in other treated animals. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2126 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight).
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