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EC number: 257-486-4 | CAS number: 51868-46-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 04, 1990 to September 17, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
- Principles of method if other than guideline:
- Time pregnant CD (Sprague-Dawley) rats, 25 sperm-positive females per group, were exposed to the test substance by gavage once daily on Gestation Day (GD) 6 to 15 at 0, 500, 1000 or 2000 mg/kg bw/day in corn oil. Clinical observations were recorded, as well as maternal bodyweight and food consumption. At sacrifice on GD 20, the dams were evaluated for bodyweight, liver and gravid uterine weight. Ovarian corpora lutea were counted and the status of uterine implantation sites (i.e. resorptions, dead fetuses, live fetuses) was recorded. All fetuses were dissected from the uterus, counted, weighed, sexed and examined for external abnormalities. Approximately one half of the live fetuses in each litter were examined for visceral malformations and variations. The heads were fixed and examined for soft tissue craniofacial malformations and variations. Intact fetuses were examined for skeletal malformations and variations.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate
- EC Number:
- 222-813-1
- EC Name:
- 2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate
- Cas Number:
- 3618-72-2
- Molecular formula:
- C23H25BrN6O10
- IUPAC Name:
- 2-{[2-(acetyloxy)ethyl]({4-[ (E)-2-(2-bromo-4,6-dinitrophenyl)diazen-1-yl]-5acetamido-2-methoxyphenyl})amino}ethyl acetate
- Test material form:
- solid
- Remarks:
- Press cake
- Details on test material:
- Storage: room temperature
Different stock solutions in acetone and acetonitrile were prepared and stored in the refrigerator. Subsequent dilutions were used in the preparation of quality control fortification samples.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD
- Details on test animals or test system and environmental conditions:
- From: Charles River Laboraties
Number of females: 100 sperm-positive female rats (4 groups of 25 animals)
Age: ca. 10 weeks
Weight: 223 - 268g
Food: no. 5002 Purina Certified Rodent Chow and Water: deionized/filtered tap water ad libitum
Temperature: ca. 23°C
Humidity: 40 - 70%
Light: 12:12h light:dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Pregnant females were exposed to the test substance, by gavage once daily from gestational days 6 through 15 at doses of 0, 500, 1000 or 2000 mg/kg bw/day in corn oil (based on a range-finding study). The dosing volume was 10 mL/kg bw and was adjusted based on each animal's most recent body weight.
- Analytical verification of doses or concentrations:
- yes
- Remarks:
- HPLC (Waters 840 HPLC and data system)
- Details on analytical verification of doses or concentrations:
- Prior to formulation of study dosing suspensions, aliquots of formulations of test substance in vehicle, bracketing the range of concentrations to be used in this used were assayed for homogeneity and stability. Suspension concentrations were also verified for all dose levels. Dosing formulations were homogeneous and stable for at least 28 days and the concentrations were within 90-110% of the nominal concentrations. The content of test substance in the vehicle was below the detection limit.
Triplicate 1.0 mL samples of the vehicle solution (corn oil) and of the dosing formulations, 50.0, 100.0 and 200.0 mg/mL were analysed. - Details on mating procedure:
- For breeding, individual females were placed in the home cage of singly-housed males. On the following morning and each morning thereafter, the females were examinated for the presence of vaginal sperm (considered as GD 0). Sperm-positive females were individually housed until scheduled sacrifice on GD 20.
- Duration of treatment / exposure:
- From GD 6 to 15
- Frequency of treatment:
- Once daily
- Duration of test:
- Until GD 20
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
The doses were 0, 500, 1000 and 2000 mg/kg/day based on a rangefinding study in pregnant rats. The highest dose level was chosen to induce overt maternal toxicity, but not to cause a weight loss greater than 20% when compared to concurrent controls, nor to cause greater than 10% maternal mortality. The low dose was selected to be a maternal/developmental No Observable Adverse Effect Level (NOAEL). The mid dose was one-half the high dose and twice the low dose.
Examinations
- Maternal examinations:
- - Clinical observations: daily and twice daily during the dosing period (1-2h after dosing period)
- Maternal body weight: on gestational days 0, 6, 9, 12, 15, 18 and 20
- Food consumption: gestational days 0-6, 6-9, 9-12, 12-15, 15-18 and 18-20 - Ovaries and uterine content:
- - At scheduled sacrifice on gestational day 20, the dams were evaluated for body weight, liver and gravid uterine weight
- Ovarian corpora lutea were counted and the status of uterine implantation sites (i.e., resorptions, dead fetuses, live fetuses, pre and post-implantations) was recorded. - Fetal examinations:
- - Fetuses were dissected from the uterus, counted, weighted, sexed and examined for external abnormalities as well as for visceral malformations and variations.
