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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 600-558-0 | CAS number: 104358-16-9
- 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
Key, rat, OECD 423, GLP, limit test: LD50 > 2000 mg/kg bw/d
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 MAR 2007 - 18 OCT 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD TG 423.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HsdCpb: WU,
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 163 g (151 - 173 g)
- Fasting period before study: yes (17 hours before treatment)
- Housing: separately in type III Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 42 - 65
- Air changes (per hr): about 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: day 1 To: day 15 - Route of administration:
- oral: gavage
- Vehicle:
- other: Methocel® K4M Premium solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: low toxicity and long term historical data
- Lot/batch no. (if required): ZDP 12/07, 14/07 and 15/07
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual):
Directly before the administration the test material was prepared with the vehicle using a mini shaker (Vortex-Genie 2®) and an Ultra-Turrax ®device.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: -- - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The behavior and general condition of all rats were monitored for at least 6 hours after administration and checked then daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- The body weight data were entered into the validated PC-program "AKUDAT". The statistical evaluations of the body weight were carried out with the validated PC-program "TOX 511 A", developed by the Institute of Toxicology of Merck KGaA, Darmstadt. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on spread sheets
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the course of the study.
- Clinical signs:
- No signs of toxicity were detected in the 3 male and 3 female rats after treatment.
- Body weight:
- The body weight development of the rats was inconspicuous.
- Gross pathology:
- At necropsy, no organ alterations were seen.
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value for males and females is >2000 mg/kg bw after single oral treament in rats.
- Executive summary:
Study design
The test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg bw. The test material was suspended with aqueous Methocel® K4M Premium solution as vehicle. The GLP study was performed according to the OECD Guideline for Testing of Chemicals, No. 423.
Results
No signs of toxicity were seen in the rats (3 males and 3 females) after treatment with 2000 mglkg bw. There were no deaths during the course of the study.
The gross pathological examination revealed no organ alterations.
Conclusion
Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value for males and females is >2000 mg/kg bw after single oral treatment in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- A GLP-compliant key study according to OECD guideline is available. Therefore, the quality of the database is considered to be high.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the result of the available study, the registered substance is not subject to classification in accordance with Regulation (EC) No 1272/2008.
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.