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
Skin Irritation:
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 extract will also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be irritating to skin. It can be classified under the category “Category 2” as per CLP regulation.
Eye Irritation:
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 extract will also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be irritating to eyes. It can be classified under the category “Category 2” as per CLP regulation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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
- 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 irritation potential of Mentha citrata, ext.
- GLP compliance:
- 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) - Details on test animals or test system and environmental conditions:
- no data available
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 1. 5 g/kg
2. undiluted
3. undiluted - Duration of treatment / exposure:
- 1. 24 hours
2. 4 hours
3. not specified - Observation period:
- 1. 24 hours
2. 4 hours
3. not specified - Number of animals:
- 1. 6
2. 10
3. 10 - Details on study design:
- The study is based on weight of evidence approach from the read across values
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- signs of irritation observed
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- 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 extract will also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be irritating to skin. It can be classified under the category “Category 2” as per CLP regulation.
- Executive summary:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of Mentha Citrata ext.
The dermal irritation potential of the structurally similar chemical was evaluated as a part of an acute dermal LD50 study.5 g/kg of the undiluted material was applied under occlusion to the skin of 10 guinea pigs for 24 hours and observed for effects. Slight to moderate erythema or edema was observed on guinea pigs skin after 24 hours.
Hence, the test chemical can be considered to be irritating to guinea pig skin.
This is supported by the results of a patch test performed to assess the dermal irritation potential of other structurally similar chemical.
100% undiluted test chemical was under semi occlusive conditions to the skin of 6 female New Zealand white rabbits for 4 hours. The rabbits were observed and scored for erythema and edema.
The erythema and edema scores were 2.0 and 1.4 respectively. Based on the scores, the test chemical was considered to be irritating to skin.
The above studies are supported by the results of another study performed to assess the irritation potential of another structurally similar chemical. The study was conducted as part of an acute dermal study. Undiluted test chemical was applied to the skin of 10 rabbits and observed for effects (duration of exposure, observation period not mentioned).
Slight to moderate irritation was observed. Hence, the test chemical was considered to be irritating to skin.
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 extract will also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be irritating to skin. It can be classified under the category “Category 2” as per CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of Mentha Citrata ext.
The dermal irritation potential of the structurally similar chemical was evaluated as a part of an acute dermal LD50 study.5 g/kg of the undiluted material was applied under occlusion to the skin of 10 guinea pigs for 24 hours and observed for effects. Slight to moderate erythema or edema was observed on guinea pigs skin after 24 hours.
Hence, the test chemical can be considered to be irritating to guinea pig skin.
This is supported by the results of a patch test performed to assess the dermal irritation potential of other structurally similar chemical.
100% undiluted test chemical was under semi occlusive conditions to the skin of 6 female New Zealand white rabbits for 4 hours. The rabbits were observed and scored for erythema and edema.
The erythema and edema scores were 2.0 and 1.4 respectively. Based on the scores, the test chemical was considered to be irritating to skin.
The above studies are supported by the results of another study performed to assess the irritation potential of another structurally similar chemical. The study was conducted as part of an acute dermal study. Undiluted test chemical was applied to the skin of 10 rabbits and observed for effects (duration of exposure, observation period not mentioned).
Slight to moderate irritation was observed. Hence, the test chemical was considered to be irritating to skin.
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 extract will also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be irritating to skin. It can be classified under the category “Category 2” as per CLP regulation.
Eye Irritation:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of Mentha Citrata ext.
The ocular irritation potential of the structurally similar read across chemical was assessed in rabbits.
100% undiluted test chemical was instilled into the eyes of rabbits and observed for signs of irritation. (duration of exposure, observation period not mentioned). Very slight irritation was observed when undiluted test chemical was instilled into rabbit eyes.
Hence, the test chemical was considered to be irritating to eyes.
This is supported by the results of another experimental study performed to determine the degree of ocular damage caused by other structurally similar chemical.
100% undiluted test chemical was instilled into the eyes of rabbits and observed for signs of irritation. (duration of exposure, observation period not mentioned).
Moderate irritation to the eyes was observed when undiluted test chemical was instilled into rabbit eyes.
Hence, the test chemical was considered to be irritating to eyes.
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded thatMentha 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 irritating to eyes. It can be classified under the category “Category 2” as per CLP regulation.
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 irritating to skin and eyes.
Hence by applying the weight of evidence approach, Mentha citrata, ext. can be considered to be irritating to skin and eyes. It can be classified under the category “Category 2” as per CLP regulation.
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