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EC number: 284-635-0 | CAS number: 84961-46-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cinnamomum cassia, Lauraceae.
- 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>2000 mg/kg bw (similar to OECD 420)
Acute dermal toxicity: LD50=332 mg/kg bw (similar to OECD 402)
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:
- 25 Sept-16 Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is in accordance with GLP, according to OECD Guidelines No 420 "Acute Oral Toxicity - Fixed Dose Method" and (EC) 440/2008 No. B1 bis Acute Toxicity (Oral).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RccHan(TM):WIST (Harlan Laboratories, UK)
- Age at study initiation: 8-12 weeks, nulliparous and non-pregnant
- Weight at study initiation: 137-165 g
- Fasting period before study: overnight
- Housing:groups of four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, 2014C Teklad Global Rodent diet (Harlan Laboratories, UK)
- Acclimation period: al least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): al least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.91 ml/kg bw.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females (of which 1 animal was tested in the sighting study)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were made 0.5, 1, 2 and 4 hours after dosing, and subsequently once a day for up to 14 days. Morbidity checks were made twice a day. Bodyweights were recorded on day 0, 7, 14 or at death.
- All surviving animals were killed humanely and subjected to gross necroscopy. - Preliminary study:
- yes, one female at 2000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 1/5 animals died during test
- Mortality:
- One animal was found dead one day after dosing in the main study. In the sighting study with one animal no mortality was observed.
- Clinical signs:
- other: Signs of systemic toxicity noted four hours after dosing in the initial treated animal were ataxia, hunched posture and pilo-erection. There were no signs of systemic toxicity noted in the remaining animals.
- Gross pathology:
- Abnormalities noted at necropsy of the animal that died during the study were dark liver, dark kidney, gaseous stomach and pale gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw.
Therefore, the substance does not need to be classified as acute toxic via the oral route based on the criteria as outlined in 1272/2008/EC (CLP). - Executive summary:
An acute oral toxicity study - fixed dose method - was performed with five female Wistar strain rats. Study was performed according to guidelines OECD No. 420 and EC 440/2008 No. B1 bis. Following a sighting test at a dose level of 2000 mg/kg bw, an additional four fasted animals were given a single dose of test item at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. One animals was found dead one day after dosing in the main study. Signs of systemic toxicity noted in the initial treated animal were ataxia, hunched posture and pilo-erection. There were no signs of toxicity in the remaining animals tested in the main study. Surviving animals showed expected gains in bodyweight over the observation period. Abnormalities noted at necropsy of the animal that died during the study were dark liver, dark kidney, gaseous stomach and pale gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw under the conditions of this test. Therefore, the substance does not need to be classified as acute toxic via the oral route based on the criteria as outlined in 1272/2008/EC (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- 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:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 332 mg/kg bw
Additional information
Acute oral toxicity
The key study was a standard acute limit test, in which a single dose of Cassia oil (2000 mg/kg bw) was administered by oral gavage to 5 female Wistar rats. One animal was found dead one day after dosing, but no other mortality was observed up to 14 days after application. Based on these results, the oral LD50 was established to be >2000 mg/kg bw. A supporting study is available that confirms the LD50 is over 2000 mg/kg bw.
Acute dermal toxicity
Two studies were available for this endpoint, which were used in a Weight of Evidence approach:
The first available study was a standard acute test, in which 10 albino rabbits (2 per dose level) were exposed to a single dose of Cassia oil (168, 332, 600, 1323, 2625 mg/kg bw, calculated from mL/kg based on density). At the lowest dose none of the animals died, but at the dose level of 332 mg/kg bw, 1 of two animals (50%) died. At the higher dose levels all animals died. Based on the mortality rates the dermal LD50 was established to be 332 mg/kg bw.
The second study was performed according to an equivalent of guideline OECD 402 (acute dermal toxicity) but with a deviating dose (1000 mg/kg bw instead of 2000 mg/kg bw). 5 male and 5 female New Zealand White rabbits were selected. A single dose of the test article was applied for 24 hours. Eight of ten animals survived. Two males died on day 3 of the observation period. The LD50 was therefore determined to be greater than 1000 mg/kg body weight.
Based on the results of these two studies (WoE approach) it was decided to use the lowest reported LD50 of 332 mg/kg bw as the starting point for classification.
Justification for selection of acute toxicity – oral endpoint
The selected study is the key study for this endpoint.
Justification for selection of acute toxicity – dermal endpoint
No selection is made as a Weight of Evidence approach was followed which is described below.
Justification for classification or non-classification
Based on the available information, Cassia oil has shown to be non-toxic after oral exposure. Therefore, the substance does not need to be classified for Acute Oral Toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
Based on the available information, Cassia oil has shown to be toxic in contact with skin. Therefore, the substance needs to be classified for Acute Dermal Toxicity (Category 3 / H311) in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
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