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EC number: 469-500-8 | CAS number: 857035-95-1
- 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:
- 11 September 2006 - 09 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): R0054002C, synonym IMEXINE OBH
- Physical state: beige to yellow powder
- Purity: 99.7%
- Impurities (identity and concentrations): not indicated
- Purity test date: 20 July 2006
- Lot/batch No.: R0054002C 013 L 001, synonym 0604070001
- Expiration date of the lot/batch: 01 August 2007
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature and under nitrogen gas
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder Janvier, Le Genest-Saint-Isle, France
- Age at first treatment: 11 weeks
- Weight at first treatment (mean): 304 g
- Housing: individually
- Diet: ad libitum, SsniffR/M-H pelleted maintenance diet
- Water: ad libitum, tap water (filtered with a 0.22 µm filter)
- Acclimation period: 4-5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Relative humidity: 50 ± 20%
- Light/dark cycle: 12h/12h
- Ventilation: 12 cycles/hour of filtered, non-recycled air.
IN-LIFE DATES: beginning: 17 September 2006 / end: 8 October 2006
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: purified water, obtained by reverse osmosis
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was administered as a solution in the vehicle. The test item was mixed with the required quantity of vehicle in order to achieve the concentrations of 20, 60 and 200 mg/mL and then homogenized using a magnetic stirrer.
VEHICLE
- Concentration in vehicle: 20, 60 and 200 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg/day - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- determined in samples taken from each dosage form (including the control) prepared for use on the first day of dosing of the first animal and on the last day of dosing of the study - HPLC/UV
- Details on mating procedure:
- - Impregnation procedure: purchased time pregnant
- Proof of pregnancy: vaginal plug - Duration of treatment / exposure:
- day 6 to day 20 post-coitum
- Frequency of treatment:
- once daily
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day (f)
Basis:
actual ingested
- No. of animals per sex per dose:
- 24 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: no effects on dams and development at up to 1000 mg/kg/day in a range-finding study
- Rationale for animal assignment: stratified procedure based on body weight recorded on day 2 post coitum, to ensure comparatively similar mean body weights among groups
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule: regularly at 3- to 4-day intervals
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined daily: Yes
WATER CONSUMPTION: No
POST-MORTEM MACROSCOPIC EXAMINATION: Yes
- Sacrifice on gestation day# 21
- Examined: principal thoracic and abdominal organs - 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 resorptions: Yes
- Number of late resorptions: Yes
- Other: number of uterine scars, gross evaluation of placenta - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter
- Other : number dead and live, body weight, sex - Indices:
- % Pre-implantation loss = 100 * (Number of corpora lutea - Number of implantation sites) / Number of corpora lutea
% Post-implantation loss = 100 * (Number of implantation sites - Number of live fetuses) / Number of implantation sites - Historical control data:
- Not provided; not required for interpretation of the data obtained
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Reddish colored bedding was noted in all test item-treated females (probably related to the test item). At 1000 mg/kg/day, two females showed signs of poor clinical condition (loud and abdominal breathing and/or excessive salivation).
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Not required (no effects)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Not required (no effects). Satisfactory agreement between measured and nominal contents in administered dosage forms.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day for maternal and developmental toxicity.
- Executive summary:
The test item was administered daily, from day 6 to day 20 post-coitum, by the oral route (gavage), to mated female Sprague-Dawley rats at dose-levels of 100, 300 or 1000 mg/kg/day.
There were no mortalities nor any effects on maternal body weight gain or food consumption. Clinical signs were limited to reddish colored bedding (all treated females) and signs of poor clinical condition in only two high-dose females.
There were no treatment-related effects on pregnancy parameters (numbers of corpora lutea, implantation and live fetuses) nor on fetal body weight or sex.
There were no effects of treatment on fetal sex, mean fetal body weight or fetal development; no test item treatment-related external, visceral or skeletal malformations or variations were observed.
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