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EC number: 218-691-4 | CAS number: 2216-52-6
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Reproductive toxicity study
Data available for the read across chemicals was reviewed to determine the reproductive toxicity of (+)-neomenthol. NOAEL was considered to be 800 mg/kg bw for male and in range of 405.0- 671 mg/kg bw for female, when male and female rats or hamster were treated with test material orally by gavage. Thus, comparing this value with the criteria of CLP regulation(+)-neomenthol is likely to be not classify as reproductive toxicant.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- 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:
- Weight of evidence approach based on structurally similar chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mrentioned below
- Principles of method if other than guideline:
- WoE report is based on two reproductive toxicity studies on rats 1.Reproductive toxicity of test material in hamsters2.Subacute toxicity study of Menthone in Rats to evaluate its reprotoxic nature.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
- Species:
- other: 1.hamster 2.rat
- Strain:
- other: 1.Syrian 2.SPF
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Study 2.- Source: Mollegaards Breeding Centre Ltd., Ejby (DK-4623 L. Skensved).- Age at study initiation: 4 weeks old- Weight at study initiation:- Fasting period before study: not specified - Housing: The animals were kept in stainless steel wire cages (2 per cage)- Diet (e.g. ad libitum): The rats were fed a pelleted diet (Chow 101, Institute of Toxicology, and National Food Agency). ad libitum- Water (e.g. ad libitum): acidified water (citric acid, pH 3.5) was given ad lib.- Acclimation period:ENVIRONMENTAL CONDITIONS- Temperature (°C): 23’C ± 1°C,- Humidity (%): 60 % ± 5%- Air changes (per hr): air change 6-8 times/h,- Photoperiod (hrs): electric light from 21.00 to 09.00 hours
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- soya oil
- Details on exposure:
- Study 2.- Justification for use and choice of vehicle (if other than water): test material soluble in Soya oil - Concentration in vehicle: 0,200,400 and 800 mg/kgbw/ day
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Study 15 days Study 2.28 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
- Remarks:
- Study 1.4.05,21.15,98.2,405.0 mg/kg bw /dayStudy 2.0.0, 200.0,400.0 and 800.0mg/kg bw /day
- No. of animals per sex per dose:
- Study 2.Total: 800 (vehicle) mg/kg/day: 10 male, 10 female 200 mg/kg/day: 10 male, 10 female400 mg/kg/day: 10 male, 10 female800 mg/kg/day: 10 male, 10 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
- Parental animals: Observations and examinations:
- Study 1&2Survival, Clinical sign, hematological examinations,Body weight and weight gain and clinical chemistry were examined.
- Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Not specified
- Postmortem examinations (parental animals):
- Study 2.Organ weight and histopathology was examined.
- Postmortem examinations (offspring):
- Not specified
- Statistics:
- Study 2.Body weights, food and water consumption were compared by means of Student’s t-test. Analysis of variance was performed on haematoiogical parameters, clinical chemical parameters and absolute and relative organ weights. The mean values were compared by the method of Tukey.
- Reproductive indices:
- Not specified
- Offspring viability indices:
- Not specified
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Study 2.When treated wtih 800 mg/kg bw, after 19 days of dosing female rats showed signs of toxic effects. They had pale mucous membranes and showed signs of pain prevent deaths in this group, the dose was reduced to 400 mg/kg.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Study 1.No effect on survival of treated female hamsters were observed. Study 2.When treated wtih 800 mg/kg bw, 4 animals died during the study due to accidental intratracheal dosing.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Study 2.Decreased in body weight gain was observed in treated male and female rats at 200, 400 and 800 mg/kg bw as compared to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Study 2.When treated wtih 800 mg/kg bw, Decreased in food consumption was observed in treated male rat, and in female rats from 3rd week as compared to control. When treated with 200 and 400 mg/kg bw, Decreased in food consumption was observed in female rat within the first 2 weeks as compared to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Study 2.When treated with 800 mg/kg bw, dose-dependent decrease of creatinine concentration and a dose dependent increase of both alkaline phosphatase activity and bilirubin content were observed in treated male and female rats as compared to control.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Study 2.Cyst-like spaces appeared scattered in the white matter of the cerebellum at 800 mg/kg bw.The findings resembled the changes found in rats dosed with peppermint oil. No histopathological changes were observed in reproductive organ of testis and ovary of treated rats as compared to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Study 1.No effect on Reproductive performance of treated female hamsters was observed.
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- Remarks on result:
- other: No effect on histopathology of reproductive organs
- Dose descriptor:
- NOAEL
- Effect level:
- >= 405 - <= 671 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- reproductive performance
- Remarks on result:
- other: No effect on histopathology of reproductive organs and reproductive performance
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on fetal survival of treated female hamsters were observed.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No dose-related number of abnormalities in soft or skeletal tissues were observed in fetus of treated hamsters were observed.
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 405 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- mortality
- gross pathology
- other: not specified
- Remarks on result:
- other: No effects on developmental parameters was observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- NOAEL was considered to be 800 mg/kg bw for male and in range of 405.0- 671 mg/kg bw for female when male and female rats or hamster were treated with test material orally by gavage .
