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EC number: 282-015-4 | CAS number: 84082-70-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Mentha piperita, 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 November 1988 - 8 November 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted under GLP conditions and according to a reliable method, but not an official guideline. The study report is well-documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no functional observations
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- B100
- IUPAC Name:
- B100
- Reference substance name:
- Peppermint oil
- IUPAC Name:
- Peppermint oil
- Details on test material:
- - Name of test material (as cited in study report): B100
- Physical state: Liquid
- Storage condition of test material: Protected from light in an amber jar under refrigeration
- Composition of test material, percentage of components: confidential information
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, North Carolina, USA
- Age at study initiation: 6 weeks
- Weight at study initiation:
Males: 198.4 - 226.1
Females: 139.3 - 170.5
- Housing: Individually
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 25.6
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test material was weighed into a pre-calibrated beaker on an appropriate balance. Corn oil was added to achieve appropriate volume and stirred for 2-3 minutes. Test mixtures were prepared fresh weekly.
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Amount of vehicle (if gavage): 10 ml/kg
- Lot/batch no. (if required): BG 1314 - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 200, 400 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: No data
- Rationale for animal assignment: At random
- Section schedule rationale: Two-day period, fifty-fifty sacrificed and necropsied over the two days. - Positive control:
- Not relevant
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS:
- Time schedule: Twice daily
- Cage side observations: mortality and moribundity
DETAILED CLINICAL OBSERVATIONS:
- Time schedule: Weekly
BODY WEIGHT:
- Time schedule for examinations: Weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined as g food/week.
HAEMATOLOGY:
- Time schedule for collection of blood: Prior to intitation of study and at termination
- Anaesthetic used for blood collection: Yes (ketamine)
- Animals fasted: Yes, overnight
- How many animals:
Prior to initiation: 10 healthy animals not selected for study
At termination: all surviving animals
- Parameters checked: corrected leukocyte count, leukocyte count, erythrocyte count, hemoglobin, hematocrit, platelet count, leukocyte differential count cell morphology, myeloid/erythroid ratio.
CLINICAL CHEMISTRY:
- Time schedule for collection of blood: Prior to intitation of study and at termination
- Anaesthetic used for blood collection: Yes (ketamine)
- Animals fasted: Yes, overnight
- How many animals:
Prior to initiation: 10 healthy animals not selected for study
At termination: all surviving animals
- Parameters checked: sodium, potassium, chloride, total protein, albumin, calcium, total carbon dioxide, total bilirubin, blood urea nitrogen, creatinine, glucose, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, alkaline phosphatase. - Sacrifice and pathology:
- GROSS PATHOLOGY: Necropsy was performed on all surviving animals and the following was examined: external surfaces, all orifices, cranial cavity, external surface of the brain (external surface of the spinal cord and the cut surfaces of the brain and spinal cord were examined at the time of tissue trimming), nasal cavity and paranasal sinuses, thoracic, abdominal and pelvic cavities and their viscera, cervical tissues and organs.
ORGAN WEIGTHS: Organ weights of the following organs were measured for each sacrificed animal: brain (including brainstem), spleen, liver, heart, kidneys, testes with epididymides, thyroid with parathyroids, adrenals, ovaries, pituitary.
HISTOPATHOLOGY: The following tissues were examined from all control and high-dose animals: femoral bone marrow, lung (with mainstem bronchi), ovaries, gross lesions, kidneys, adrenals, testes with epididymides, duodenum and jejunum and ileum, brain with brainstem (medulla/pons, cerebellar cortex, cerebral cortex), pancreas, urinary bladder, pituitary, uterus, thyroid (parathyroids), heart, liver, spleen, colon and cecum and rectum, stomach, mesenteric lymph node. From the low and middose group only the heart, liver, kidneys and gross lesions were examined microscopically. - Other examinations:
- None performed.
- Statistics:
- ANOVA was used to determine significant differences in parameters between the test groups.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortality was observed. An increase in urine stains was observed for the high-dose males as compared to the other test groups.
