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EC number: 206-674-4 | CAS number: 366-18-7
- 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:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- unsuitable test system
- Remarks:
- irrelevant route of exposure.
Data source
Reference
- Reference Type:
- publication
- Title:
- Limb anomalies produced by 2,2'-dipyridyl in rats
- Author:
- Oohira A, Nogami H
- Year:
- 1 978
- Bibliographic source:
- Teratology. 1978, 18(1):63-70,
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female rats were treated with the test item (at 60 or 75 mg/kg bw) by intraperitoneal injection on gestation day 11.5, 12.5, 13.5, or 14.5. On gestation day 21, dams were sacrificed, the fetuses were removed, weighed, and examined externally. Fetuses were macerated and the cartilaginous skeleton was examined after staining with methylene blue.
Additionally, limb buds of fetuses removed 10 and 20 h after administration of the test item on day 12.5 were examined microscopically. - GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-bipyridyl
- EC Number:
- 206-674-4
- EC Name:
- 2,2'-bipyridyl
- Cas Number:
- 366-18-7
- Molecular formula:
- C10H8N2
- IUPAC Name:
- 2,2'-bipyridine
- Details on test material:
- - Name of test material (as cited in study report): 2,2'-Dipyridyl (DIP)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: about 250 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24°C
- Humidity (%): 55%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- ethanol
- Remarks:
- 25%
- Details on exposure:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 60 and 75 mg/kg bw
- Concentration (if solution): at 60 mg/kg bw: 20 mg/mL, at 75 mg/kg bw: 25 mg/mL,
VEHICLE
- Concentration (if solution): 25% - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: overnight
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Dams were killed on gestation day 21 after single exposure to the test item on gestation day 11.5, 12.5, 13.5, or 14.5.
- Frequency of treatment:
- single exposure
- Duration of test:
- Dams were killed on gestation day 21.
- No. of animals per sex per dose:
- 5, 6, or 10 litters (dams) per concentration and treatment day (see also table 1).
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CLINICAL OBSERVATIONS: Yes
MORTALITY: Yes - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: No
- Fetal examinations:
- - External examinations
- Skeletal examinations
- Fetal weight
- Mortality / resorptions
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Neither maternal mortality nor clinical signs of toxicity occurred with the dosage used.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Fetal death or resorption rates following maternal treatment with 2,2’-bipyridine were dependent on dose and administration time. The respective data are summarized in table 1. Briefly, treatment with higher doses or earlier in pregnancy resulted in higher mortality rates.
Fetal weight was also affected by administration of 2,2’-bipyridine, mean fetal wet weight gradually decreasing with later treatment (table 1).
Common external malformations produced in 21-day fetuses are listed and quantified in table 2. Most defects were seen in the limb. Few malformations were found in the cranial and costal bones or in the spinal column.
Digital defects were produced in the forelimbs of surviving fetuses in 97% by treatment with 60 mg/kg on day 12.5, and in 100% by treatment with 75 mg/kg on the same day. Digital defects in the hindlimbs in 70% and 86% of fetuses resulted from treatment with 75 mg/kg on gestation day 12.5 and 13.5, respectively, where missing or fusion of digits 3 and/or 4 was the most common defect. Fusion and shortening of tibia and fibula was almost uniquely produced by treatment on gestation day 12.5.
Ten hours after injection of 2,2’-bipyridine, large vacuoles containing dense granules were found in the cytoplasm of some mesenchymal cells in the forelimb bud of treated embryos; some of the granules in the vacuole fused with each other and showed amorphous structure. These vacuoles were not found in control tissue.
Twenty hours after treatment, mesenchymal condensations to form digital rays were not found while they were observed in the forelimb buds of control animals. Destruction of mesenchymal cells was evident, especially in the axial area of the treated limb bud.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: The effects of single administration of 2,2’-bipyridine to pregnant rats on litter size and mortality.
Treatment on GD |
Dose |
No. litters |
Mortality [%] |
No. live fetuses |
Wet weight [g] |
11.5 |
60 |
5 |
59 |
23 |
4.92±0.23 |
12.5 |
0 |
5 |
6 |
59 |
5.39±0.14 |
60 |
10 |
18 |
87 |
4.57±0.17 |
|
75 |
6 |
58 |
30 |
4.10±0.21 |
|
13.5 |
75 |
6 |
46 |
42 |
4.08±0.36 |
14.5 |
75 |
5 |
43 |
36 |
3.84±0.62 |
GD: gestation day
Table 2: The effects of single administration of 2,2’-bipyridine to pregnant rats on embryonal malformations [%].
Treatment on GD |
Dose |
Cleft palate |
Digital malformations |
Fusion of tibia and fibula |
|
Forelimb |
Hindlimb |
||||
11.5 |
60 |
0 |
9 |
0 |
0 |
12.5 |
0 |
0 |
0 |
0 |
0 |
60 |
11 |
97 |
14 |
9 |
|
75 |
33 |
100 |
70 |
77 |
|
13.5 |
75 |
7 |
5 |
86 |
0 |
14.5 |
75 |
17 |
0 |
0 |
0 |
GD: gestation day
Applicant's summary and conclusion
- Conclusions:
- Intraperitoneal application of 2,2'-bipyridine to pregnant rats resulted in distinct malformations in the fetuses. Pattern of malformation was dependent on dose and application time (gestation day). Abnormalities were mainly observed in the limbs of fetuses. Microscopic evaluation revealed destruction (autophagocytosis) of mesenchymal stem cells.
- Executive summary:
Developmental toxicity of 2,2’-bipyridine was assessed by intraperitoneal application of the test item (at 60 or 75 mg/kg bw) into pregnant rats on gestation day 11.5, 12.5, 13.5, or 14.5. On gestation day 21, dams were sacrificed; the fetuses were removed, weighed, and examined externally. Fetuses were macerated and the cartilaginous skeleton was examined after staining with methylene blue.
Additionally, limb buds of fetuses removed 10 and 20 h after administration of the test item on day 12.5 were examined microscopically.
Intraperitoneal application of 2,2'-bipyridine to pregnant rats resulted in distinct malformations in the fetuses. Pattern of malformation was dependent on dose and application time (gestation day). Abnormalities were mainly observed in the limbs of fetuses. Microscopic evaluation revealed destruction (autophagocytosis) of mesenchymal stem cells.
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