- Executive summary:
Study 1
In a Reproductive Toxicity study,Syrian female hamsters were treated with test material in the concentration of 4.05, 21.15, 98.2 and 405.0 mg/kg bw/day orally by gavage during gestation days 6-10. No effect on survival of treated female hamsters and fetus were observed. Similarly, No effect on Reproductive performance of treated female hamsters was observed.In addition, No dose-related number of abnormalities in soft or skeletal tissues were observed in fetus of treated hamsters were observed.Therefore, NOAEL was considered to be 405.0 mg/kg bw for P and F1 generation when Syrian female hamsters were treated with test material orally by gavage during gestation days 6-10.
Study 2.
In a repeated dose toxicity study,SPF male and female rats were treated with test material in the concentration of 0, 200, 400 and 800 mg/kg bw/ day orally by gavage for 28 days .At 800 mg/kg bw,after 19 days of dosing female rats showed signs of toxic effects. They had pale mucous membranes and showed signs of pain prevent deaths in this group, the dose was reduced to 400 mg/kg.4 animals died during the study due to accidental intratracheal dosing.Decreased in body weight gain was observed in treated male and female rats at 200, 400 and 800 mg/kg bw as compared to control. Decreased in food consumption was observed in treated male rat at 800 mg/kg bw, and in female rats from 3rd week at400 mg/kg bwas compared to control. Decreased in food consumption was observed in female rat within the first 2 weeks at 200 and 400mg/kg bwas compared to control. Dose-dependent decrease in creatinine concentration and a dose dependent increase of both alkaline phosphatase activity and bilirubin content were observed in treated male and female rats at 800 mg/kg bw as compared to control. Similarly,statistically significant dose-related increase in relative weight of the spleen, liver and brain of the male rat at 800 mg/kg bw and kidneys, spleen, liver and brain of female rats at 400 mg/kg bw were observed as compare to control. In addition, Cyst-like spaces appeared scattered in the white matter of the cerebellum at 800 mg/kg bw. The findings resembled the changes found in rats dosed with peppermint oil. No histopathological changes were observed in reproductive organ of testis and ovary of treated rats as compared to control. Therefore, NOAEL was considered to be 800 mg/kg bw for male and 671 mg/kg bw for female when SPF male and female rats were treated with test material orally by gavage for 28 days.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 405 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is Klimicsh 2 and from authoritative database
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity study
Data available from different studies were reviewed to determine the reproductive toxicity of(+)-neomenthol.The studies are as mentioned below:
Study 1
In a Reproductive Toxicity study, Syrian female hamsters were treated with test material in the concentration of 4.05, 21.15, 98.2 and 405.0 mg/kg bw/day orally by gavage during gestation days 6-10. No effect on survival of treated female hamsters and fetus were observed. Similarly, No effect on Reproductive performance of treated female hamsters was observed. In addition, No dose-related number of abnormalities in soft or skeletal tissues were observed in fetus of treated hamsters were observed. Therefore, NOAEL was considered to be 405.0 mg/kg bw for P and F1 generation when Syrian female hamsters were treated with test material orally by gavage during gestation days 6-10.
Study 2.
In a repeated dose toxicity study, SPF male and female rats were treated with test material in the concentration of 0, 200, 400 and 800 mg/kg bw/ day orally by gavage for 28 days .At 800 mg/kg bw, after 19 days of dosing female rats showed signs of toxic effects. They had pale mucous membranes and showed signs of pain prevent deaths in this group, the dose was reduced to 400 mg/kg.4 animals died during the study due to accidental intratracheal dosing. Decreased in body weight gain was observed in treated male and female rats at 200, 400 and 800 mg/kg bw as compared to control. Decreased in food consumption was observed in treated male rat at 800 mg/kg bw, and in female rats from 3rd week at400 mg/kg bwas compared to control. Decreased in food consumption was observed in female rat within the first 2 weeks at 200 and 400mg/kg bwas compared to control. Dose-dependent decrease in creatinine concentration and a dose dependent increase of both alkaline phosphatase activity and bilirubin content were observed in treated male and female rats at 800 mg/kg bw as compared to control. Similarly, statistically significant dose-related increase in relative weight of the spleen, liver and brain of the male rat at 800 mg/kg bw and kidneys, spleen, liver and brain of female rats at 400 mg/kg bw were observed as compare to control. In addition, Cyst-like spaces appeared scattered in the white matter of the cerebellum at 800 mg/kg bw. The findings resembled the changes found in rats dosed with peppermint oil. No histopathological changes were observed in reproductive organ of testis and ovary of treated rats as compared to control. Therefore, NOAEL was considered to be 800 mg/kg bw for male and 671 mg/kg bw for female when SPF male and female rats were treated with test material orally by gavage for 28 days
.
Based on the data available for the read across chemical, NOAEL was considered to be 800 mg/kg bw for male and in range of 405.0- 671 mg/kg bw for female when male and female rats or hamster were treated with(+)-neomentholorally by gavage. Thus, comparing this value with the criteria of CLP regulation(+)-neomentholis likely to be not classify as reproductive toxicant.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Thus, comparing this value with the criteria of CLP regulation (+)-neomenthol is likely to be not classify as reproductive toxicant.
Additional information
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.
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