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EC number: 948-047-4 | 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
Endpoint summary
Administrative data
Description of key information
In a reliable in vivo study male and female rats were administered an analogue substance via oral gavage for 90 days at the approximate dosages of 100, 300 and 1000 mg/kg/day. No mortality occurred and no treatment-related clinical signs were observed during the study. No signs of toxic effects, which could be considered adverse, were seen during the study. No changes of toxicological relevance were observed in body weight and food consumption. In females from the 100 mg/kg bw/day group only the relative organ weights of kidney and brain were slightly increased. No lesions were recorded at ophthalmological examination. No treatment-related findings were reported at post mortem macroscopic observations and histopathological examination. In conclusion, no treatment-related changes, which could be considered adverse, were observed in male and female rats following dosing with the substance, when administered via oral gavage for 90 consecutive days at the approximate dosages of 100, 300 and 1000 mg/kg/day. Therefore, it can be concluded that the No Observed Adverse Effect Level (NOAEL) for this study was 1000 mg/kg/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-across from a K1 study therefore K2 is the maximum Klimisch score assignable
- Justification for type of information:
- A read-across justification is provided in section 13 of the IUCLID file.
- Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Züchter Winkelmann, Borchen, Germany
- Age at study initiation: approx. 4 weeks
- Weight at study initiation: 46 - 58 g (males) and 46 - 57 g (females)
- Housing: 2-3 animals in Makrolon-cages Typ M 5 (EBECO, Castrop-Rauxel, Germany)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 38-70
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Daily, immediately before dosing
VEHICLE
- Justification for use and choice of vehicle (if other than water): solubility of test substance
- Concentration in vehicle: 20, 60 and 200 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg bw/day - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily, 5 days per week
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
5 (additional in high dose group and control group) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Rationale for selecting satellite groups: high dose and control groups
- Post-exposure recovery period in satellite groups: 34 days - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily during acclimation period, twice daily during application period and daily on weekends and holidays.
- Cage side observations checked: mortality, intoxication symptoms.
BODY WEIGHT: Yes, as mean body weight.
- Time schedule for examinations: at study initiation, once during acclimatisation period, daily during the application period.
FOOD CONSUMPTION AND WATER CONSUMPTION: Yes, as g/animal/week.
- Time schedule for examinations: weekly.
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: day before sacrifice.
- Dose groups that were examined: high dose and control satellite groups.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 6 weeks application and at study termination.
- How many animals: all.
- Parameters checked: erythrocyte count, hematocrit, mean cell volume, hemoglobin, leucocyte count, thrombocyte count, differential blood count.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 6 weeks application and at study termination.
- How many animals: all
- Parameters checked: gamma glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatise, sodium, potassium, glucose, urea, protein, calcium, creatinine, cholesterol, chloride, bilirubin.
OTHER: organ weights: absolute and relative organ weights of brain, testes, heart, liver, spleen, adrenal gland, kidney, thymus. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, whole body, especially eyes, skin, abdomen, chest and skull.
HISTOPATHOLOGY: Yes, aorta thoracica, eye, colon, proventriculus, small intestine, cerebrum, urinary bladder, skin, heart, testes, hypophysis, cerebellum, liver, lung, trachea, axillary lymphnodes, mesentery lymphnodes, spleen, epididymis, adrenal gland, peripheral nerve, kidney, ovary, pancreas, prostate, vesicula seminalis, thyroid gland, salivary gland, esophagus, skeletal muscles, thymus, uterus, tongue, rumen. - Statistics:
- Student's t-test, steel test
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- non-adverse effects
- 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 mortalities occured.
BODY WEIGHT AND WEIGHT GAIN
Normal weight gain in all groups.
FOOD CONSUMPTION AND WATER CONSUMPTION
No abnormalities.
OPHTHALMOSCOPIC EXAMINATION
No damage.
HAEMATOLOGY
No abnormalities.
CLINICAL CHEMISTRY
No abnormalities.
ORGAN WEIGHTS
In females from the 100 mg/kg bw/day group only the relative organ weights of kidney and brain were slightly increased.
GROSS PATHOLOGY
No treatment related findings.
HISTOPATHOLOGY: NON-NEOPLASTIC
No treatment related findings.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
No treatment related findings.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects on: clinical signs; mortality; body weight; food consumption; ophthalmoscopic examination; haematology; clinical chemistry; gross pathology; organ weights; histopathology
- Critical effects observed:
- not specified
- Conclusions:
- The oral administration of the substance for 90 days, five days per week led to no significant adverse effects in male and female rats. Therefore the NOAEL for the substance is set to 1000 mg/kg bw/day.
- Executive summary:
Male and female rats were administered the substance via oral gavage for 90 days at the approximate dosages of 100, 300 and 1000 mg/kg/day.No mortality occurred and no treatment-related clinical signs were observed during the study. No signs of toxic effects, which could be considered adverse, were seen during the study. No changes of toxicological relevance were observed in body weight and food consumption.In females from the 100 mg/kg bw/day group only the relative organ weights of kidney and brain were slightly increased.No lesions were recorded at ophthalmological examination.No treatment-related findings were reported at post mortem macroscopic observations and histopathological examination.In conclusion, no treatment-related changes, which could be considered adverse, were observed in male and female rats following dosing with the substance, when administered via oral gavage for 90 consecutive days at the approximate dosages of 100, 300 and 1000 mg/kg/day.Therefore, it can be concluded that the No Observed Adverse Effect Level (NOAEL) for this study was 1000 mg/kg/day.
Reference
The oral administration of the test substance for 90 days, five days per week led to no significant adverse effects in male and female rats. Therefore the NOAEL for the test substance is set to 1000 mg/kg bw/day.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Sufficient to address requirements.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the findings of a reliable 90 day sub-chronic toxicity study conducted on an analogue substance, classification of the substance is not justified.
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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