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EC number: 258-110-1 | CAS number: 52697-38-8
- 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
Endpoint summary
Administrative data
Description of key information
No adverse effects were observed that could be related to the treatment with the test substance. Under the study conditions, the NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Remarks:
- 90-Day Oral Toxicity in Rodents
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Completed on February 15, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read across is based on the same physico-chemical properties, a close structural similarity and the same mechanism of action during use processes.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- Source: Disperse Blue 79:1
Substance Name: 2,2’-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate
EC Number: 222-813-1
CAS Number: 3618-72-2
- Target: Disperse Violet 93:1
Substance Name: N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
EC Number: 258-110-1
CAS Number: 52697-38-8
3. ANALOGUE APPROACH JUSTIFICATION
see attachment section 13
4. DATA MATRIX
see attachment section 13 - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.2650 (90-Day Oral Toxicity in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- From: Charles River
Number: 68 males and 68 females
Age: ca. 7 weeks
Temperature: 20-25°C; Humidity: 40-70%; Light cycle: 12h light/12h dark
Diet: certified rodent chow (no. 5002, Ralston Purina Company) ad libitum; Water: by automatic watering system with demand control valves mounted on each rack - Route of administration:
- oral: gavage
- Details on route of administration:
- Gavage five days/week for 13 weeks at a volume of 10 mL/kg bw/day.
- Vehicle:
- corn oil
- Details on oral exposure:
- All animals were dosed based on their individual, most recent body weight.
Animals received the test substance suspensions at concentrations of 250, 1250 or 2500 mg/kg bw/day.
Control animals were administered the vehicle (corn oil) alone. - Analytical verification of doses or concentrations:
- yes
- Remarks:
- Liquid chromatography
- Details on analytical verification of doses or concentrations:
- Dosing suspensions were prepared weekly at concentrations of 0, 25, 125 and 250 mg/mL of Mazola corn oil.
Homogeneity and stability of the test substance under storage conditions were established prior to the start of the study.
Suspension concentrations were verified for all dose levels for Weeks 1, 2, 3, 4, 8 and 13.
All those parameters were within acceptable values. - Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- five days per week
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 500 mg/kg bw/day (actual dose received)
- Remarks:
- maximum feasible dose that can be administered based on the physical properties of the suspension and the considerations of the amount of corn oil administered over the 90-day period
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection: according to a dose range finding study.
- Positive control:
- no
- Observations and examinations performed and frequency:
- - Mortality: twice daily
- Clinical signs: daily + detailed observations once each week
- Body weights and body weight gains: weekly
- Food consumption: weekly
- Ophthalmic examinations (indirect ophthalmoscope): prior to the start of dosing and prior to sacrifice
- Hematology following an overnight fasting (retro-orbital sinus): AST, ALT, total protein, gamma glutamyl transferase, calcium, glucose, albumin, globulin (calculated), creatinine, total bilirubin, urea nitrogen, phosphorus, sodium, potassium, chloride
- Clinical chemistry following an overnight fasting (retro-orbital sinus): erythrocyte count and indices, hemoglobin, hematocrit, platelet count, total and differential leukocyte count - Sacrifice and pathology:
- - Gross pathology along with complete necropsy (+ gross examinations of lungs, liver, kidneys) for all animals
- Organ weights (after 13 weeks): liver, kidneys, spleen, brain with stem, heart, adrenals, testes and ovaries
- Histopathology (lungs, liver, kidneys, spleen, trachea, esophagus, stomach, intestine, brain with stem, eyes, exorbital lacrymal glands, zymbal glands, pituitary, salivary glands, heart and aorta, adrenals, thymic region, thyroid, nasopharyngeal tissues, vagina, mammary glands, testes and ovaries): saved in 10% neutral buffered formalin - Statistics:
- Data for continuous, parametric variables were intercompared for the dose and control groups by use of Levene's test for homogeneity of variances, by analysis of variance, and by pooled variance t-tests. Pathology frequency data were compared using Fisher's exact tests. 0.05 was used as the critical level of significance for all tests.
