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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
Endpoint summary
Administrative data
Description of key information
Skin sensitisation studies with cornmint oil (WoE, GPMT OECD 406): Sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data
- 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 - 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
- Positive control results:
- not applicable
- 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
- 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.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Identification data on test substance not reported. Results are acceptable as basic data.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson and Kligman guinea pig maximisation test (GPMT)
- Deviations:
- no
- Principles of method if other than guideline:
- not relevant
- 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
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal injection induction: 0.25 % test substance (suspended in physiological saline)
Topical application induction: 25% test substance (mixed with polyethylene glycol)
Challenge: 5% test substance - Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal injection induction: 0.25 % test substance (suspended in physiological saline)
Topical application induction: 25% test substance (mixed with polyethylene glycol)
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.
At every challenge in the test 4 previously untreated animals are treated exactly the same way as the test animals. - Positive control substance(s):
- no
- Positive control results:
- not applicable
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1 animal shows moderate erythema, 2 animals show very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1 animal shows moderate erythema, 2 animals show very faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1 animal shows moderate erythema, 1 animal shows very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1 animal shows moderate erythema, 1 animal shows very faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- 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: no reaction.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- 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: no reaction.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- other: untreated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 female showed small spots of erythema
- Remarks on result:
- other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: other: untreated negative control. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 female showed small spots of 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 shows 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 shows very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 3 animals show very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 2. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 3 animals show very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 3 animals show 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: 0.0. Total no. in groups: 10.0. Clinical observations: 3 animals show very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- 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 reaction.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- 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 reaction.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 female shows small spots of erythema
- 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: 1 female shows small spots of erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 female shows small spots of erythema
- 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: 1 female shows small spots of erythema.
- 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:
- 4 animals show very faint erythema, 2 animals show faint erythema, and 2 animals show moderate 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: 4 animals show very faint erythema, 2 animals show faint erythema, and 2 animals show moderate erythema.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- 1 animal shows very faint erythema, 1 animal shows faint erythema, and 2 animals show moderate 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: 3.0. Total no. in groups: 10.0. Clinical observations: 1 animal shows very faint erythema, 1 animal shows faint erythema, and 2 animals show moderate 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 male shows very faint 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 male shows very faint erythema.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- other: untreated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 2 males show very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: other: untreated negative control. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 2 males show very faint erythema.
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Cornmint oil (Peppermint Arvensis) did not have 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 Arvensis) 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 Arvensis, 1 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 not a sensitiser.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 11 May 1983 - 14 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.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- and polyethylene glycol
- Concentration / amount:
- Injection induction: test substance concentration of 0.25% suspended in physiological saline
Application induction: test substance concentration of 25% mixed with polyethylene glycol
Application challenge: test substance concentration of 5% - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- and polyethylene glycol
- Concentration / amount:
- Injection induction: test substance concentration of 0.25% suspended in physiological saline
Application induction: test substance concentration of 25% mixed with polyethylene glycol
Application challenge: test substance concentration of 5% - 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
- Positive control results:
- not applicable
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 4
- Total no. in group:
- 9
- Clinical observations:
- 2 animals showed moderate erythema, 2 animals showed faint erythema, 2 animals showed very faint erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 4.0. Total no. in groups: 9.0. Clinical observations: 2 animals showed moderate erythema, 2 animals showed faint erythema, 2 animals showed very faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- 1 animal showed moderate erythema, 2 animals showed faint erythema, 3 animals 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: 3.0. Total no. in groups: 9.0. Clinical observations: 1 animal showed moderate erythema, 2 animals showed faint erythema, 3 animals showed very faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- no reactions
- 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: 3.0. Clinical observations: no reactions.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- no reactions
- 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: 3.0. Clinical observations: no reactions.
- Reading:
- other: Challenge 1
- 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 1. . 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 1
- Hours after challenge:
- 48
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 2 animals 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: 2 animals showed very faint erythema.
- Reading:
- other: challenge 2
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- 1 animal showed faint erythema, 3 animals showed very faint erythema
- Remarks on result:
- other: Reading: other: challenge 2. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 9.0. Clinical observations: 1 animal showed faint erythema, 3 animals showed very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- 4 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: 0.0. Total no. in groups: 9.0. Clinical observations: 4 animals showed very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal showed small spots of erythema
- 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: 1 animal showed small spots of erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal showed small spots of erythema
- 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: 1 animal showed small spots of erythema.
- 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:
- 9
- Clinical observations:
- 1 animal showed marked erythema and necrosis, 3 animals showed faint erythema, 2 animals showed very faint erythema, 1 animal showed small spots of 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: 9.0. Clinical observations: 1 animal showed marked erythema and necrosis, 3 animals showed faint erythema, 2 animals showed very faint erythema, 1 animal showed small spots of erythema.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Clinical observations:
- 1 animal showed marked erythema and necrosis, 1 animal showed moderate erythema, 3 animals 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: 2.0. Total no. in groups: 9.0. Clinical observations: 1 animal showed marked erythema and necrosis, 1 animal showed moderate erythema, 3 animals 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:
- no reactions
- 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: no reactions.
