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EC number: 473-160-6 | CAS number: -
- 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:
- November 07, 2007 to January 07, 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- 2001
- Deviations:
- yes
- Remarks:
- no determination of food consumption and fetal sex, reporting deficiencies
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 473-160-6
- EC Name:
- -
- Molecular formula:
- Hill formula: C24 H15 Cu F2 N7 Na3 O9 S2
- IUPAC Name:
- dicopper(2+) hexasodium 2-[(E)-{[(Z)-(2-{3-[(2,6-difluoropyrimidin-4-yl)amino]-2-oxido-5-sulfonatophenyl}hydrazin-2-id-1-ylidene)(phenyl)methyl]imino}amino]-4-sulfonatobenzoate 2-[(E)-{[(Z)-(2-{3-[(4,6-difluoropyrimidin-2-yl)amino]-2-oxido-5-sulfonatophenyl}hydrazin-2-id-1-ylidene)(phenyl)methyl]imino}amino]-4-sulfonatobenzoate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shanghai Slaccs Animal Experimental Co., Ltd., Shanghai, China
- Age at study initiation: Not reported
- Weight at study initiation: Females 23-26g, males 28-35 g
- Fasting period before study: Not reported
- Housing: Single after mating
- Diet: SuZhou Shuangshi Laboratory Animal Feed Science Co., Ltd.
- Water: Drinking water complying China national standard, ad libitum
- Acclimation period: Approx. 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: 20-25 °C
- Humidity: 40-70%
- Air changes: Not reported
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: November 28, 2007 To: December 10, 2007
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 1.825 mg/mL, 3.65 mg/mL, 7.3 mg/mL
- Amount of vehicle: 20 mL/kg bw - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- One male mouse was housed with two female mice in the same cage from afternoon of the first day to the morning of the following day. Female mice were then examined for successful mating by observation of vaginal plug or sperm in female vaginal smear. The day on which a vaginal plug or sperm was observed was considered as mating success and day 0 of gestation.
- Duration of treatment / exposure:
- Gestation day 6-14
- Frequency of treatment:
- Daily
- Duration of test:
- 18 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 36.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 73 mg/kg bw/day (nominal)
- Dose / conc.:
- 146 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 30 pregnant animals
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses were selected based on acute oral toxicity data.
Doses were adjusted according to weight gain.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
Observations for clinical signs and mortality were made at least once daily, including changes in skin, fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern.
BODY WEIGHT AND BODY WEIGHT GAIN: Yes
Animals were weighed on days 0, 6, 9, 12, 14, 17 and 18.
FOOD CONSUMPTION: No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 18
- Organs examined: Uterus
OTHER:
Necropsy was performed on all dead animals and animals with signs of abortion or premature delivery. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
- Other: number of dead (early and late stillbirth) litters, number of live litters, body/tail length of live litters - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [1/3 of live fetuses]
- Skeletal examinations: Yes: [2/3 of live fetuses ]
- Head examinations: Yes: [all per litter]
- Fetal body weight - Statistics:
- Analysis of variance (one-way ANOVA, Dunnett's)
Chi-square and binomial distribution - Indices:
- Teratogenic rate (%) = (total amount of live litters with teratogenic effects/total amount of litters) x 100
(One live litter with more than one teratogenic effect was counted as one)
Teratogenic index = LD50 of females/minimum teratogenic dose
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Description (incidence and severity):
- In the high dose group 6/30 animals showed a skinny appearance whereas this was not apparent in the mid and low dose groups and the vehicle control group.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no dead animals observed during the course of the study.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- There was no significant change in body weight in all dose groups. The body weight gain was significantly decreased in the high dose group when compared to the vehicle control.
- Food consumption and compound intake (if feeding study):
- not examined
Maternal developmental toxicity
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- No significant differences in implantations were observed when compared to the vehicle control.
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- No significant difference in the number of pregnant rats with resorptions was observed when compared to the vehicle control.
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- The number of resorptions was not significantly increased when compared to the vehicle control.
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- No significant difference in the number of pregnant rats with dead litters was observed when compared to the vehicle control.
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- The number of pregnant rats in the treatment groups was comparable to the vehicle control group.
- Other effects:
- no effects observed
- Description (incidence and severity):
- There was no significant effect in the number of corpora lutea and the number of dead litters between the treated groups and the vehicle control.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 73 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
- Localisation:
- other: no adverse effects observed up to maximum dose level
Results (fetuses)
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- No significant differences were observed between the treatment groups and the vehicle control group.
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- No significant differences were observed in the number of live fetuses and fetal body weight between the treatment groups and the vehicle control group.
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The incidence (%) of fetuses with external malformations/variations was 0 (vehicle control), 0.5 (36.5 mg/kg bw/d), 0.7 (73 mg/kg bw/d) and 0.7 (146 mg/kg bw/d). No significant differences were observed between the treatment groups and the vehicle control group.
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The incidence (%) of fetuses with skeletal malformations/variations was 2.5 (vehicle control), 4.1 (36.5 mg/kg bw/d), 3.9 (73 mg/kg bw/d) and 6.5 (146 mg/kg bw/d). No significant differences were observed between the treatment groups and the vehicle control group.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- No visceral malformations/variations were observed in the treatment groups and the vehicle control group.
- Other effects:
- no effects observed
- Description (incidence and severity):
- Placental weight, fetus body and tail length: No significant differences were observed between the treatment groups and the vehicle control group.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 146 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: no adverse effects observed up to maximum dose
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- other: external/skeletal: not specified
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for maternal toxicity was determined to be 73 mg/kg bw/d based on reduced body weight gain. The developmental NOEAL was determined to be > 146 mg/kg bw/d.
- Executive summary:
The teratogenicity test of Blue MGI 1037-Na on mice was performed according to the Guidelines for the Testing of Chemicals (2004)414 which is referred to OECD 414.
Three different dose-level test groups of low, middle and high dosage, a negative control group and a Vitamin A positive control group were set up in this test. The dosage of each test group was 36.5mg/kg, 73mg/kg and 146mg/kg respectively. 30 pregnant female mice were assigned to each group. The day on which a vaginal plug or sperm were observed was counted as day 0 of gestation.
From day 6 to day 14 of gestation. 0.2 mL/10g bw of test substance was administered daily by garage to mice in 3 different dose-level test groups as well as control groups. Clinical observations
were recorded every day. From day 6 of gestation, mice were weighed every other 3 days dining the dosing period. All of female mice were sacrificed one day prior to the day of delivery (the 18th day since the gestation). Immediately after caesarean the uteri were removed and gravid uteri were weighed. Implantation status were record: the number of implantations, of dead litters (early stillbirth, late stillbirth), of resorptions, of live litters, of corpora luteas. The development of fetuses was recorded one by one: body weight, body length, tail length. And the examination of teratogenicity of fetuses: appearance, skeletal and organ alternatives. SPSS13.0 statistical software was applied to analyze all data and results. The maximum no observed adverse effect level (NOAEL) of teratogenicity test was obtained through statistical analysis.This teratogenicity test in mice indicated that Blue MGI 1037-Na had maternal toxicity to a certain extent: however, no embryonic toxicity and teratogenicity were observed. The maximum teratogenic NOAEL was 146 mg/kg in this test.
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