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EC number: 616-968-8 | CAS number: 8015-92-7
- 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
No in vitro skin or eye irritation studies are available or required.
The skin irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits in a in vivo study conducted according to French national protocols and compliant with GLP. 0.5 mL of a 20% (v/v) solution of the test material was applied to the clipped skin of 6 male New Zealand white rabbits, for 24 hours under occlusive coverage. Application sites were scored for erythema and oedema 30 minutes and 48 hours after removal of the occlusive capsule (i.e. 24 and 72 hours after application of the test item). The primary cutaneous irritation index was reported to be 0.29 (maximum 8), corresponding to a non-irritant substance (Clement, 1988).
The eye irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits in a in vivo study according to French national protocols and compliant with GLP. 0.1 mL of a 20% (v/v) solution of the test material was instilled into the conjunctival sac of the right eye of each of 6 male New Zealand white rabbits, without rinsing. The eyes were examined for effects on the conjunctiva, iris and cornea 1 hour, and 1, 2, 3, 4 and 7 days after instillation of the test item. The mean ocular irritation index was reported to be 0.33 (maximum 110) after 2 days, and 0 after 3 days, corresponding to a non-irritant substance (Clement, 1988).
No relevant respiratory tract irritation data were identified.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 - 18 September 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- and to GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Protocol published by "Arrété" of 1 February 1982, in the "Journal Officiel de la République Française" of 21 February 1982
- Principles of method if other than guideline:
- Each test article was applied to intact and scarified skin of rabbits, for 24 hours under occlusive coverage. Macroscopic examinations were carried out 30 minutes after removal of the patch and again 48 hours (i.e. 24 and 72 after application).
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Ref. 88257.
Lot 682. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Roucher/Bancel (France).
- Age at study initiation: "Adult"
- Weight at study initiation: 2.30 to 2.70 kg
- Housing: Individually housed in polystyrene cages with perforated flooring (internal dimensions 560 x 355 x 315 mm).
- Diet: Complete pelleted rabbit maintenance diet, about 150 g/animal/day.
- Water: Filtered and softened mains drinking water, ad libitum.
- Acclimation period: minimum 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum 19 °C
- Humidity (%): Not specified.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12 hours (07.30 - 19.30)
IN-LIFE DATES: Not specified. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- Abraded skin also evaluated in this study.
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 20% (v/v) - Duration of treatment / exposure:
- 24 hours.
- Observation period:
- 72 hours (final scoring of skin reactions was 72 hours after test item application)
- Number of animals:
- 6 males.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.29
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- Observations only made at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observations only made at 24 and 72 hours.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits. There was no indication of an irritating effect.
- Executive summary:
The skin irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits in a study according to French national protocols and compliant with GLP. 0.5 mL of a 20% (v/v) solution of the test material was applied to the clipped skin of 6 male New Zealand white rabbits, for 24 hours under occlusive coverage. Application sites were scored for erythema and oedema 30 minutes and 48 hours after removal of the occlusive capsule (i.e. 24 and 72 hours after application of the test item). The primary cutaneous irritation index was reported to be 0.29 (maximum 8), corresponding to a non-irritant substance.
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 - 18 September 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Protocol published by "Arrété" of 21 September 1984, in the "Journal Officiel de la République Française" of 24 October 1984 and 9 February 1985)
- Principles of method if other than guideline:
- Each test article was applied into the inferior conjunctival sac of rabbits without rinsing. The untreated eye served as a concurrent control. The cornea, iris and cornea were examined 1 hour after instillation of the test article, and then again after 1, 2, 3, 4 and possibly 7 days.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Ref. 88257.
Lot 682. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River (Cléon, France).
- Age at study initiation: "Adult"
- Weight at study initiation: 2.35 to 2.70 kg
- Housing: Individually housed in polystyrene cages with perforated flooring (internal dimensions 560 x 355 x 315 mm).
- Diet: Complete pelleted rabbit maintenance diet, about 150 g/animal/day.
- Water: Filtered and softened mains drinking water, ad libitum.
- Acclimation period: 28 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum 19 °C
- Humidity (%): Not specified.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12 hours (07.30 - 19.30)
IN-LIFE DATES: Not specified. - Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 20% (v/v) - Duration of treatment / exposure:
- Single instillation only.
- Observation period (in vivo):
- Up to seven days.
- Number of animals or in vitro replicates:
- 6 males.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
SCORING SYSTEM: See table.
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The eye irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits. There was no indication of an irritating effect.
- Executive summary:
The eye irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits in a study according to French national protocols and compliant with GLP. 0.1 mL of a 20% (v/v) solution of the test material was instilled into the conjunctival sac of the right eye of each of 6 male New Zealand white rabbits, without rinsing. The eyes were examined for effects on the conjunctiva, iris and cornea 1 hour, and 1, 2, 3, 4 and 7 days after instillation of the test item. The mean ocular irritation index was reported to be 0.33 (maximum 110) after 2 days, and 0 after 3 days, corresponding to a non-irritant substance.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In addition to the key skin irritation study (Clement, 1988) described above, two earlier skin irritation studies are briefly described in the peer-reviewed literature (Opdyke, 1974). In the first, Roman chamomile oil was applied undiluted to the intact and abraded skin of rabbits for 24 hours, under occlusion. The substance was found to be moderately irritating [with, presumably, a higher degree of irritation seen at abraded sites, although this is not specified in the citing source] (Moreno, 1973). In the other, Roman chamomile oil was applied undiluted to the skin of hairless mice. The substance was found to be non irritating (Urbach and Forbes, 1973). [No further details provided in citing source.]
The skin irritation potential to humans was evaluated in several studies described by the Cosmetic Ingredient Review (CIR) Expert Panel (Johnson et al., 2017). Skin irritation was not observed when Anthemis nobilis “flower oil” (4% in petrolatum) was assessed in a 48-hour closed patch test involving [an unspecified number of] individuals. In repeated insult patch tests in humans (HRIPTs), Anthemis nobilis essential oil [concentration unspecified] did not induce skin irritation in 104 and 110 patients. A skin care lotion containing 3% Anthemis nobilis “flower oil” was also tested in a HRIPT and found not to have a potential for eliciting dermal irritation.
No respiratory tract irritation data were identified. A new study was not conducted as it is not a REACH Standard Information Requirement.
Justification for classification or non-classification
Based on the results of the available laboratory animal in vivo skin and irritation studies (Clement, 1988), and supporting human evidence, Anthemis nobilis, ext., (Chamomile oil) does not require classification as a skin or eye irritant according to EU CLP criteria (EC 1272/2008).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.