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EC number: 203-213-9 | CAS number: 104-55-2
- 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:
The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats, mice and guinea pigs for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Acute Inhalation Toxicity:
The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0289 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.
Acute Dermal toxicity:
Based on all the available data, it was concluded that the test chemical was not toxic when applied dermally to the test animals. Thus, from all the observations and results, the LD50 of the test chemical was observed to be >2000 mg/kg bw, and is not classified as per the CLP criteria of classification and labelling.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity of test chemical in rats
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Fasting period before study: 18 hours
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- not specified
- Doses:
- 2220 mg/kg bw
- No. of animals per sex per dose:
- 10 (5/sex)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs - Statistics:
- not specified
- Preliminary study:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 220 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 910 - < 2 600
- Remarks on result:
- other:
- Remarks:
- No data
- Mortality:
- Death observed within 2-3 hours.
- Clinical signs:
- Clinical signs observed were depression, diarrhea and scrawny appearance
- Body weight:
- not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute oral LD50 value was considered to be 2220 mg/kg bw rats were treated with test chemical via oral route.
- Executive summary:
Acute oral toxicity study of test chemical was conducted on 5 male and 5 female rats at the dose concentration of 2220 mg/kg bw. The test chemical was administered via oral intubation route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of depression, diarrhea and scrawny appearance followed by death within 2 -3 hrs. Therefore, LD50 value was considered to be 2220 mg/kg bw with 95% confidence level of 1910 -2600 mg/kg bw, when rats were treated with test chemical via oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 400 mg/kg bw
- Quality of whole database:
- Data is from a Klimisch 2 source and provides a robust study summary.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Data is from study report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- According to OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age : 8 to 10 weeks
Sex : Male and female
Body weight range : 200±20g
Identification : By cage tag and corresponding colour body marking
Acclimatization : The healthy wistar albino rats selected for study acclimatized to standard laboratory condition for period of one week under close Veterinary supervision.
Randomization : After acclimation and Veterinary examination all the animals randomly divided into two groups and each group having five male and five female rats.
Nutritional conditions : Animals were fasted overnight prior to test and food was offered three hours after dosing.
Husbandry: Fasting
Environmental conditions: Air conditioned rooms with 10-15 air changes per hour, temperature between 22-250C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Accommodation: Groups of three animals of same sex in polypropylene cages with stainless steel grill top, facilities for food and water bottle, and bedding of clean paddy husk.
Diet: Pelleted feed supplied
Water: Fresh and clean water filtered through ‘Aqua Guard on line water filter’, was kept in glass bottles Ad libitum - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- Ten healthy wistar albino rats of both sex (ranging b.wt 200±20 gm) selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test drug Cinnamaldehyde was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals at termination of the study.
- Duration of exposure:
- 14 days
- Doses:
- Total: 20
Limit test: 2000 mg/Kg bw: 5/sex/dose
Confirmatory test: 2000 mg/Kg bw: 5/sex/dose - No. of animals per sex per dose:
- 10 (5male & 5 female)
- Control animals:
- not required
- Details on study design:
- APPLICATION OF TEST COMPOUND:
The test substance was applied uniformly over an exposed area of skin. The test compound was held in contact with the skin with an impervious dressing secured in place with an adhesive tape. The animals were then housed individually in cages with a collar around the neck in order to avoid the ingestion of the test compound. After 24 hours, the dressing was removed and the site of application was cleaned with lukewarm water wiping the test compound. - Statistics:
- No Data Available
- Preliminary study:
- The test compound applied at the dose level of 2000 mg/kg b.wt in Wistar albino rats did not show any mortality throughout the observation period. Clinical signs observed at this dose levels were decrease in cage side activity, abdominal respiration, and lacrimation. Moderate to severe degree of erythema and edema was also observed at the site of application at high level. This condition was observed upto 6 days from the day of application of test compound. Necropsy finding did not reveal any significant gross pathological changes in any of the Wistar albino rat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- dissolved
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No incidence of mortality was observed in Wistar albino rats after application of test compound.The period of application of test compound was 24 hours
- Clinical signs:
- The Wistar albino rats treated with the test compound showed moderate to severe clinical signs of intoxication viz; decrease in cage side activity, lacrimation and abdominal respiration. The local signs of dermal toxicity viz; erythema and edema were observed. This condition was observed upto 6 days from the day of application of test compound.
- Body weight:
- The body weight of all the animals was recorded on day 0 (pre treatment) and then 7th and 14th (post treatment) showed slightly decrease on day 7th while normal increase on day 14th when compared to day 0.