- Sections of the heads were examined for soft tissue craniofacial malformations and variations.
- All fetuses were eviscerated, fixed in alcohol, and stained with alizarin red S/alcian blue.
- Intact fetuses were examined for skeletal malformations and variations. - Statistics:
- Appropriate General Linear Models procedures were used for the analysis of variances ANOVA + Bartlett's test for homogeneity of variance
Dunnett's Multiple Comparison Test
One-tailed or two-tailed tests were used depending on the endpoints
Chi-Square Test for Independance and Test for linear Trend on proportions
Fisher's Exact Probability Test - Indices:
- Gestational parameters (ovarian corpora lutea, uterine implantation sites, resorptions, dead fetuses, live fetuses, pre and post-implantation losses)
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- - Green, dark and/or green feces at 500 mg/kg bw/day and above
- Piloerection at all concentrations (GD 12-20)
- Vaginal bleeding at 2000 mg/kg bw/day in one dam on GD 15 - Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weight loss in 5, 2 and 2 dams in the groups 500, 1000 and 2000 mg/kg bw/day (GD 7 - 10)
- 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:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Two litters at 500 mg/kg bw/day were fully resorbed; all remaining pregnant animals had one or more live fetuses on GD 20
- Early or late resorptions:
- effects observed, non-treatment-related
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- The numbers of litters evaluated were 11-14 per groups
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Pregnancy rate was unexpectedly low (44-56%) and approximately equivalent across all groups
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Just slightly reduced at 2000 mg/kg bw/day with no obvious dose-related trends
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- One fetus in each treatment group exhibited external malformations
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Some malformations were observed in 0-3 fetuses in each group with no treatment-related patterns of incidence or severity.
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- No effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the maternal and developmental NOAELs for the test substance administered by gavage from GD 6 to 15 were determined to be >2000 mg/kg bw/day (i.e. 1992 mg a.i./kg bw/day).
- Executive summary:
A study was conducted to determine the developmental toxicity of the test substance (99.61% purity). in rat. Female Sprague Dawley rats (25/dose) were administered by gavage the following concentrations (dissolved corn oil, at a volume of 10 mL/kg bw): 0, 500, 1000 and 2000 mg/kg bw/day from gestational day (GD) 6 to 15. The homogeneity, stability and concentrations of dosing suspensions were analysed and were within acceptable values. Clinical signs were recorded daily and twice daily during the dosing period. Maternal body weight were measured on GD 0, 6, 9, 12, 15, 18 and 20 and food consumption on GD 0-6, 6-9, 9-12, 12-15, 15-18 and 18-20. At scheduled sacrifice on GD 20, the dams were evaluated for body weight, liver and gravid uterine weight. Ovarian corpora lutea were counted and the status of uterine implantation sites (i.e., resorptions, dead fetuses, live fetuses, pre and post-implantations) was recorded. Fetuses were dissected from the uterus, counted, weighted, sexed and examined for external abnormalities as well as for visceral malformations and variations. Sections of the heads were examined for soft tissue craniofacial malformations and variations. All fetuses were eviscerated, fixed in alcohol, and stained with alizarin red S/alcian blue. Intact fetuses were examined for skeletal malformations and variations. Except for green, dark and/or green feces at 500 mg/kg bw/day and above, piloerection at all concentrations (GD 12-20) and vaginal bleeding at 2000 mg/kg bw/day in one dam on GD 15, no other effects were observed. Gestational parameters (e.g. ovarian corpora lutea, uterine implantation sites, resorptions, dead fetuses, live fetuses, pre and post-implantation losses) were not modified by the treatment. Two litters at 500 mg/kg bw/day were fully resorbed; all remaining pregnant animals had one or more live fetuses on GD 20. Fetal body weight was slightly reduced at 2000 mg/kg bw/day with no obvious dose-related trends. Malformations (external and skeletal) were recorded but with no treatment-related patterns of incidence or severity. Under the study conditions, the maternal and developmental NOAELs were determined to be >2000 mg/kg bw/day (i.e. 1992 mg a.i./kg bw/day) (Rochelle, 1990).
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