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EC number: 294-955-2 | CAS number: 91771-62-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cyperus scariosus, Cyperaceae.
- 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
Skin Irritation:
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances.
Therefore, Cyperus scariosus, ext. was estimated to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Not Classified”.
Eye Irritation:
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Category 2”.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Weight of evidence approach based on structurally similar chemicals
- Justification for type of information:
- Weight of evidence approach based on structurally similar chemicals
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on similar chemicals
- Principles of method if other than guideline:
- The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal irritation potential of Cyperus scariosus, ext.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material: Cyperus scariosus, ext.- Common name: Nagarmotha essential oil- Substance type: Organic- Physical state: Liquid
- Species:
- other: humans
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: petrolatum
- Controls:
- not specified
- Amount / concentration applied:
- 4%, 4%, 5%
- Duration of treatment / exposure:
- 48 hours
- Observation period:
- 48 hours
- Number of animals:
- 25, 25, 25
- Details on study design:
- The study is based on weight of evidence approach from the read across values
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation observed
- Interpretation of results:
- other: not irritating
- Conclusions:
- Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, Cyperus scariosus, ext. can be classified under the category “Not Classified”.
- Executive summary:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of Cyperus scariosus, ext.
A skin irritation study was performed in humans to assess the irritation potential of the structurally similar chemical. The test chemical 4% in petrolatum was applied on the skin of human volunteers in a 48 hours closed patch test and observed for signs of irritation.
The test chemical was not irritating to humans after 48 hours exposure
This is supported by the results of a similar study performed for the other structurally similar chemical. The test chemical 4% in petrolatum was applied on the skin of 25 human volunteers in a 48 hours closed patch test and observed for signs of irritation. The test chemical was not irritating to humans after 48 hours exposure.
The above studies are further supported by the results of a similar study performed for another structurally similar chemical. The test chemical 5% in petrolatum was applied on the skin of 25 male volunteers in a 48 hours closed patch test and observed for signs of irritation.
The test chemical was not irritating to humans after 48 hours exposure.
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Not Classified”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: WoE based on similar chemicals
- Justification for type of information:
- WoE based on similar chemicals
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence report
- Principles of method if other than guideline:
- The weight of evidence report has been prepared based on the read across substances identified basedon structural and functional similarity to assess the ocular irritation potential of the test chemical
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material: Cyperus scariosus, ext.- Common name: Nagarmotha essential oil- Substance type: Organic- Physical state: Liquid
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- single
- Observation period (in vivo):
- 21 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The study design is based on the experimental results for the similar chemicals
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: not specified
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- signs of irritation observed
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Category 2”.
- Executive summary:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of Cyperus scariosus, ext.
An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical. The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 3 rabbits and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.
Conjunctival redness or chemosis was observed in 3 of 3 rabbits. Based on these observations, the test chemical was considered to be irritating to rabbit eyes, was classified under the category “Category 2B”.
This is supported by the results of a Draize test performed to assess the irritation potential of the other structurally similar chemical. Undiluted test chemical was instilled in the eyes of rabbits and observed for signs of irritation(dose, duration of exposure, observation period not mentioned).
A distinct eye irritating action was obtained. Hence the test chemical was considered to be irritating to eyes.
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Category 2”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of Cyperus scariosus, ext.
A skin irritation study was performed in humans to assess the irritation potential of the structurally similar chemical. The test chemical 4% in petrolatum was applied on the skin of human volunteers in a 48 hours closed patch test and observed for signs of irritation.
The test chemical was not irritating to humans after 48 hours exposure
This is supported by the results of a similar study performed for the other structurally similar chemical. The test chemical 4% in petrolatum was applied on the skin of 25 human volunteers in a 48 hours closed patch test and observed for signs of irritation. The test chemical was not irritating to humans after 48 hours exposure.
The above studies are further supported by the results of a similar study performed for another structurally similar chemical. The test chemical 5% in petrolatum was applied on the skin of 25 male volunteers in a 48 hours closed patch test and observed for signs of irritation.
The test chemical was not irritating to humans after 48 hours exposure.
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Not Classified”.
Eye Irritation
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of Cyperus scariosus, ext.
An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical. The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 3 rabbits and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.
Conjunctival redness or chemosis was observed in 3 of 3 rabbits. Based on these observations, the test chemical was considered to be irritating to rabbit eyes, was classified under the category “Category 2B”.
This is supported by the results of a Draize test performed to assess the irritation potential of the other structurally similar chemical. Undiluted test chemical was instilled in the eyes of rabbits and observed for signs of irritation(dose, duration of exposure, observation period not mentioned).
A distinct eye irritating action was obtained. Hence the test chemical was considered to be irritating to eyes.
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Category 2”.
Justification for classification or non-classification
The results of the experimental studies from the structurally similar read across substances indicate a possibility that Cyperus scariosus, ext. can be not irritating to skin, but causes irritation to eyes.
Hence by applying the weight of evidence approach, Cyperus scariosus, ext. can be considered to be not irritating to skin but irritating to eyes. It can be classified under the category “Not Classified” for skin irritation and “Category 2” for eye irritation as per CLP regulation.
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