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Blue coloration of the skin and/or tail of some animals
(Females of the control group were not as healthy as the treated ones) - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Dosing accident in the control groups (females)
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the female control group (they were nutritionally affected by the large amount of corn oil)
No dose-response relationship in treated groups - Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Increased in females of the treated groups but consistent with the decrase observed in the female control group
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross or microscopic lesions
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 2 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed on any of the monitored parameters
- Key result
- Critical effects observed:
- no
- Conclusions:
- Under the study conditions, the NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day
- Executive summary:
A study was conducted to determine the repeated dose toxicity of the test substance (99.61% purity) according to EPA OTS Guideline 798.2650. Male and female Sprague Dawley rats (10/sex/dose) were administered by gavage the following concentrations (dissolved in corn oil, at a volume of 10 mL/kg bw): 0, 250, 1250 and 2500 mg/kg bw/day for five days/week during 13 weeks. The homogeneity, stability and concentrations of dosing suspensions were analysed and were within acceptable values. Mortality was checked twice daily. Clinical signs were recorded daily and detailed observations were realised once each week. Body weights and body weight gains and food consumption were measured weekly. Ophthalmic examinations (indirect ophthalmoscope) were made prior to the start of dosing and prior to sacrifice. Haematology following an overnight fasting (retro-orbital sinus) comprised measurements for AST, ALT, total protein, gamma glutamyl transferase, calcium, glucose, albumin, globulin (calculated), creatinine, total bilirubin, urea nitrogen, phosphorus, sodium, potassium and chloride. Clinical chemistry following an overnight fasting (retro-orbital sinus) comprised analyses of erythrocyte count and indices, haemoglobin, haematocrit, platelet count, total and differential leukocyte count. Gross pathology along with complete necropsy (gross examinations of lungs, liver, kidneys) were done for all animals. Organ weights were recorded for the liver, kidneys, spleen, brain with stem, heart, adrenals, testes and ovaries. Histopathology (lungs, liver, kidneys, spleen, trachea, oesophagus, stomach, intestine, brain with stem, eyes, exorbital lachrymal glands, zymbal glands, pituitary, salivary glands, heart and aorta, adrenals, thymic region, thyroid, nasopharyngeal tissues, vagina, mammary glands, testes and ovaries) was carried out on tissues saved in 10% neutral buffered formalin. Except for a blue coloration of the skin and/or tail of some animals, no adverse effects were observed that could be related to the treatment with the test substance. Under the study conditions, the NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Good quality
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was conducted to determine the repeated dose toxicity of the structural analogue (99.61% purity) according to EPA OTS Guideline 798.2650. Male and female Sprague Dawley rats (10/sex/dose) were administered by gavage the following concentrations (dissolved in corn oil, at a volume of 10 mL/kg bw): 0, 250, 1250 and 2500 mg/kg bw/day for five days/week during 13 weeks. The homogeneity, stability and concentrations of dosing suspensions were analysed and were within acceptable values. Mortality was checked twice daily. Clinical signs were recorded daily and detailed observations were realised once each week. Body weights and body weight gains and food consumption were measured weekly. Ophthalmic examinations (indirect ophthalmoscope) were made prior to the start of dosing and prior to sacrifice. Haematology following an overnight fasting (retro-orbital sinus) comprised measurements for AST, ALT, total protein, gamma glutamyl transferase, calcium, glucose, albumin, globulin (calculated), creatinine, total bilirubin, urea nitrogen, phosphorus, sodium, potassium and chloride. Clinical chemistry following an overnight fasting (retro-orbital sinus) comprised analyses of erythrocyte count and indices, haemoglobin, haematocrit, platelet count, total and differential leukocyte count. Gross pathology along with complete necropsy (gross examinations of lungs, liver, kidneys) were done for all animals. Organ weights were recorded for the liver, kidneys, spleen, brain with stem, heart, adrenals, testes and ovaries. Histopathology (lungs, liver, kidneys, spleen, trachea, oesophagus, stomach, intestine, brain with stem, eyes, exorbital lachrymal glands, zymbal glands, pituitary, salivary glands, heart and aorta, adrenals, thymic region, thyroid, nasopharyngeal tissues, vagina, mammary glands, testes and ovaries) was carried out on tissues saved in 10% neutral buffered formalin. Except for a blue coloration of the skin and/or tail of some animals, no adverse effects were observed that could be related to the treatment with the test substance. Under the study conditions, the NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day..
Justification for classification or non-classification
Based on the results of a repeated dose oral toxicity study in rat, no classification for this endpoint is required according to CLP (EC 1272/2008) criteria.
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.
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