Registration Dossier
Registration Dossier
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: 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented and conducted similarly to OECD Guideline 414 with deviations: mating conditions (1 male for 3 females); food consumption not followed; bodyweight only recorded at Day 0, 6, 16 and 20 of gestation
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Study on embryo-foetotoxicity of beta-myrcene in the rat
- Author:
- Delgado, I.F., Carvalho, R.R., Nogueira, A.C., Mattos, A.P., Figueiredo, L.H., Oliveira, S.H., Chahoud, I., Paumgartten, F.J.
- Year:
- 1 993
- Bibliographic source:
- Food Chem Toxicol. 1993 Jan;31(1):31-5
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- mating conditions (1 male for 3 females); food consumption not followed; bodyweight only recorded at Day 0, 6, 16 and 20 of gestation
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- 7-methyl-3-methyleneocta-1,6-diene
- EC Number:
- 204-622-5
- EC Name:
- 7-methyl-3-methyleneocta-1,6-diene
- Cas Number:
- 123-35-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 7-Methyl-3-methyleneocta-1,6-diene
- Details on test material:
- - Name of test material (as cited in study report): β-Myrcene
- Source: Sigma Chemical Co., St Louis, MO, USA
- Analytical purity: 90%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Oswaldo Cruz Foundation Central Animal House breeding stock
- Housing: Housed in plastic cages with wood shavings as bedding
- Diet (e.g. ad libitum): Nuvital diet for laboratory animals, Nuvilab Ltd, Curitiba, Brazil; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 °C
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test material was dissolved in corn oil
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable
- Details on mating procedure:
- - Impregnation procedure: Cohoused
- If cohoused:
- M/F ratio per cage: 1:3
- Length of cohabitation: 2 h
- Proof of mating: Sperm in vaginal smear referred to as Day 0 of pregnancy - Duration of treatment / exposure:
- 10 days (Day 6-15 of pregnancy)
- Frequency of treatment:
- Once daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500 and 1200 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Treated females: 22-36; pregnant females: 16-29
- Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
- Details on study design:
- Control animals: as no statistically significant difference was found between the untreated and the vehicle treated control animals, in any of the parameters analysed, the data of both groups were pooled and were thereafter designated the control group.
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 16 and 20 of pregnancy - Ovaries and uterine content:
- The uterine content was examined after termination: Yes, animals were sacrificed on Day 20 for caesarean examinations
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of living and dead foetuses: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes [all living foetuses]; weighed and examined for externally visible malformations
- Soft tissue examinations: Yes [5-7 litters per group]: evaluated for visceral malformations; heart, lungs, thymus, liver, spleen and kidneys were weighed and microdissected
- Skeletal examinations: Yes [all the remaining litters] - Statistics:
- - Statistical analysis was by one way analysis of variance or, alternatively, by the Kruskal-Wallis test whenever the data did not fit a normal distribution
- Statistically significant differences between groups were tested by using a two sided Student's t-test or the Mann-Whitney U-test
- Proportions were analysed by the chi-square test
- Difference was considered to be statistically significant at P < 0.05 - Indices:
- No data
- Historical control data:
- No
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
At 250 and 500 mg/kg bw /day: No treatment-related effects
At 1200 mg/kg bw/day:
- Mortality: 1/29 dams died on Day 11 of pregnancy
- Body weights: Statistically significant decrease in weight gain during days 6-11 of pregnancy (17.3 ± 7 g vs. 3.2 ± 13.2 g in control vs. 1200 mg/kg group, respectively)
- Cesarean examination: Number of visible implantation sites was significantly reduced (12.6 ± 2.2 vs. 10.2 ± 2.9 in control vs. 1200 mg/kg group, respectively)
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
- Body weight: Treatment-related effects on foetal weight were only very slight, or even insignificant, if the litter is taken as the statistical unit of analysis
- External examinations: Increased frequency of irregularly positioned hind paws was observed in 1200 mg/kg bw/day group
- Visceral examinations: Visceral malformations such as enlarged ureters associated with an enlarged renal pelvis (one control foetus and one in 1200 mg/kg group), shorter ureter (one control foetus and one in 250 mg/kg bw/day group) and accessory (seventh) lobe in the liver (three foetus in 250 mg/kg bw/day group)
- Skeletal examinations: Increased incidence of delayed ossification and minor gross structural anomalies in the foetal skeleton were observed in 1200 mg/kg bw/day group
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1 . Occurrence of delayed ossification in foetuses of rats treated orally with β-myrcene on Days 6-15 of pregnancy
|
β-Myrcene (mg/kg bw) |
|||
Treatment |
0 |
250 |
500 |
1200 |
Foetuses examined (no.) |
114 |
106 |
116 |
209 |
Percentage of foetuses with signs of delayed ossificationα in: |
||||
Skull bones |
4.4 |
0.9 |
3.4 |
9.6* |
Caudal vertebrae |
7 |
2.8 |
6 |
37.8* |
Forelimbs/metacarpus |
2.6 |
0 |
0.9 |
9.1* |
Hind limbs/metatarsus |
5.3 |
2.8 |
3.4 |
29.2* |
α Signs of delayed ossification: not ossified (whole bone is not stained), poorly ossified (whole bone is poorly stained), and irregular spongy bones.
* P < 0.05; chi-square test
Applicant's summary and conclusion
- Conclusions:
- The no-observed-adverse-effect level (NOAEL) for maternal toxicity and for embryo-foetotoxicity of β-myrcene administered orally (gavage) was considered to be 500 mg/kg bw/day in Wistar rats.
- Executive summary:
A study was conducted to evaluate the embryo-foetotoxic potential of β-myrcene in the Wistar rats similarly to OECD Guideline 414.
β -Myrcene (250, 500 and 1200 mg/kg bw/day) in corn oil was given orally to Wistar rats from Day 6 to 15 of pregnancy. Two control groups, one received vehicle only and another without treatment, were also studied simultaneously. All rats were weighed on Day 0, 6, 16 and 20 of pregnancy. Caesarean sections were performed on Day 20 of pregnancy, and the number of resorptions and implantation sites were recorded. Foetuses were weighed and examined for external, visceral and skeletal malformations.
No adverse effects on the offspring were seen with the lowest dose tested, but at 500 mg/kg bw/day and higher doses, decreased birth weight, increased perinatal mortality and delayed day of appearance of landmarks of postnatal development were observed. Moreover, fertility was impaired in female offspring exposed to the two highest doses of β-myrcene. However it is difficult to know if this effect was related to reprotoxicity or due to the general toxicity observed at these dose-levels .
In conclusion, the no-observed-adverse-effect level (NOAEL) for maternal toxicity and for embryo-foetotoxicity of β -myrcene administered orally (gavage) was considered to be 500 mg/kg bw/day in Wistar rats.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.