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EC number: 946-253-9 | CAS number: -
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2015-10-19 to 2016-03-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study is performed according to OECD Guideline 405 (2012), and under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000), including the most recent revisions
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation
- EC Number:
- 946-253-9
- Molecular formula:
- Not applicable
- IUPAC Name:
- Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Spearmint Essential Oil, ex Mentha spicata
- Physical state: Clear colourless to pale yellow liquid
- Analytical purity: confidental
- Impurities (identity and concentrations): confidental
- Purity test date: confidental
- Lot/batch No.: confidental
- Expiration date of the lot/batch: confidental
- Storage condition of test material: at room temperature
Constituent 1
- Specific details on test material used for the study:
- spearmint oil
Spearmint, ext. (Mentha spicata L.)
EC 283-656-2
CAS 84696-51-5
Oil of spearmint - Native type
Oil of spearmint - Indian type
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France
- Age at study initiation: between 12 and 24 weeks old
- Weight at study initiation: at least 1.5 kg
- Housing: animals were individually housed in labeled cages with perforated floors and shelters.
- Diet (e.g. ad libitum): pellet diet for rabbits (approximately 100 grams per day) and wooden sticks
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24 °C
- Humidity (%): 40-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test item
- Concentration (if solution): n.a.
VEHICLE
The testitem was instilled undiluted, as delivered by the sponsor. - Duration of treatment / exposure:
- The animals were treated by instillation of the test item, and subsequently exposed (e.g. the eyes were not washed) to the test item for 72 hours (two test animals) or 7 days (sentinel).
- Observation period (in vivo):
- The sentinel animal was observed 1 hour after installation, and 24, 48 and 72 hours after (in total for 7 days). 2.5 weeks later the two other animals were observed in a similar way, but for 72 hours in total.
- Number of animals or in vitro replicates:
- Three in total.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data
SCORING SYSTEM:
The numerical scorings recorded were made in compliance with OECD guideline 405 (2012).
TOOL USED TO ASSESS SCORE:
If standard lighting was not considered to be enough, an ophthalmic examination lamp was used to examine the eyes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: three days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- All animals showed irritation of the conjunctivae; e.g. all animals showed discharge 1 hour after dosing the test substance. This was not observed after 24 hours for animal 1 and 2, and the discharge effect for the sentinel was reversible after 48 hours. In addition the sentinel suffered from redness for 72 hours. The redness observed for animals 1 and 2 was no longer observed after 24 and 48 hours respectively. All animals suffered from chemosis, but for all three this effect was only observed 1 hour after dosing. Treatment of the eyes with 2% fluorescein 24 hours after test item instillation revealed no corneal epithelial damage.
- Other effects:
- There were no signs of systemic toxicity, nor mortality, observed during the test period. The bodyweight of the animals was not reduced. There was no evidence of ocular corrosion.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Based on CLP criteria
- Conclusions:
- Under the conditions of this test, Spearmint Essential Oil, ex Mentha spicata does not need to be classified as eye irritant, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
- Executive summary:
To investigate the potential eye irritating effects of Spearmint Essential Oil, ex Mentha spicata, a study was conducted according to OECD 405. The test item was applied by instillation of 0.1 ml of the testsubstance into one eye of in total three New Zealand White rabbits. The ocular reactions observed included irritation of the conjunctivae (redness, chemosis and discharge). These effects were fully reversible within 4 days, 72 hours or 48 hours. No iridial irritation or corneal opacity were observed. Based on the results of this test it was concluded that Spearmint Essential Oil, ex Mentha spicata does not need to be classified as eye irritant, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
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