Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 690-526-2 | CAS number: 38632-47-2
- 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 comprehensive sub-chronic oral gavage toxicity study in rats conducted according to OECD TG 408 and GLP the NOAEL was reported to be 278 mg/kg.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 278 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Wistar rats of both sexes were orally gavaged with dose levels of 0, 93, 278 and 927 mg/kg body weight/day in a comprehensive sub-chronic oral toxicity study according to OECD TG 408 and GLP. The groups comprised 10 animals per sex which were sacrificed after 91/92 days of treatment. Clinical signs, outside cage observation, food consumption and body weights were recorded
periodically during pretest and treatment periods. Functional observational battery, locomotor activity and grip strength were performed during week 13. At the end of the dosing period, blood samples were withdrawn for hematology and plasma
chemistry analyses. Urine samples were collected for urinalyses. All animals were killed, necropsied and examined post mortem. Histological examinations were performed on organs and tissues from all control and high dose animals, and all gross lesions from all animals.
Test item related effects were observed on body weight. At 927 mg/kg/day, the mean body weights were significantly (approx. 10%) reduced (p<0.05) in males from days 43 to 71 of treatment. Although the differences noted from days 78 to 91 of treatment no longer attained statistical significance, they remained below those of the control males and were considered to be a test item-related effect. Females at this dose level did not have differences that attained statistical significance but remained below that of the control values (approx. 5%). No test item-related changes of toxicological relevance were noted for any organ weight at any dose level because the observations were not dose dependent, in general slight changes are reported within the historical control values and not correlated to histopathologic findings. Of the rats that survived until scheduled necropsy, there were no macroscopical findings that were test item-related.
In clinical biochemistry test item-related changes were restricted to elevated bile acid levels in males and females at the highest dose level of 927 mg/kg/day. All other differences were within the ranges of the historical control values or were unrelated to dose.
Microscopic Findings were observed in the liver of male animals; centrilobular to diffuse hepatocellular hypertrophy was recorded at minimal to slight severity. Since there is no dose response in the incidence or severity of the observation this observation is not regarded as compound related. Hyaline droplets nephropathy was found in males at 927 mg/kg/day. The nephropathy consisted of clearly incidence mean severity of hyaline droplets along with tubular basophilia. However, the increased severity was statistically not significant. Therefore, the toxicological of the nephropathy is not clear from this study. Since the hyaline droplets in the male rat relate to accumulation of alpha2-micoglobulin, and little or none of this protein is present in man, a nephropathy in man that involves the same mechanism is unlikely to occur with the test item (Ref. 1, Greaves 2000), i.e. this finding is adverse during exposure for the male rat but has limited relevance for other species including man.yaline droplets nephropathy was found in males treated with 927 mg/kg/day. The nephropathy consisted of elevated incidence mean severity of hyaline droplets along with tubular basophilia. However, the increased severity was statistically not significant. Therefore, the toxicological of the nephropathy is not clear from this study. Since the hyaline droplets in the male rat relate to accumulation of alpha-2-microglobulin and little or none of this protein is present in man, a nephropathy in man that involves the same mechanism is unlikely to occur with the test item. Although this finding is adverse during exposure for the male rat it has little or no relevance for other species including man.
Overall, in a comprehensive sub-chronic oral gavage toxicity study in rats conducted according to OECD TG 408 and GLP the NOAEL was reported to be 278 mg/kg.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
A subchronic (90-day) repeated dose toxicity study has been conducted since it's required for the registration of this substance in China.
Justification for classification or non-classification
No classification is required according to the EU classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).
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.