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EC number: 290-058-5 | CAS number: 90063-97-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Mentha arvensis, 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 11 May 1983 - 6 July 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Information on test substance identity not reported. Results acceptable as basic data.
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:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson and Kligman GPMT
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing study, performed before LLNA was available as OECD guideline
Test material
- Reference substance name:
- cornmint oil
- IUPAC Name:
- cornmint oil
- Details on test material:
- - Name of test material (as cited in study report): Peppermint Brazilian
- Substance type: processed essential oil
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- and polyetylene glycol
- Concentration / amount:
- Injection induction: 0.25% test substance suspended in physiological saline
Application induction: 25% test substance mixed with polyethylene glycol
Application challenge: 5% test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- and polyetylene glycol
- Concentration / amount:
- Injection induction: 0.25% test substance suspended in physiological saline
Application induction: 25% test substance mixed with polyethylene glycol
Application challenge: 5% test substance
- No. of animals per dose:
- 10
- Details on study design:
- no data
- Challenge controls:
- During the first and second challnge, four control animals are selected as treated controls. The receive four intradermal injections of 50% FCA in the test solvent followed seven days later by a 48 hour occluded patch of the test solvent over the injection sites. The four guinea pigs are challenged with the test substance in exactly the same way as the test animals at both the first and second challenge.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- 1 animals showed moderate erythema, 4 animals showed faint erythema
- Remarks on result:
- other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: 1 animals showed moderate erythema, 4 animals showed faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- 4 animals showed faint/moderate erythema, 1 animal showed very faint erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 4 animals showed faint/moderate erythema, 1 animal showed very faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal showed very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: other: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal showed very faint erythema.
- Remarks:
- treated negative control
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal showed very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: other: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal showed very faint erythema.
- Remarks:
- treated negative control
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal showed very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal showed very faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal showed very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal showed very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- 1 animal showed moderate erythema, 4 animals showed faint erythema, 2 animals showed very faint erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Challenge 2. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: 1 animal showed moderate erythema, 4 animals showed faint erythema, 2 animals showed very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- 5 animals showed faint erythema, 3 animals showed very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 2. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: 5 animals showed faint erythema, 3 animals showed very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reactions
- Remarks on result:
- other: Reading: other: Challenge 2. . Hours after challenge: 24.0. Group: other: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reactions.
- Remarks:
- treated negative control
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reactions
- Remarks on result:
- other: Reading: other: Challenge 2. . Hours after challenge: 48.0. Group: other: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reactions.
- Remarks:
- treated negative control
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reactions
- Remarks on result:
- other: Reading: other: Challenge 2. . Hours after challenge: 24.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reactions.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reactions
- Remarks on result:
- other: Reading: other: Challenge 2. . Hours after challenge: 48.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reactions.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- 1 animal showed moderate erythema, 3 animals showed faint erythema, 5 animals showed very faint erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Challenge 3. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 1 animal showed moderate erythema, 3 animals showed faint erythema, 5 animals showed very faint erythema.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- 3 animals showed moderate erythema, 2 animals showed faint erythema, 1 animal showed very faint erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: 3 animals showed moderate erythema, 2 animals showed faint erythema, 1 animal showed very faint erythema.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 24
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animals showed small spots of erythema
- Remarks on result:
- other: Reading: other: Challenge 3. . Hours after challenge: 24.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animals showed small spots of erythema.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reactions
- Remarks on result:
- other: Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reactions.
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Cornmint oil (Peppermint Brazilian) had sensitising properties in the GPMT-test, under the conditions of this test.
- Executive summary:
In a GPMT-test, the sensitising properties of Cornmint oil were investigated. Guinea pigs were induced by intradermal injections of both test substance (Peppermint Brazilian) and FCA. Seven days later the induction was boosted by an occluded patch placed over the injection site. 14 days later the animals were challenged by occluded patch: further challenges were made at weekly intervals as required.
After 1 challenge with 5% Peppermint Brazlilian, 4 out of 10 animals showed sensitisation. In this study an adjuvant is used for induction of sensitization. At least 30% of the animals have to be considered positive to classify the substance as a (mild/moderate) skin sensitizer (Annex I of 1272/2008/EC and Annex VI of EU Directive 67/548/EEC). Therefore, according to the results of this test, the substance is a sensitiser.
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