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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 208-488-9 | CAS number: 530-62-1
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: hydrolysis product
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Imidazole
- EC Number:
- 206-019-2
- EC Name:
- Imidazole
- Cas Number:
- 288-32-4
- Molecular formula:
- C3H4N2
- IUPAC Name:
- 1H-imidazole
- Details on test material:
- 99,8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- 6d through 19 post coitum
- Frequency of treatment:
- 7d/weak
- Duration of test:
- 14d
- No. of animals per sex per dose:
- 25 time-mated female rats per dose
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
MATERNAL EFFECTS
Only pregnant dams or pregnant dams sacrificed at schedule were used for calculations. Animals which were totally or partially excluded were: 3 non-pregnant control animals; one non-pregnant animal from each dose group. No mortality was seen in any of the groups.
Low dose, 20 mg/kg bw/d:
No substance related effects seen.
Intermediate dose, 60 mg/kg bw/d:
No substance related effects seen, except slight but significant decrease of body weight gain on d 6-8 p.c.
High dose, 180 mg/kg bw/d:
Clinical data:
Transient salivation was noted in 6/25 animals during days 15-19 p.c. starting few minutes after dosing and lasting 15
to 20 min. Vaginal hemorrhage on d 20 was noted in one animal.
Salivation was regarded to be treatment related due to bad taste or local affection of the upper digestive tract, but was not assessed as an adverse or toxic effect.
Food intake, body weights:
Food intake was significantly reduced (-13% compared to controls) during a period at the beginning of treatment on d 6-8 p.c. Body weight gain was also statistically reduced compared to controls on d 6-8 p.c. (-45%) and d 17-20 p.c. (-34%). However, at the end of the treatment period body weight was comparable in all groups.
Findings were regarded as being substance-induced and reflecting direct adverse effects on dams (d 6-8) and on fetuses (d 17-20; resorptions, lowered fetal body weight).
Corrected body weight gain was comparable in all dose groups.
Terminal examination of dams:
Uterus weight was significantly reduced (-26% vs. controls). Significantly increased postimplantation loss (43% vs 8% in controls) was due to late resorptions. 3/24 females resorbed all implants during the last treatment days and had no live fetuses at termination. The number of live fetuses per litter was significantly reduced. Additionally the number of live male fetuses per litter was significantly reduced.
Examination of fetuses
Sex distribution was comparable to control animals in all treatment groups. In high dose animals, placental weight was increased (+22% vs. control), whereas mean fetal body weight was reduced (-14%, both sexes combined).
External malformations (anasarca and/or cleft palate) were significantly increased in high dose fetuses (13/132 fetuses; ca. 10%) in 7/21 litters (=33%), i.e. 9% versus 0% affected fetuses/litter in the control group.
Soft tissue variations (dilated renal pelvis and ureter) were statistically significantly increased compared with controls (27.1% vs. 6.4%).
Skeletal malformations (shortened scapula, bent radius/ulna, malpositioned and bipartite sternebra) were significantly increased; noted in 7/73 fetuses (=9.6%) in 5/21 litters (=24%), i.e. 7.8% vs. 1.1% affected fetuses/litter in the control group. Also, significant increase of several skeletal variations (mainly delays in the ossification process) was noted (98.4% affected fetuses/litter in high dose group vs. 91.1% in control group).
Applicant's summary and conclusion
- Conclusions:
- Maternal toxicity was noted exclusively at 180 mg/kg bw/d as
substantiated by significantly reduced food intake at initiation of treatment and impaired body weight gains on days 6-8 p.c.. No signs of maternal toxicity were seen at 60
mg/kg bw/d and below.
Fetal development was adversely affected at 180 mg/kg bw/d as
substantiated by the high rate of late resorptions (3/24 animals showing complete resorption) which resulted in an elevated postimplantation loss and reduced fetal body weights.
At 180 mg/kg bw/d selective teratogenicity was indicated by increased occurrence of external and skeletal malformations and variations of which anasarca, cleft palate, shortened scapula, and incomplete or delayed ossifications were the most prominent. No increases were noted at 20 or 60 mg/kg bw/d.
Based on these findings NOAEL for maternal toxicity and for
prenatal developmental toxicity is 60 mg/kg/d
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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