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EC number: 811-616-1 | CAS number: 1563063-07-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Jul - 17 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 Dec 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Essential oil of Mentha Spicata L., Erospicata (Labiatae) obtained from aerial parts by steam distillation
- EC Number:
- 811-616-1
- Cas Number:
- 1563063-07-9
- Molecular formula:
- not applicable for UVCB substances
- IUPAC Name:
- Essential oil of Mentha Spicata L., Erospicata (Labiatae) obtained from aerial parts by steam distillation
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD), SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 178.6 − 212.4 g
- Fasting period before study: overnight, approx. 16 h prior and 4 h after dosing
- Housing: 1 animal per cage in stainless wire mesh cages (260W x 350D x 210H mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS. Ltd., USA), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6 − 23.6
- Humidity (%): 49.0 - 70.3
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Lot/batch no.: MKBV2080V (SIGMA-ALDRICH, Co., USA)
MAXIMUM DOSE VOLUME APPLIED: 2.24 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance 2000 mg/kg bw was selected as starting dose. - Doses:
- 2000 mg/kg bw (step 1 and 2)
300 mg/kg bw (step 3 and 4) - No. of animals per sex per dose:
- 6 (3 per step)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min and 1, 2, 4 and 6 h after dosing and thereafter once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured in step 1 at 2000 mg/kg bw. In step 2 at 2000 mg/kg bw, one animal was found dead on Day 2 and 3. No mortality was observed at 300 mg/kg bw.
- Clinical signs:
- In surviving animals at 2000 mg/kg bw abnormal gait was observed in one animal 6 h after dosing and chromaturia (brown color) and/or decrease of fecal volume were observed in one to four animals on Day 1 and 2. The changes disappeared on Day 3. In dead animals abnormal gait and/or decrease in locomotor activity were observed in one to two animals at 4 and 6 h after dosing and chromaturia (brown color), decrease of fecal volume, lacrimation, loss of locomotor activity, lying on side, decrease in locomotor activity and/or soiled perineal region were observed in one to two animals on Day 1 and/or Day 2. The clinical signs were considered to be test substance-related.
No clinical abnormalities were observed at 300 mg/kg bw. - Body weight:
- In surviving animals at 2000 mg/kg bw a tendency for suppression of body weight gain was observed in three animals on Day 1 and a decrease in body weight was observed in one animal on Day 1 and Day 3. Normal body weight gains were observed in these animals on Day 3 and/or Day 7. In dead animals a decrease in body weight was observed on Day 1. The changes were considered to be test substance-related.
Normal body weight gains were observed in all animals at 300 mg/kg bw. - Gross pathology:
- No abnormal morphological findings were observed in any animal at 300 and 2000 mg/kg bw, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- other: Acute Tox. Cat. 4
- Remarks:
- according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study in rats a LD50 cut-off of 2000 mg/kg bw was determined.
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