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Diss Factsheets
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EC number: - | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Between 3 March and 14 August 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recently conducted GLP compliant study using the most recent test methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd
- Age at study initiation: six to eight weeks old
- Weight at study initiation: males weighed 216 to 251g, the females weighed 163 to 196g
- Fasting period before study: not reported
- Housing: housed in groups of five by sex in solid floor polypropylene cages with stainless steel mesh lids and softwood flake bedding (Datesand Ltd, Cheshire, UK).
- Diet (e.g. ad libitum): free access to a pelleted diet (Rodent 2014C Teklad Global Certified Diet Harlan Laboratories UK, Oxon, UK)
- Water (e.g. ad libitum): free access to mains drinking water, supplied from polycarbonate bottles attached to the cage.
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 55 ± 15% respectively
- Air changes (per hr): at least fifteen air changes per hour
- Photoperiod (hrs dark / hrs light): low intensity fluorescent lighting was controlled to give twelve hours continuous light and twelve hours darkness
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food:
VEHICLE
- Justification for use and choice of vehicle (if other than water): Arachis oil
- Concentration in vehicle: 30, 300, 600, 1000 mg/kg/day
- Amount of vehicle (if gavage): 4 mg/kg/day
- Lot/batch no. (if required):
- Purity: 97.5% - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The standard and sample solutions were analysed by HPLC using the following conditions:
HPLC: Agilent Technologies 1050 or 1200,
Incorporating autosampler and workstation
Column: Gemini 5p C18 (50 x 4.6 mm id) @ 40°C
Mobile phase: Methanols. 1% formic acid (70:30 v/v)
Flow rate: 1.5 ml/min
UV Detector
Wavelength: 263 nm
Injection volume: 10 μl
Retention time: ~2.1 mins - Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
300 mg/kg/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
600 mg/kg/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: 14 day range finding study
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: JMETI/MHLW/ MOE guideline
- Post-exposure recovery period in satellite groups: 14 days
- Section schedule rationale (if not random): JMETI/MHLW/ MOE guideline - Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: before, after and 1 hour after dosing
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: before, after and 1 hour after dosing
BODY WEIGHT: Yes
- Time schedule for examinations: Day 1 and then at weekly intervals
FOOD Consumption: Yes
- Time schedule: weekly
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Daily
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Day 28 for all non recovery anumals and Day 42 for Recover animals
- Anaesthetic used for blood collection: No
- Animals fasted: No
- How many animals: all animals
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
URINALYSIS: Yes
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: No data
- Dose groups that were examined: No data
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table)
HISTOPATHOLOGY: Yes (see table) - Other examinations:
- Histopathology Sample Processing
All tissues were despatched to the Test Site (Harlan Laboratories Ltd, Zelgliweg 1, CH- 4452 Itingen, SWITZERLAND) for processing (Principal Investigator K Weber). The tissues shown in bold from all non-recovery control and 1000 mg/kg/day dose group animals were prepared as paraffin blocks, sectioned at nominal thickness of 5 pm and stained with Haematoxylin and Eosin for subsequent microscopic examination. Any macroscopically observed lesions were also processed together with the liver and spleen from all 30, 300 and 600 mg/kg/day dose group animals. In addition, sections of testes and epididymides from all Control and 1000 mg/kg/day males were stained with Periodic Acid-Shiff (PAS) stain and examined.
Microscopic examination was conducted by the Study Pathologist. All findings were entered into the ROELEE 84 Pathology computerisation system for tabulation and report production. - Statistics:
- Data were processed to give group mean values and standard deviations where appropriate.
All data were summarised in tabular form. Where appropriate, quantitative data were analysed by the Provantis™ Tables and Statistics Module. For each variable, the most suitable transformation of the data was found, the use of possible covariates checked and the homogeneity of means assessed using ANOVA or ANCOVA and Bartlett's test. The transformed data were analysed to find the lowest treatment level that showed a significant effect, using the Williams Test for parametric data or the Shirley Test for non- parametric data. If no dose response was found, but the data showed non-homogeneity of means, the data were analysed by a stepwise Dunnett (parametric) or Steel (non- parametric) test to determine significant differences from the control group. Finally, if required, pair-wise tests were performed using the Student t-test (parametric) or the Mann-Whitney U test (non-parametric).
Probability values (P) are presented as follows:
P < 0.01 ** P < 0.05 *
p > 0.05 (not significant)
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment related changes observed at the highest xposure level of 1000 mg/kg bw/ day
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Summary forms including tabular data are attached.
Applicant's summary and conclusion
- Conclusions:
- The NOEL following dosing over a period of 28 days by oral gavage is 1000 mg/kg bw/day.
- Executive summary:
The test substance has been dosed to rats at three exposure levels upto a maximum dose of 1000 mg/kg bw/ day over a period of 28 days by oral gavage with a 14 -day recovery period at high and solvent control dose levels. Under the conditions of the test, no toxicologically significant effects, clinically adverse observations and no macroscopic or microscopic observations. The observed No Effect Level is at the maximum tested dose of 1000 mg/kg bw/day
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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