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EC number: 282-015-4 | CAS number: 84082-70-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Mentha piperita, Labiatae.
- 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

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across to cornmint oil. Test was performed as described by Kligman (1966) but not according to GLP. Limited details on test subjects and used methods available.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Kligman, JID 47: 393-409, 1966
- Principles of method if other than guideline:
- no data
- GLP compliance:
- no
- Remarks:
- pre-GLP test
Test material
- Reference substance name:
- Cornmint oil
- IUPAC Name:
- Cornmint oil
- Details on test material:
- no data
Constituent 1
Method
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 22 volunteers completed the experiment
- Sex: male
- Age: no data
- Race: Black (1), Mexican (7), Caucasian (13), Chinese (1)
- Demographic information: no data - Clinical history:
- No data on the clinical history of the subjects. According to the study report the volunteers were all healthy at the start of the study.
- Controls:
- Petrolatum control on right side of the back.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: no data
- Vehicle / solvent: unchanged (no vehicle)
- Concentrations: no data
- Volume applied: no data
- Testing/scoring schedule:
Test material was applied under occlusion to the same sites on the volar aspect of the forearms of all subjects for 5 alternate day 48 periods. Patch sites were pretreated for 24 hours with 5% aqeous SLS under occlusion for the initial patch only. Following a 10 to 14 day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 1 hour exposure of 1% aqeous SLS under occlusion on the left side of the back, whereas the test material was applied without SLS treatment on the right side and an additional petrolatum control was placed on the right.
- Removal of test substance: Patches were removed and read after 24 hours and in some instances after 96 hours.
- Other: Some questionable reactions were biopsied and retests were applied one week later on fresh sites to reevaluate any questionable reaction.
EXAMINATIONS
- Grading/Scoring system: no data
- Statistical analysis: no data
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: Test material produced questionable reactions in two subjects at sites pretreated with SLS. In one subject the test material produced a definite positive reaction at the test site pretreated with SLS.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 19
- Number of subjects with equivocal reactions: 2
- Number of subjects with irritating reactions: 0
OTHER RESULTS: Biopsies were obtained from one subject showing a questionable reaction and from the subject showing a positive reaction. The results of the biopsies indicated allergic contact sensitization in the two subjects. The other subject, showing questionable reactions, refused biopsy.
One week later, the test material was retested in the two subjects showing questionable reactions. The retest revealed increased reactivity in one subject (who cooperated with the biopsy), substantiating the fact that he was allergic to the test material. In the other subject (who refused the biopsy) the reaction again appeared questionable or irritant in nature and he was considered not to have become sensitized by the material.
The test material induced allergic reactions in two out of 22 male volunteers.
Any other information on results incl. tables
There was very little irritation at the 1% SLS treated site.
Applicant's summary and conclusion
- Conclusions:
- In a human maximisation test, two out of 22 volunteers showed sensitising reactions. This indicates that the test substance can induce a substantial positive skin sensitisation reaction in human. For this reason cornmint oil can be considered a skin sensitiser.
- Executive summary:
The sensitising properties of Cornmint oil were investigated in a human maximisation test. Twenty-two healthy male volunteers completed the experiment. The test material was applied under occlusion to the forearms of all subjects for 5 alternate day 48 hour periods. SLS was used as pre-treatment. Following a 10 to 14 day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours, both with and without pretreatment of SLS, and an additional petrolatum control was applied. The challenge sites were read on removal of the patch 24 upto 96 hours later. Some questionable reactions were biopsied and, when needed, retests were applied one week later.
The test material produced a definite positive reaction in one subjec (#26) at the SLS treated site and questionable reactions at the SLS treated sites in two subjects (#10 and #22). Biopsies - from subject #22 and #26 - indicated allergic contact sensitistion. Retests in subject #10 and #22 showed increased reactivity in subject #22 and in subject #10 the reactions again appeared questionable or irritant in nature. He was considered not to have become sensitized by the test material.
The results indicate that the test substance can induce a positive skin sensitisation reaction in human. According to the criteria outlined in Annex I of 1272/2008/EC, Cornmint oil may be classified as skin sensitiser based on the fact that a substantial (10%) positive response is seen in human subjects.
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.
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