Registration Dossier
Registration Dossier
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EC number: 285-378-7 | CAS number: 85085-49-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Mentha citrata, Labiatae.
Endpoint summary
Administrative data
Description of key information
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that Mentha citrata extractwill also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be not sensitizing to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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: Weight of evidence approach based on structurally similar chemicals
- Justification for type of information:
- Weight of evidence approach based on structurally similar chemicals
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on structurally similar chemicals
- Principles of method if other than guideline:
- The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization potential of Mentha citrata extract
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on structurally similar chemicals
- Justification for non-LLNA method:
- not specified
- Specific details on test material used for the study:
- - Name of test material: Mentha citrata, ext.
- IUPAC name: Mentha citrata, ext.
- Molecular formula: C10H18O (Linalool) or C12H20O2 (Linalyl acetate)
- Molecular weight: 154.251- 196.288 g/mol
- Substance type: Organic
- Physical state: Clear liquid (Colorless to pale yellow) - Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data available
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 8%, 20%
- Day(s)/duration:
- 4 weeks
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 8%, 20%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- no data available
- Details on study design:
- The study is based on weight of evidence approach from the read across values
- Challenge controls:
- The study is based on weight of evidence approach from the read across values
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 8% ,20%.
- Clinical observations:
- no signs of dermal sensitization observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensiting
- Conclusions:
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that Mentha citrata extractwill also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be not sensitizing to skin.- Executive summary:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of Mentha citrate extract.
An Open Epicutaneous Test (OET) was performed on guinea pigs to assess the skin sensitization potential of the structurally similar chemicals.
The pretest was performed to determine the primary irritating threshold concentration of test substances at various concentrations (e.g, 100, 30, 10 and 3%). In this test, a single application of 0.025 ml of each test concentration was simultaneously performed on one of the areas measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp. Reactions are read 24 h after the application of the test material. On the basis of pretest, the concentration selected for sensitization test was 8% for the first one and 20% for the second one.
On day 1 during induction, 0.1 ml of 8%, 20% of the structurally similar chemicals were applied to an area measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, can be read 24 h after each application, or at the end of each week. To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days, as well as 10 untreated, or only pretreated with the vehicle, controls are tested on days 21 and 35 on the contralateral flank with the test material. This test was performed by applying with a pipette 0.025 ml of chemical to skin areas measuring 2 cm2. The reactions were read after 24, 48 and/or 72h.
It was observed that none of the guinea pigs induced contact sensitization at challenge concentration of 8%, 20%.
Both the structurally similar chemicals were considered to be not sensitizing on skin of guinea pigs when tested via an Open Epicutaneous Test (OET).
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that Mentha citrata extractwill also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be not sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of Mentha citrate extract.
An Open Epicutaneous Test (OET) was performed on guinea pigs to assess the skin sensitization potential of the structurally similar chemicals.
The pretest was performed to determine the primary irritating threshold concentration of test substances at various concentrations (e.g, 100, 30, 10 and 3%). In this test, a single application of 0.025 ml of each test concentration was simultaneously performed on one of the areas measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp. Reactions are read 24 h after the application of the test material. On the basis of pretest, the concentration selected for sensitization test was 8% for the first one and 20% for the second one.
On day 1 during induction, 0.1 ml of 8%, 20% of the structurally similar chemicals were applied to an area measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, can be read 24 h after each application, or at the end of each week. To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days, as well as 10 untreated, or only pretreated with the vehicle, controls are tested on days 21 and 35 on the contralateral flank with the test material. This test was performed by applying with a pipette 0.025 ml of chemical to skin areas measuring 2 cm2. The reactions were read after 24, 48 and/or 72h.
It was observed that none of the guinea pigs induced contact sensitization at challenge concentration of 8%, 20%.
Both the structurally similar chemicals were considered to be not sensitizing on skin of guinea pigs when tested via an Open Epicutaneous Test (OET).
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that Mentha citrata extractwill also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be not sensitizing to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the experimental studies from the structurally similar chemicals indicate a possibility that Mentha citrata, ext. can be not sensitizing to skin.
Hence by applying the weight of evidence approach, Mentha citrata, ext. can be considered to be not sensitizing to skin.
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