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Diss Factsheets
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EC number: 617-357-9 | CAS number: 825633-75-8
- 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
For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 423. See chapter 13 report for a more detailed justification.
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:
- June 30, 2004 - Sepember 14, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted on December 17th, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Commission Directive of 30th. July 1996 adapting to technical progress for the 22nd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances
(Official Journal of the European communities No. L 248, September 30, 1996) - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Purity 99.9 %
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Directly before administration the test material was prepared with the vehicle using a mini shaker (Vortex Genie 2) and an Ultra-Turrax device (Janke and Kunkel). - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 7 to 9 weeks
- Weight at study initiation :178 g (range from 162 to 193 g)
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 - 24°C
- Humidity (%): 49 - 66%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime
IN-LIFE DATES: From: day 1 To: day 15 - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 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: well tolerated and established standard vehicle
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 (m) / 3 (f)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Standard statistical methods have been applied for data processing.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- All rats survived the observation period.
- Clinical signs:
- other: No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg.
- Body weight:
- other body weight observations
- Remarks:
- Body weight development of the treated rats was inconspicuous.
- Gross pathology:
- The gross pathological examination revealed no organ alterations.
- Interpretation of results:
- 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 is higher than 2000 mg/kg after oral treatment in rats.
- Executive summary:
This study was performed according to GLP and is fully compliant OECD TG 423. Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50value is higher than 2000 mg/kg after oral treatment in rats.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 423. See chapter 13 report for a more detailed justification.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Read Across
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Study design
The
test material was tested for acute toxicity in rats after oral
administration of 2000 mg/kg body weight. Directly before administration
the test material was prepared with aqueous Methocel®K4M
Premium solution as the vehicle.
Results
No signs of toxicity were detected in the rats (3 males and 3
females) after treatment with 2000 mg/kg. 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 materialh as no acute toxic potential and that the LD50value is higher than 2000 mg/kg after oral treatment in rats.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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 selection of acute toxicity – oral endpoint
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 423.
Justification for selection of acute toxicity – dermal endpoint
On 15 July 2014 the Competent Authorities for REACH and CLP (Caracal) have agreed that substances that are not toxic in acute oral tests need no longer be tested for acute dermal toxicity. Caracal agreed on proposals to amend REACH Annex VIII (point 8.5.3) so that substances that have not shown oral acute toxicity up to a limit dose of 2000mg/kg bodyweight would not also require dermal data. The test material does not provide evidence for acute oral toxicity. The LD50 exceeds 2000 mg/kg bw. Therefore no further testing for dermal toxicity is justified.
Justification for selection of acute toxicity – inhalative endpoint
For acute inhalation no experimental data are available, however, these data are not required as no exposure via inhalation is assumed based on the PC profile of the substance. Therefore all most likely main routes are covered by experimental data for acute toxicity.
Other information
Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity it is not considered to be classified according Regulation (EC) No 1272/2008.
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