- Gross pathology:
- Pathology
Necropsy
Necropsy was carried out on all the animals that died during the study or surviving animals were sacrificed at the end of the study to observe any gross pathological changes. - Interpretation of results:
- other: Not Classified
- Conclusions:
- Based on all the available data, it was concluded that the acute dermal LD50 of test chemical was observed to be more than 2000 mg/kg b.wt. in Wistar albino rats when applied by dermal route.
- Executive summary:
An acute dermal toxicity study of test chemical was performed as per OECD TG 402 in Wistar Rats. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. 24 hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment. On test day 0, an amount of test item calculated based on body weight and moistened with 0.2 ml distilled water was applied uniformly over an exposed area of skin with an impervious dressing secured in place with an adhesive tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1-14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. Sever to moderate clinical signs of intoxication were observed like decrease in cage side activity, lacrimation and abdominal respiration.Local signs of dermal toxicity like erythema and edema were observed. The body weight gain was observed in male and female animals on day 7 and 14 as compared to day 0, except decline in mean body weight gain was observed in males on day 7. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Hence, LD50 value was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute dermal toxicity.
Reference
The toxicity of the test compound following dermal administration was assessed. Five female and five male rats were used per step for each dose level. The rats were observed for incidence of mortality and signs of intoxication for 14 days after the administration of test article.
Group |
Dose (mg/kg) |
WISTAR ALBINO RATS |
|
Nos. per group |
Animal ID |
||
Group-I |
2000 mg/kg b. wt |
10 (5 male & 5 female) |
20170-1, 2, 3, 4, 5, 6,7,8,9,10 |
Group-II |
2000 mg/kg b. wt |
10 (5 male & 5 female) |
20170-11, 12, 13 14, 15,16,17, 18,19,20 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Data is from a Klimisch 2 source and provides a robust study summary.
Additional information
Acute oral toxicity:
In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats, mouse and guinea pigs for test chemical. The studies are summarized as below:
Study 1:
Acute oral toxicity study of test chemical was conducted on 5 male and 5 female rats at the dose concentration of 2220 mg/kg bw. The test chemical was administered via oral intubation route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of depression, diarrhea and scrawny appearance followed by death within 2 -3 hrs. Therefore, LD50 value was considered to be 2220 mg/kg bw with 95% confidence level of 1910 -2600 mg/kg bw, when rats were treated with test chemical via oral route.
Study 2:
Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 3400 mg/kg bw. The test chemical was administered via oral gavage route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. 50% mortality was observed. Therefore, LD50 value was considered to be 3400 mg/kg bw, when rats were treated with test chemical via oral route.
Study 3:
Acute oral toxicity study of test chemical was conducted on mice at the dose concentration of 3400 mg/kg bw. The test chemical was administered via oral gavage route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. 50% mortality was observed. Therefore, LD50 value was considered to be 3400 mg/kg bw, when mice were treated with test chemical via oral route.
Study 4:
Acute oral toxicity study of test chemical was conducted on mice at the dose concentration of 2225 mg/kg bw. The test chemical was administered via oral: unspecified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs observed were motor suppression, blepharoptosis, and convulsions. Ataxia, tachypnea, dilation of ear vessels, loss of righting reflex.50% mortality was observed. Therefore, LD50 value was considered to be 2225 mg/kg bw, when mice were treated with test chemical via oral route.
Thus, based on the above summarized studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Acute Inhalation Toxicity:
The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0289 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.
Acute Dermal Toxicity:
Study 1:
An acute dermal toxicity study of test chemical was performed as per OECD TG 402 in Wistar Rats. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. 24 hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment. On test day 0, an amount of test item calculated based on body weight and moistened with 0.2 ml distilled water was applied uniformly over an exposed area of skin with an impervious dressing secured in place with an adhesive tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1-14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. Sever to moderate clinical signs of intoxication were observed like decrease in cage side activity, lacrimation and abdominal respiration. Local signs of dermal toxicity like erythema and edema were observed. The body weight gain was observed in male and female animals on day 7 and 14 as compared to day 0, except decline in mean body weight gain was observed in males on day 7. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Hence, LD50 value was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute dermal toxicity.
Thus, based on all the available data, it was concluded that the test chemical was not toxic when applied dermally to the test animals. Thus, from all the observations and results, the LD50of the test chemical was observed to be >2000 mg/kg bw, and is not classified as per the CLP criteria of classification and labelling.
Justification for classification or non-classification
Based on all the available data of the test chemical, it was concluded that the test chemical is not toxic when administered via oral and dermal route. Also, exposure of the test chemical through inhalation route is not likely to be possible taking into account the low vapour pressure of the test chemical. Thus, based on the criteria of CLP (Classification, Labelling and Packaging), the test chemical is not likely to be classified.
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