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EC number: 236-114-4 | CAS number: 13171-00-1
- 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
Acute oral toxicity: somewhat similar to OECD TG 401: LD50 > 5000 mg/kg bw.
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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Pre-OECD, pre-GLP study, somewhat similar to OECD 401, without detailed documentation, result acceptable for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Remarks:
- Pre-OECD study, performed somewhat similar to OECD TG 401, reported without detailed documentation.
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not specified
- Route of administration:
- oral: unspecified
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period: 14 days
- Frequency of observations: daily
No further experimental details provided in the report. - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Four of ten animals died, deaths were observed on day 2, 4, 6 and 7.
- Clinical signs:
- Enteritis and pneumonia
- Interpretation of results:
- other: not classified: criteria not met
- Remarks:
- according to EU CLP Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- The key acute oral toxicity test (Denine, 1973) presented in this study record showed an LD50 of >5000 mg/kg bw.
Based on this key study and additional available studies presented in the Endpoint Summary, all presenting LD50's > 2000 mg/kg bw, the substance does not need to be classified for acute oral toxicity according to EU CLP Regulation (EC) No. 1272/2008 and its amendments. However, note that classification is warranted for GHS based on the additional available study from Avon (1977) presenting a LD50 of 3690 mg/kg bw, resulting in acute oral toxicity hazard Category 5 classification. - Executive summary:
Acute oral toxicity was assessed in a pre-OECD, pre-GLP study in which 10 rats were administered the substance at a dose level of 5000 mg/kg bw. Four of ten animals died, deaths were observed on day 2, 4, 6 and 7. Clinical signs included enteritis and pneumonia. The acute oral LD50 for the substance in rats was determined to be greater than 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute oral toxicity:
Key study:
Acute oral toxicity was assessed in a pre-OECD, pre-GLP study in which 10 rats were administered the substance at a dose level of 5000 mg/kg bw. Four of ten animals died, deaths were observed on day 2, 4, 6 and 7. Clinical signs included enteritis and pneumonia. The acute oral LD50 for the substance in rats was determined to be greater than 5000 mg/kg bw.
Additional available data:
In an additional available rat study, presented in the RIFM database (Research Institute for Fragrance Materials) the acute toxicity of the substance was assessed when administered by oral intubation to 5 female rats per group (Avon, 1977). The calculated LD50 is 3690 mg/kg bw. The animals were administered the test material in absolute ethanol (or undiluted) and were observed for a total of 7 days. At 215 mg/kg bw no effects were observed and 0/5 animals died. At 464, 1000, 2150 and 4640 mg/kg bw, respectively 1, 0, 1 and 3 animals per group of 5 died. Clinical signs included depression, a depressed, lethargic condition and lethargy. Necropsy observations in the animals that died were reported to be characteristic of the various stages of autolysis.
In a mouse acute oral toxicity study (presented in the RIFM database), using groups of 10 animals, the LD50 was greater than 20000 mg/kg bw (Givaudan, 1963). At 20000, 7500, 5000, 4000 and 2000 mg/kg bw no effects and no deaths were observed during the 5-day observation period.
Acute dermal toxicity:
Additional available data:
Next to acute oral toxicity also acute dermal toxicity is assessed in the key study (Denine, 1973). A group of 6 rabbits were administered 5000 mg/kg bw test substance. None of the animals died and no clinical signs were reported. The acute dermal LD50 > 5000 mg/kg bw.
Furthermore, in the additional available study from Avon (1977) also acute dermal toxicity was assessed. The study was conducted in groups of 5 female rats using following dose levels: 464, 1000, 2150, 4640 and 10000 mg/kg bw. The acute dermal LD50 exceeded 10000 mg/kg bw: no animals died within the 7 day observation period.
The additional available acute dermal toxicity data, presenting LD50’s > 5000 mg/kg bw, does not warrant classification for EU CLP.
Justification for classification or non-classification
Acute oral toxicity:
Based on the key study and additional available studies, all presenting LD50's > 2000 mg/kg bw, the substance does not need to be classified for acute oral toxicity according to EU CLP (EC No. 1272/2008 and its amendments).
However, classification is warranted for GHS based on the additional available study from Avon (1977) presenting a LD50 of 3690 mg/kg bw, resulting in acute oral toxicity hazard Category 5 classification for GHS.
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