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EC number: 423-070-8 | CAS number: 58890-25-8
- 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:
- key study
- Study period:
- October-November 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed in 1994 according to OECD and/or EC guidelines and according to GLP principles. Consequently, data requirements according to updated guidelines are not included.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- KY-RB
- IUPAC Name:
- KY-RB
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): KY-RB
- Physical state: powder (white)
- Analytical purity: 93%
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 135-154 grams (males), 105-124 grams (females)
- Fasting period before study: no
- Housing: group housing of 5 animals/sex/cage in stainless steel suspended cages with wire mesh floors
- Diet: free access to standard pelleted laboratory animal diet (Kliba 343, Switzerland)
- Water: free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1 November 1994 To: 28 November 1994
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Remarks:
- specific gravity 1.036
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Formulations were prepared daily immediately prior to dosing. Adjustment was made for specific gravity of the vehicle.
VEHICLE
- Justification for use and choice of vehicle (if other than water): substance is stable in vehicle for at least 4 hours
- Concentration in vehicle: 0, 10, 40 and 200 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- For analysis of formulations, samples of week 2 formulations were analysed to check stability, homogeneity (highest and lowest concentration) and accuracy of preparations (all concentrations).
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 200, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on absence of toxicity in a 5-day dose range finding study (3 rats/sex/dose group at dose levels of 50, 200 and 1000 mg/kg bw/day, NOTOX Project number 131366).
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly and on the day preceding termination, prior to overnight fasting
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY: No
WATER CONSUMPTION: subjective appraisal was maintained during the study, but no quantitative investigation introduced as no effect was suspected
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: week 4
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: immediately prior to post mortem examination
- Anaesthetic used for blood collection: Yes (ether)
- Animals fasted: Yes (o/n)
- How many animals: all
- Parameters checked according to Guideline
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: immediately prior to post mortem examination
- Animals fasted: Yes (o/n)
- How many animals: all
- Parameters checked according to Guideline.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (according to Guideline)
HISTOPATHOLOGY: Yes (according to Guideline) - Statistics:
- Univariate one-way analysis of variance was used to assess the significance of intergroup differences.
If the variables could be assumed to follow a normal distribution, the Dunnett-test (many to one t-test) based on a pooled variance estimate was applied for the comparison of the treated groups and the control groups for each sex.
The Steel-test (many-one rank test) was applied when the data could not be assumed to follow normal distribution.
The exact Fisher-test was applied to the ophthalmoscopic examination data.
All tests were two-sided and in all cases p < 0.05 was accepted as the lowest level of significance.
Group means were calculated for continuous data and medians were calculated for discrete data (scores).
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:
- not examined
- 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:
- not examined
- Behaviour (functional findings):
- not examined
- 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
- Details on results:
- CLINICAL SIGNS AND MORTALITY: no mortality was observed; no treatment related clinical signs were observed. Incidental observations of no toxicologal significance included salivation, rales, a kink in the tail , alopecia and scabs
BODY WEIGHT AND WEIGHT GAIN: no differences between controls and treated animals over the study period
FOOD CONSUMPTION: no differences in food consumption before or after allowance for body weight between treated and control animals
OPHTHALMOSCOPIC EXAMINATION: no treatment related adverse effects
HAEMATOLOGY: no treatment related adverse effects; observed decrease in PT and PTT in treated females is the result of a slightly higher control value, and considered of no toxicological relevance.
CLINICAL CHEMISTRY: no treatment related adverse effects; observed statistically significant values are considered to result from slightly higher control values or to have occurred by chance.
ORGAN WEIGHTS: no treatment related difference between treated and control animals
GROSS PATHOLOGY: no treatment related observations; the reddened thymus observed in one treated male is within the normal range of spontaneous findings for rats of this strain and age.
HISTOPATHOLOGY: NON-NEOPLASTIC: no treatment related microscopic findings; the small number of changes observed were within the range commonly seen for rats of this strain and age
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No substance related adverse effects observed up to and including 1000 mg/kg bw/day, the highest dose tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Analysis of dose preparations:
Test substance formulations in propylene glycol were stable for at least 4 hours and formed a homogeneous suspension at the concentrations tested. Analysis of the accuracy of dose preparations revealed values within the range of 90% to 102% of nominal, which is considered to represent an acceptable level of accuracy for formulations of this type.
Applicant's summary and conclusion
- Conclusions:
- In an oral 28-day repeated dose toxicity study with rats, the NOAEL for KY-RB is ≥ 1000 mg/kg bw/day, based on the absence of substance related toxicologically relevant effects up to and including the highest dose tested.
- Executive summary:
Sprague-Dawley rats were administered KY-RB daily by gavage at dose levels of 0, 50, 200 or 1000 mg/kg bw/day for 4 weeks according to OECD 407. Formulation analysis confirmed that formulations were prepaed accurately and homogenously, and were stable under the conditions used in the study.
No substance related toxicologically relevant effects were observed up to and including the highest dose tested. Based on the absence of adverse effects, the NOAEL for KY-RB in this study is ≥1000 mg/kg bw/day.
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