Registration Dossier
Registration Dossier
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: 813-604-1 | CAS number: 68533-01-7
- 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 an acute oral toxicity study according to the Acute Toxic Class method, clinical signs were observed in the in female rats receiving 2000 mg/kg bw (impaired general state and piloerection in all animals), but not in the second group receiving 300 mg/kg. No mortality occurred in any of the dose groups. There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD Guideline 423 and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Strain: Crl:WI (Han) SPF
Age on day 0: Young adult females (approx. 10 – 11 weeks)
Supplier: Charles River Wiga GmbH, Germany
Arrival in testing facility: Acclimatization period of at least 5 days before the beginning of the experimental phase
Identification: cage cards and tail marking
Body weight on day 0: Animals of comparable weight (± 20% of the mean weight)
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C ± 3°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
Air changes per hour: approx. 10
Day/night rhythm: 12h/12h
Type of cage: Makrolon cage, type III
Number of animals per cage: single housing
Feeding: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
Drinking water: ad libitum
Bedding: H 15005-29; Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)
Enrichment: Wooden gnawing blocks (Type NGM E-022) ; ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% in deionized water
- Details on oral exposure:
- Test item preparation: The test item preparations were produced for each test group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally, the homogeneity of the test item preparations during application was ensured by stirring with a magnetic stirrer.
Administration volume: 10 mL/kg bw
Concentration in vehicle: 200 mg/mL (2000 mg/kg bw group), 30 mg/mL (300 mg/kg bw group)
Reason for selection of vehicle: A good homogeneity in water could not be guaranteed, because the test item preparation was a suspension. Therefore, a 0.5% solution of CMC in deionized water was applied.
Form of application: Suspension - Doses:
- 2000 and 300 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Fasting period: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
Time of day of administration: In the morning
Observation period: 14 days
Selection of doses: A starting dose of 300 mg/kg bw was chosen in the first step with 3 animals. As no mortality occurred, 2000 mg/kg were administered to another group of 3 animals in the second step. Because no mortality occurred, 2000 mg/kg bw were administered to another group of 3 animals in the third step.
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
Mortality: A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay.
Pathology: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.
Histology: No histological examinations were performed. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred in all test groups.
- Clinical signs:
- other: Clinical signs in the first 2000 mg/kg test group revealed in all animals impaired general state and piloerection at hour 2 after administration only. No clinical signs were observed during clinical examination neither in the second 2000 mg/kg test group
- Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (9 females).
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the median lethal dose of NM01 after oral administration was found to be greater than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class method, doses of 2000 and 300 mg/kg bw of the test item NM01 (preparations in 0.5% CMC-solution) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females, 300 mg/kg bw in 3 females). Clinical signs were observed in the first test group receiving 2000 mg/kg bw only (impaired general state and piloerection in all animals). No mortality occurred in any of the dose groups. There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period. The mean body weight of the surviving animals increased within the normal range throughout the study period with one exception in the 300 mg/kg bw test group. One animal showed stagnation of body weight in the second week, which was, however, considered an unspecific effect.
Reference
Additional information
Justification for classification or non-classification
As the oral LD50 in rats was found to be >2000 mg/kg, the classification criteria of the CLP regulation are not met.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.