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EC number: 222-824-1 | CAS number: 3623-51-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Missing: purity of substance, information on housing conditions, sufficient details of the administration scheme, statistical details
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- food consumption not reported; uterine weights and corpora lutea not determined; one third used for visceral examination; test substance identification missing; administration only during periods of organogenesis, no statistics, no historical data
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- L-menthol
- EC Number:
- 218-690-9
- EC Name:
- L-menthol
- Cas Number:
- 2216-51-5
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1R,2S,5R)-2-isopropyl-5-methyl-cyclohexanol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Dose: 0; 2.18; 10.15; 47.05; 218 mg/kg bw/day
administered as a corn oil solution.
The controls were sham treated with the vehicle at a level equivalent to the group receiving the highest test dose. Beginning on day 6 after gestation and continuing daily through day 15 of gestation, the females were dosed with the indicated dosages by oral intubation. - Details on mating procedure:
- Virgin adult were mated with young adult males (observation of the vaginal sperm plug was considered Day 0 of gestation)
- Duration of treatment / exposure:
- gestation days 6-15
- Frequency of treatment:
- daily
- Duration of test:
- 10 consecutive days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2.18 mg/kg bw/day
- Dose / conc.:
- 10.15 mg/kg bw/day
- Dose / conc.:
- 47.05 mg/kg bw/day
- Dose / conc.:
- 218 mg/kg bw/day
- No. of animals per sex per dose:
- 25 females per dose
No of pregnant animals (0; 2.18; 10.15; 47.05; 218 mg/kg bw/day): 25, 22, 23, 23, 22 - Control animals:
- yes, concurrent vehicle
- other: positive control: Aspirin 250 mg/kg bw/day
Examinations
- Maternal examinations:
- Body weights were recorded on day 0, 6, 11, 15, and 20 of gestation. All animals were observed daily for appearance and behavior with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animal
- Ovaries and uterine content:
- On day 20 all dams were subjected to Caesarian section under surgical anesthesia, and the numbers of implantation sites, resorption sites, and live and dead fetuses were recorded. The body weights of the live pubs were also recorded. The urogenital tract of each dam was examined in detail for anatomical normality.
- Fetal examinations:
- All fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses of each litter underwent detailed visceral examinations employing 10x magnification. The remaining two-thirds were cleared in potassium hydroxide (KOH), stained with alizarin red S dye and examined for skeletal defects.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects: no effects
Details on maternal toxic effects:
No clinical signs of maternal toxicity
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- > 218 mg/kg bw/day
- Based on:
- not specified
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: no effects
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- > 218 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: teratogenicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOEL
- Effect level:
- > 218 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Fetotoxicity:
· Death: no dead fetuses in dosage groups (3 deaths in positive control)
· Average fetus weight: no change in treated groups compared to controls
· Abnormalities/malfunctionsa)sham control; b)pos. control; c)2.18; d)10.15; e)47.05; f)218 mg/kg bw/day
o Skeletal findingsNo. of fetuses/No. of litters affected:
§ sternebrae (incomplete oss.): a)80/22; b)94/18; c)92/20; d)93/22; e)101/19; f)92/19
§ sternebrae (missing): a)14/6; b)11/19; c)11/8; d)17/5; e)11/4; f)0/22
§ skull (incomplete closure): a)41/16; b)114/19; c)46/15; d)63/16; e)67/20; f)49/17
o Soft tissue abnormalities:
§ pos. control: 7 pups with meningoencephalocele and spina bifida
§ 10.15 mg/kg: 1 pup: petechiae, 1 pup: anophthalmia
§ 47.05 mg/kg: 2 pups anophthalmia, 2 pups: gastroschisis,1 pup hydrocephalus
o All other findings:
§ were completely in the range of spontaneous abnormalities found in negative controls.
Applicant's summary and conclusion
- Conclusions:
- Menthol was not embryo- or fetotoxic and had no teratogenic properties in rat at non-maternally toxic doses (218 mg/kg bw/day).
- Executive summary:
The administration of up to 218 mg/kg bw/day of L-menthol to pregnant rats for 10 consecutive days had no clearly discernible effects on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham treated controls.
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