Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
- 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
Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Mentha citrata, ext. (85085-49-0).The studies are as mentioned below:
1.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 2790 mg/kg bw.Death occurred within 4-18 hours after treatment. In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed.Hence,LD50 value was considered to be 2790 mg/kg bw(95% C. I.: 2440-3180 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.
2.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 14550 mg/kg bw.In clinical signs observations,animals showed depression soon after treatment, coma and wet posterior.Hence,LD50 value was considered to be14550 mg/kg bw(95 %C. I.: 12,300-17,170 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.
Thus, based on the above summarised studies,Mentha citrata, ext. (85085-49-0) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Mentha citrata, ext. (85085-49-0) cannot be classified for acute oral toxicity.Hence, based on the data available for the structurally similar read across, test chemical
Mentha citrata, ext. (85085-49-0) is not likely to be toxic at the dose of 14550 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- 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:
- data from handbook or collection of data
- Remarks:
- experimental data of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on two acute oral toxicity studies as-
1.and 2. Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents - GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material : Mentha citrata, ext.
- IUPAC name : Mentha citrata, ext.
- Molecular formula : Unspecified
- Molecular weight : Unspecified g/mol
- Substance type: Organic
- Physical state: Clear liquid (Colorless to slight yellow) - Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 1.Details on test animal
TEST ANIMALS
- Age at study initiation: young adult rats
- Fasting period before study:18 hours
- Diet (e.g. ad libitum): the food was replaced in cages as soon as the animals received their
respective doses.
- Water (e.g. ad libitum):water was provided ad libitum
2.Details on test animal
TEST ANIMALS
- Age at study initiation: young adult rats
- Fasting period before study:18 hours
- Diet (e.g. ad libitum): the food was replaced in cages as soon as the animals received their
respective doses.
- Water (e.g. ad libitum):water was provided ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data available
- Doses:
- 1.2790 mg/kg bw
2.14550 mg/kg bw - No. of animals per sex per dose:
- 1.Total: 10 animals
2790 mg/kg bw: 5 males and 5 females
2.Total: 10 animals
2790 mg/kg bw: 5 males and 5 females - Control animals:
- not specified
- Details on study design:
- 1.Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were maintained under close observation for toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks.
- Other examinations performed: clinical signs
2.Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were maintained under close observation for toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain.
- Other examinations performed: clinical signs - Statistics:
- LD50s were computed by the method of Litchfield & Wilcoxon (1949).
- Preliminary study:
- no data available
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 790 - < 14 550 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- 1.Death occurred within 4-18 hours after treatment.
2.50% mortality was observed at dose 14550 mg/kg bw - Clinical signs:
- 1.In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed
2.In clinical signs observations,animals showed depression soon after treatment, coma and wet posterior. - Body weight:
- No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
- Interpretation of results:
- other: not classified
- Conclusions:
- According to CLP regulation, the test chemical Mentha citrata, ext. (85085-49-0) cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw i.e. in the dose of 14550 mg/Kg bw.
- Executive summary:
Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Mentha citrata, ext. (85085-49-0).The studies are as mentioned below:
1.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 2790 mg/kg bw.Death occurred within 4-18 hours after treatment. In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed.Hence,LD50 value was considered to be 2790 mg/kg bw(95% C. I.: 2440-3180 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.
2.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 14550 mg/kg bw.In clinical signs observations,animals showed depression soon after treatment, coma and wet posterior.Hence,LD50 value was considered to be14550 mg/kg bw(95 %C. I.: 12,300-17,170 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.
Thus, based on the above summarised studies,Mentha citrata, ext. (85085-49-0) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Mentha citrata, ext. (85085-49-0) cannot be classified for acute oral toxicity.Hence, based on the data available for the structurally similar read across, test chemical
Mentha citrata, ext. (85085-49-0) is not likely to be toxic at the dose of 14550 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 14 550 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from peer-reviewed journal
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Mentha citrata, ext. (85085-49-0).The studies are as mentioned below:
1.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 2790 mg/kg bw.Death occurred within 4-18 hours after treatment. In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed.Hence,LD50 value was considered to be 2790 mg/kg bw(95% C. I.: 2440-3180 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.
2.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 14550 mg/kg bw.In clinical signs observations,animals showed depression soon after treatment, coma and wet posterior.Hence,LD50 value was considered to be14550 mg/kg bw(95 %C. I.: 12,300-17,170 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.
Thus, based on the above summarised studies,Mentha citrata, ext. (85085-49-0) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Mentha citrata, ext. (85085-49-0) cannot be classified for acute oral toxicity.Hence, based on the data available for the structurally similar read across, test chemical
Mentha citrata, ext. (85085-49-0) is not likely to be toxic at the dose of 14550 mg/kg bw.
Justification for classification or non-classification
Based on the above experimental studies on Mentha citrata, ext. (85085-49-0)and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Mentha citrata, ext. (85085-49-0)cannot be classified for acute oral toxicity.
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.