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EC number: 820-015-3 | CAS number: 129874-15-3
- 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
The NOAEL of Everdirect SH12 >1000 mg/kg B.W. (OECD TG407).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 30, 2016 to January 04, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: BioLASCO Taiwan Co., Ltd.
- Age at study initiation: about 4-week old
- Housing: Male and female rats were fed, respectively. Two rats per cage in an autoclaved polyethylene cage.
- Acclimation period: 1 week
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Dose / conc.:
- 62.5 mg/kg bw/day (nominal)
- Remarks:
- Low dose group
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Remarks:
- Medium dose group
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- High dose group
- No. of animals per sex per dose:
- For male: six
For female: six - Control animals:
- yes, concurrent vehicle
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- For male rats:
The mean corpuscular hemoglobin concentration (MCHC) of low dose group and lymphocyte in all treatment groups were lower than control group (ρ<0.05). The eosinophil of low and high dose groups and monocyte of medium dose group were higher than control group (ρ<0.05).
For female rats:
The hematocrit (Hct) and mean corpuscular volume (MCV) of medium and high dose groups were significantly lower than control group (ρ<0.05). The mean corpuscular hemoglobin concentration (MCHC) of medium and high dose groups were significantly higher than control group (ρ<0.05). - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- For male rats:
The triglyceride (TG) of high dose group was significantly higher than control group (ρ<0.05).
For female rats:
The alkaline phosphatase (ALP) and the total bile acid (TBA) of low dose group were significantly lower than control group (ρ<0.05). The Ca and globulin of low dose group were significantly higher than control group (ρ<0.05). The alanine aminotransferase (ALT), the triglyceride (TG) and the total bile acid (TBA) of medium dose group were significantly lower than control group (ρ<0.05). The creatinine and the triglyceride (TG) of high dose group were significantly lower than control group (ρ<0.05). - Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- For male rats:
The absolute weight of kidney in high dose groups was significantly higher than control group (ρ<0.05). The relative organ weight of kidney in high dose group was significantly higher than control group (ρ<0.05).
For female rats:
The absolute weight of adrenal gland in high dose groups was significantly lower than control group (ρ<0.05). The relative organ weight of adrenal gland in high dose group was significantly lower than control group (ρ<0.05). - Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Kidney
Only one male rat in the high dose group showed a focal, slight tubular cyst in the kidney. Two Female rats in the control and one male rat in the high dose groups showed focal, slight tubular infarct in the kidney. Only one female rat in the control group showed focal, slight tubular regeneration in the kidney.
Liver
Only one female rat in the control group presented focal, slight necrosis in the liver.
Lung
One male rat in the control and one female rat in the high dose groups presented focal to multifocal, minimal to slight inflammation in the lungs.
Thyroid gland
Only one female rat in the high dose group presented focal, slight, mononuclear cell infiltration in the thyroid gland. Only one female rat in the high dose group presented focal, slight, macrophage infiltration in the thyroid gland. - Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food efficiency
- haematology
- histopathology: non-neoplastic
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- Critical effects observed:
- no
- Conclusions:
- According to OECD 407 test method, the NOAEL of Everdirect SH12 for the rats was great than 1000 mg/kg B.W..
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-151100083001EN and OECD 407 (OECD, 2008).The test article was administered to the three treatment groups by oral gavage in a dose of 62.5, 250 and 1000 mg/kg B.W. for 28 consecutive days. There were six male and six female Sprague-Dawley rats in each group. Clinical observation of the rats was carried out daily and the body weight and feed intake of the rats were recorded once a week. Results of the study indicated that rats in all group gained weight normally and did not show any abnormal clinical signs and ophthalmological examination during the study period. At end of the study, there were no significant abnormalities of the urinalysis,haematologyand clinical biochemistry parameters between the treatment and control groups. Necropsy and histopathological examination indicated that no treatment-related change was found. On the basis of the test results given above, the NOAEL of Everdirect SH12 for the rats was great than 1000 mg/kg B.W..
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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
Repeated dose toxicity: via oral route-systemic effects
The test article was administered to the three treatment groups by oral gavage in a dose of 62.5, 250 and 1000 mg/kg B.W. for 28 consecutive days. There were six male and six female Sprague-Dawley rat in each group. Clinical observation of the rats was carried out daily and the body weight and feed intake of the rats were recorded once a week. Results of the study indicated that rats in all group gained weight normally and did not show any abnormal clinical signs and ophthalmological examination during the study period. At end of the study, there were no significant abnormalities of the urinalysis, haematology and clinical biochemistry parameters between the treatment and control groups. Necropsy and histopathological examination indicated that no treatment-related change was found.On the basis of the test results given above, the NOAEL of Everdirect SH12 for the rats was great than 1000 mg/kg B.W..
Justification for classification or non-classification
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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