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Diss Factsheets
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EC number: 478-950-4 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Oral LD50 (rats / females) > 2000 mg/kg bw; LD50 cut-off is 5000 mg/kg bw (OECD 423, K, Rel.1, class method)
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:
- 21 March to 05 April 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 423 with minor deviations: age at study initiation, housing and feeding conditions, details of fasting not reported. These deviations do not affect the quality of the study and are not considered to be relevant.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001.
- Deviations:
- yes
- Remarks:
- age at study initiation, housing and feeding conditions, details of fasting not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Directive N° 2004/73/EC.
- Deviations:
- yes
- Remarks:
- age at study initiation, housing and feeding conditions, details of fasting not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2005-10-03 / Signed on 2005-12-13.
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Test item was considered at 100% for the study.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France.
- Weight at study initiation: 208-228 g
- Fasting period before study: No data
- Housing: No data
- Diet: No data
- Water: No data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21-23 °C
- Humidity: 38-60 %
IN-LIFE DATES: 21 March to 05 April 2006 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- distilled water
- Details on oral exposure:
- ADMINISTRATION: Animals received an effective dose of 2000 mg/kg bw of the test item, administered by force-feeding under a volume of 1.95 mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.
MAXIMUM DOSE VOLUME APPLIED: 1.95 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females/dose
- Control animals:
- yes
- Remarks:
- distilled water
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations were performed 30 minutes, 1, 3 and 4 h after test substance administration, and once daily thereafter for 14 days.
- Frequency of weighing: Body weights were observed on Days 0, 2, 7 and 14. - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- Cut-off
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occurred during the study.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No clinical signs related to the administration of the test item were observed.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw, the LD50 cut-off being 5000 mg/kg bw in female rats therefore it is not classified according to the criteria of the Regulation EC No. 1272/2008 (CLP) and of the GHS.
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw administered by force-feeding under a volume of 1.95 ml/kg bw. A control group of 6 animals was administered with distilled water. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
No mortality occurred during the study. No clinical signs related to the administration of the test substance were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. In this study, the oral LD50 of test substance was considered to be higher than 2000 mg/kg bw in female rats and the LD50 cut-off is 5000 mg/kg bw.
Under the test conditions, the test substance is not classified for acute oral toxicity according to the criteria of the Regulation EC No. 1272/2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The key study is GLP compliant and of high quality (Klimisch score = 1)
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
A key study was identified (Phycher, 2006, rel. 1). In this acute oral toxic class method study performed according to the OECD guideline No. 423 and in compliance with GLP, six fasted female rats received a single oral gavage dose of the test substance at a dose level of 2000 mg/kg bw, administered by force-feeding under a volume of 1.95 ml/kg bw. A control group of 6 females was administered with distilled water. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
No mortality occurred during the study. No clinical signs related to the administration of the test substance were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Oral LD50 > 2000 mg/kg bw
LD50 cut-off = 5000 mg/kg bw
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Acute toxicity (Oral):
Based on the available information, the substance is:
- not classified according to the CLP as the oral LD50 is higher than 2000 mg/kg bw.
- not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).
Acute toxicity (Dermal):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Acute toxicity (Inhalation):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the CLP and to the GHS as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3 / Narcotic effects) according to the CLP and to the GHS are not met since narcotic effects were not observed in the acute oral toxicity study.
Specific target organ toxicity: single exposure (Dermal):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Specific target organ toxicity: single exposure (Inhalation):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Aspiration hazard:
The substance is not a hydrocarbon and no effects were observed on lungs in oral studies, therefore the criteria for aspiration toxicity according to the CLP and to the GHS 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.
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