BODY WEIGHT AND WEIGHT GAIN
No significant differences in body weight (gain) were observed.
FOOD CONSUMPTION
No significant differences in food consumption were observed.
HAEMATOLOGY
A significant decrease in myeloid/erythroid ratio was observed for the high-dose males as compared to the control group.
CLINICAL CHEMISTRY
A significant decrease in glucose levels was observed for the high and mid-dose males as compared to the control group. A significant increase in alkaline phosphatase levels was observed for the high-dose group.
ORGAN WEIGHTS
A significant increase in absolute and relative liver weight was observed for females of the high-dose group as compared to the controls. Relative kidney weight was significantly higher for the high-dose males.
GROSS PATHOLOGY
An increased, non-significant, incidence in stomach dark area's was seen for the male dose groups as compared to control. This effect was also seen in the female groups, including the control group.
HISTOPATHOLOGY: NON-NEOPLASTIC
Histopathological changes (chronic inflammation, regeneration of tubules, droplets in tubule cells) in the kidney were observed for the male dose groups and not in the control group. This is supported by the increase in relative kidney weight. The observed effects consisted of renal tubular protein droplets, thought to be related to lysosomal handling of alpha-2-µ globulin. This effects is a known male-specific effect in rats caused by exposure to hydrocarbons.
For females, the same changes were found as compared to controls, but to a lesser extent and no droplets were observed in the tubule cells. The differences in relative and absolute liver weight in the female high-dose group were not supported by histopathology. No other remarkable histopathological differences between control and test groups were noted.
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Histopathological changes (kidney) in all dose group: renal tubular protein resorption droplets (male-rat specific)
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No observed adverse effects.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No gross necrospy, organ weight and/or histopathological effects were observed for the brain stem (incl. medulla/pons, cerebellar cortex and cerebral cortex). No indication for neurotoxicity was found.
The individual result tables do not provide additional information on the effects that were observed (hematology, clinical chemistry, organ weights and histopathology).
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, no treatment related considered effects were noted in females. In all male dose groups treatment related kidney effects were observed, resembling the male rat-specific effect hyalin droplet nephropathy. Based on these findings, the NOAEL for females was established to be 400 mg/kg bw/day, while for males a LOAEL of 100 mg/kg bw/day was found based on male rat-specific effects.
- Executive summary:
Rats were exposed to the substance B100 for 28 days by gavage. Animals were observed for mortality, moribundity, body weight and food consumption. Additionally, several hematology and clinical chemistry parameters were studied and gross necropsy, organ weight measurements and histopathology were performed.
No mortality was observed in the study. An increase in urine stains was observed for the high-dose males as compared to the other test groups. No significant differences in body weight (gain) and food consumption were observed. A significant decrease in myeloid/erythroid ratio and increase in alkaline phosphatase was observed for the high-dose males and a significant decrease in glucose levels was observed for the high and mid-dose males as compared to the control group.
A significant increase in absolute and relative liver weight was observed for females of the high-dose group as compared to the controls. Relative kidney weight was significantly higher for the high-dose males. An increased, non-significant, incidence in stomach dark area's was seen for the male dose groups as compared to control. This effect was also seen in the female groups, including the control group.
Histopathological changes (chronic inflammation, regeneration of tubules, droplets in tubule cells) in the kidney were observed for the male dose groups and not in the control group. This is supported by the increase in relative kidney weight. The observed effects consisted of renal tubular protein droplets, thought to be related to lysosomal handling of alpha-2-µ globulin. This effects is a known male-specific effect in rats caused by exposure to hydrocarbons. The differences in relative and absolute liver weight in the female high-dose group were not supported by histopathology. No other remarkable histopathological differences between control and test groups were noted.
Under the conditions of this study, no treatment related considered effects were noted in females. However, in all male dose groups treatment related kidney effects were observed. Based on these findings, the NOAEL for females was established to be 400 mg/kg bw/day, while for males a LOAEL of 100 mg/kg bw/day was found.
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