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EC number: 238-620-0 | CAS number: 14576-08-0
- 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: LD50 > 5000 mg/kg bw
Acute inhalation toxicity: Extrapolated from acute oral toxicity LC50 > 13000 mg/m3
Acute dermal toxicity: Extrapolation from acute oral toxicity: 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:
- 3 October, 1983 - 24 October, 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Five rats per sex per dose were exposed to the test substance via oral gavage. They were exposed to 3200, 4000, 5000 mg/kg bw. After an observation period of 14 days animals were necropsied.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Massachusetts, USA
- Weight at study initiation: 180 – 280 (after fasting)
- Fasting period before study: 18 hours
- Housing: individually, in stainless steel wire mesh cages,
- Diet: Wayne Lab Blox, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- only for 3200 mg/kg bw dosing
- Doses:
- 3200, 4000, 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed immediately and at 1, 4 and 24 hours after dosing and twice daily for 14 days. Body weights were recorded on the 14th day.
- Necropsy of survivors performed: yes - Preliminary study:
- In a dose-range finding study, 4 fasted animals, 2 per sex, were administered the test article at 500, 1600 and 5000 mg/kg bw, orally by gavage. Signs observed were abnormal gait, abnormal stance, decreased body tone, piloerection, decreased activity, lacrimation, semiprostration, salivation, poor grooming and prostration. None of the animals died at the 500 or 1600 mg/kg bw dose levels. 3 of 4 animals died at the 5000 mg/kg bw dose level.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - 1 out of 5 males and 2 out of 5 females died exposed to 3200 mg/kg bw
- 1 out of 5 males and 2 out of 5 females died exposed to 4000 mg/kg bw
- 1 out of 5 males and 1 out of 5 females died exposed to 5000 mg/kg bw - Clinical signs:
- other: Signs observed included decreased activity, abnormal stance, prostration, hypersensitivity, exophthalmos, tremors, semiprostration and dyspnea. One rat was observed with paralysis of both front pays due to self-traumatization.
- Gross pathology:
- - Necropsy of the animals that died revealed discoloration of the intestines and bladder. Hemorrhages in the stomach, cecum and bladder were observed. Necrotic livers and congested, edematous lungs were also observed.
- Atrophy of the testes was observed upon necropsy of the sacrificed male animals. No test article related lesions were observed in the females that were sacrificed. - Interpretation of results:
- other: criteria not met.
- Remarks:
- according to EU CLP criteria (1272/2008 and its amendments)
- Conclusions:
- The acute oral toxicity test showed an LD50 of >5000 mg/kg bw
- Executive summary:
In an acute oral toxicity test five Sprague-Dawley rats per sex per dose were exposed to the test substance via oral gavage to 3200, 4000, and 5000 mg/kg bw. Signs observed included: decreases activity, salivation, lacrimation, poor grooming, piloerection, decreased body tone, abnormal gait, abnormal stance, prostration, hypersensitivity, exophthalmos, tremors, semiprostration and dyspnea. One rat was observed with paralysis of both front paws due to self-traumatization. Three of ten animals died at the 3200 and 4000 mg/kg bw dose levels and two out of ten died at 5000 mg/kg bw. Necropsy of the animals that died revealed discoloration of the intestines and bladder. Hemorrhages in the stomach, cecum and bladder were observed. Necrotic livers and congested, edematous lungs were also observed. Atrophy of the testes was observed upon necropsy of the sacrificed male animals. No test article related lesions were observed in the females that were sacrificed. The acute oral LD50 for substance in both males, females and combined was determined to be >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute oral toxicity result is of sufficient quality and adequate for this dossier.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute oral toxicity: In an acute oral toxicity test five Sprague-Dawley rats per sex per dose were exposed to the test substance via oral gavage to 3200, 4000, and 5000 mg/kg bw. Signs observed included: decreases activity, salivation, lacrimation, poor grooming, piloerection, decreased body tone, abnormal gait, abnormal stance, prostration, hypersensitivity, exophthalmos, tremors, semiprostration and dyspnea. One rat was observed with paralysis of both front paws due to self-traumatization. Three of ten animals died at the 3200 and 4000 mg/kg bw dose levels and two out of ten died at 5000 mg/kg bw. Necropsy of the animals that died revealed discoloration of the intestines and bladder. Hemorrhages in the stomach, cecum and bladder were observed. Necrotic livers and congested, edematous lungs were also observed. Atrophy of the testes was observed upon necropsy of the sacrificed male animals. No test article related lesions were observed in the females that were sacrificed. The acute oral LD50 for substance in both males, females and combined was determined to be >5000 mg/kg bw.
Acute dermal toxicity: The acute dermal toxicity is > 5000 mg/kg bw based on LD50 of the oral route, using route to route extrapolation.
An acute inhalation toxicity. For inhalation, an oral LD50 of >5000 mg/kg bw can be converted into an inhalation LC50 > 13000 mg/m3 (using the algorithm 5000 mg/kg bw x 50/100 (oral versus inhalation absorption) x 1000*). The maximum saturates vapour pressure for Orange Flower ether is 685 mg/m3 (9.9 Pa (Vap Pr. Orange Flower ether) x 168 (MW) / 8.3 (R, gas constant) x 293 (°K)). This means that Orange Flower ether cannot reach a concentration higher than 685 mg/m3. Therefore an LC50 for inhalation (calculated to be >13000 mg/m3) cannot be reached and no classification and labelling is needed for the acute inhalation route. *(CLP guidance 2015, page 255).
Justification for classification or non-classification
Based on the available information classification and labelling for acute oral, dermal and inhalation toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments.
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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