- 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
- 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, 3 out of 9 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 restults of this test, the substance is a sensitiser.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 11 May 1983 - 22 July 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Identification data on test substance not reported. Results are acceptable as basic data.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson and kligman guinea pig maximisation test (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
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- and polyethylene glycol
- Concentration / amount:
- Injection induction solution: concentration of test substance 0.25% ,suspended in physiological saline.
Application indution solution: concentration of test substance 25%, mixed with polyethylene glycol.
Challenge: concentration of test substance: 5% - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- and polyethylene glycol
- Concentration / amount:
- Injection induction solution: concentration of test substance 0.25% ,suspended in physiological saline.
Application indution solution: concentration of test substance 25%, mixed with polyethylene glycol.
Challenge: concentration of test substance: 5% - 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
- Positive control results:
- not applicable
- 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:
- 3 animals show faint erythema, 2 animals show moderate 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: 3 animals show faint erythema, 2 animals show moderate 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:
- 2 animals show faint erythema, 2 animals show moderate erythema, 1 animal shows 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: 2 animals show faint erythema, 2 animals show moderate erythema, 1 animal shows very faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal shows 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 shows very faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal shows 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 shows very faint erythema.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- 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.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- 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.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- 2 animals show moderate erythema, 1 animal shows faint erythema, 3 animals show 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: 3.0. Total no. in groups: 10.0. Clinical observations: 2 animals show moderate erythema, 1 animal shows faint erythema, 3 animals show very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- 2 animals show faint erythema, 4 animals show 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: 2.0. Total no. in groups: 10.0. Clinical observations: 2 animals show faint erythema, 4 animals show very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal shows small spots of erythema
- 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: 1 animal shows small spots of erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- treated negative control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal shows very faint erythema
- 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: 1 animal shows very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal shows very faint erythema
- 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: 1 animal shows very faint erythema.
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- other: untreated negative controls
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal shows small spots pf erythema, 1 animal shows very faint erythema
- Remarks on result:
- other: see Remark
- Remarks:
- 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: 1 animal shows small spots pf erythema, 1 animal shows very faint erythema.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1 animal shows moderate erythema, 4 animals show very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 3. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1 animal shows moderate erythema, 4 animals show very faint erythema.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1 animal shows faint erythema, 2 animals show very faint erythema
- Remarks on result:
- other: Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1 animal shows faint erythema, 2 animals show 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 animal shows small spots of erythema, 1 animal shows very faint erythema
- Remarks on result:
- other: see Remark
- Remarks:
- 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 animal shows small spots of erythema, 1 animal shows very faint 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:
- 1 animal shows very faint erythema
- 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: 1 animal shows very faint erythema.
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Cornmint oil (Peppermint Chinese) 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 Chinese) 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 Chinese, 4 out of 10 test 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 study, the substance is a sensitiser.
Referenceopen allclose all
no data
no data
no data
no data
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Several studies on the skin sensitising potential of Cornmint oil were available for the dossier. Because of the comparable reliability between the studies and the differing outcomes, a Weight of Evidence approach was used to describe the endpoint of skin sensitisation.
Four guinea pig maximisation tests were available with different forms of cornmint oil, one using Peppermint Arvensis (65% Peppermint Brazilian and 35% Peppermint Chinese), one using Peppermint Chinese, and two using Peppermint Brazilian. In all tests three challenges with the test substance were performed. The first two challenges with Peppermint Arvensis indicated no skin sensitisation, only after three challenges sensitisation was indicated. The first challenge with Peppermint Chinese indicated skin sensitisation. However, the second and third challenge did not indicate skin sensitisation. In both studies conducted with Peppermint Brazilian, the first and third challenge indicated skin sensitisation.
Additionally tot the guinea pig maximisation tests, a human repeated occluded patch test was available which indicated allergic contact sensitisation in 2 out of 22 male subjects.
Based on the above information, it was concluded that Cornmint oil is a substance that possesses the ability to induce skin sensitisation. Three of the four animal studies indicated sensitisation and the human study indicated skin sensitisation in two subjects.
Migrated from Short description of key information:
Skin sensitisation (Weight of Evidence):
- GPMT (5% Peppermint Arvensis): not sensitising (method similar to OECD 406)
- GPMT (5% Peppermint Chinese): sensitising (method similar to OECD 406)
- GPMT (5% Peppermint Brazilian): sensitising (method similar to OECD 406)
- GPMT (5% Peppermint Brazilian): sensitising (method similar to OECD 406)
- Maximization test (humans): sensitising
Justification for selection of skin sensitisation endpoint:
No selection is made as a Weight of Evidence approach was followed which is described below.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, Cornmint oil needs to be classified for skin sensitisation when taking into account the criteria outlined in Annex VI of 1272/2008/EC and Annex I of 67/548/EEC.
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.