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EC number: 440-240-7 | CAS number: 1282554-35-1
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-08-20 to 2010-02-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods (China) with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Section 4 of the Guidelines for the Testing of Chemicals: Health Effects (ministry of environmental protection of People´s Republic of China)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-Propyl-4-methyl-6-(1-methylbenzimidazole-2-yl)benzimidazole
- IUPAC Name:
- 2-Propyl-4-methyl-6-(1-methylbenzimidazole-2-yl)benzimidazole
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Storage condition of test material: storage room of the institute, -preservation condition: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SD
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Sino-British Sipper/BK Lab.Animal LTD.,CO.- Age at study initiation: 3 months- Weight at study initiation: after mating on day 0 mean: 275 +-19 to 277+-18 g- Housing: animal barrier system- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20-25°C- Humidity (%): 40-70%- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% Carboxymethyl Cellulose Sodium (CMC-Na)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test article was mixed with 1% CMC-Na. Animals were gavaged based on 10 mL/kg bwVEHICLE- Concentration in vehicle: The concentrations of the test substance in the vehicle were 0.3; 1.2; 5.0 and 20.0 mg/mL respectively.1% CMC-Na solution was used as negative control.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused- If cohoused: for mating female and male rats in the same cage- M/F ratio per cage: 25 females, no data about males - Length of cohabitation: until day 0- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy
- Duration of treatment / exposure:
- from day 6 to day 15 after their pregnancy
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
- No. of animals per sex per dose:
- 20 pregnant females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Repeated dose 28-day oral toxicity study in rats
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes- Time schedule: dailyBODY WEIGHT: Yes - Time schedule for examinations: day 0, 5, 8, 11, 14, 17, 20POST-MORTEM EXAMINATIONS: Yes - Sacrifice at day 20 (of pregnancy)
- 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 early dead fetus: Yes - Number of late dead fetus: Yes - Other: absorption fetuses, live fetuses were recorded
- Fetal examinations:
- - External examinations: Yes: [for all live fetuses]- Soft tissue examinations: No- Skeletal examinations: Yes: [2/3 fetuses from each litter]- Other examinations: splanchnic malformations [1/3 fetuses from each litter]
- Statistics:
- SPSS10.0 was used to perform statistics. All ratios were analyzed by x^2 test. Study measurements were analyzed by ANOVA or nonparametric statistics. Fetus body length, tail length and body weight were compared by t test. The data of fetuses was analyzed in the unit of litter.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yesDetails on maternal toxic effects:- Most pregnant rats in 200 mg/kg bw group appeared listless, fluffy fur and body weight descended after dosing 3 days. Four pregnant rats died one after the other on day 14 after getting pregnant. In the 200 mg/kg bw group, the dose was obviously toxic and the ration of death the pregnant rats appeared obvious toxicity and the ratio of death for the pregnant rats was more than 10% (4/25, mortality was 16%)- No abnormality was detected in the 3, 12 and 50 mg/kg bw groups (body weight, uterus and fetus weight, number of corpus luteum, of balastocyst implantation)- The five rats of non-pregnancy in each group received no treatment, and after negropsy on day 20 no obvious abnormality were found.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yesDetails on embryotoxic / teratogenic effects:no significant differences versus the control group in:- live fetus, dead fetus, number of absorption fetus, sexual ratio in the test groups 3, 12, 50 mg/kg bw- external malformations in the test groups 3, 12, 50 mg/kg bw (cephalocele, exencephaly; microcephaly, micrencephaly, microphthalmia; cleft lip, cleft mandible; gastoschisis, abdomen; hernia, umbilical hernia; spina bifida; small limb, short limb; syndactyly, polydactyly, adactyly; anury, bobtail; anal atresia; sacrococcygeal cleft)- skeletal malformations in the test groups 3, 12, 50 mg/kg bw (fontanel close incompletion; sagittal suture broadening; lack of skull; cervical vertebrae malformations; hyoid bone; clavicle malformations; rib malformations; sternum ossification rudimentary or not ossified; thoracic vertebra malformations; lumbar vertebra malformations; bone of limb; bone of poe; spinal aplasia; pelvis malformations; coccyx; cauda vertebra; sphenoid malformations) - splanchnic malformations in the test groups 3, 12, 50 mg/kg bw (cleft tongue, cleft palate; eyeball; brain; medulla oblongata and spinal cord; trachea and oesophagus; nose; heat; liver; lung; hydronephrosis or cavity; Spleen; diaphragm; genitalia; bladder)- growth and development at 50 mg/kg bw (fetus body length; fetus tail length; fetus bodyweight)significant differences versus the control group in:- growth and development at 3 and 12 mg/kg bw (fetus body length; fetus tail length; fetus bodyweight)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- changes in litter size and weights
- changes in postnatal survival
- external malformations
- skeletal malformations
- other: splanchnic malformations, growth and development
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL of the substance item in this study is considered to be 50 mg/kg bw for maternal toxicity.
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