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EC number: 204-622-5 | CAS number: 123-35-3
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1993
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study protocol is different from the standard OECD guidelines with ; absence of individual and historical control data, making the interpretation of results difficult.
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:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
- Principles of method if other than guideline:
- Method: β-Myrcene (0, 250, 500, 1000 or 1500 mg/kg bw/day) in corn oil was given orally to female Wistar rats from Day 15 of pregnancy to postnatal Day 21 and peri- and postnatal developmental toxicity effects were evaluated.
- GLP compliance:
- not specified
- Type of method:
- in vivo
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-methylideneocta-1,6-diene
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Day 15 of pregnancy to postnatal Day 21
- Frequency of treatment:
- Once daily
- Duration of test:
- Day 15 of pregnancy of F0 generation to postnatal Day 4 of F2 generation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
250, 500, 1000 or 1500 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 20, 12, 18, 14 and 15 pregnant females at concentrations of 0, 250, 500, 1000 and 1500 mg/kg bw/day, respectively
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- for peri- and postnatal developmental toxicity
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Decreased birth weight, increased perinatal mortality and delayed day of appearance of landmarks of postnatal development (at doses ≥ 500 mg/kg bw/day); impaired fertility in female offspring (at 1000 and 1500 mg/kg bw/day)
Observed effects
- Mortality: 5/15 rats died in 1500 mg/kg bw/day group; no mortality at other dose levels
- Body weight: Statistically significant decrease in body weight was observed at 1000 mg/kg bw/day (on gestation Day 20) and 1500 mg/kg bw/day (on gestation Day 20 and postnatal Day 1).
- Duration of pregnancy: Not affected at any dose levels; labour duration higher (> 6 hour) at 500 mg/kg bw/day (1 dam) and 1000 mg/kg bw/day (3 dams)
- Litter size: No treatment-related effects were observed but a higher proportion of stillbirths were detected in 1000 mg/kg bw/day group
- Newborn weight: Statistically significant lower newborn weight at doses ≥ 500 mg/kg bw/day (6.1 ± 0.35, 5.5 ± 0.74, 5.2 ± 0.94 and 4.9 ± 0.90 g at 0, 500, 1000 and 1500 mg/kg bw/day, respectively)
POSTNATAL EFFECTS
- Postnatal mortality: Statistically significant increase was observed at 500, 1000 and 1500 mg/kg bw/day during lactation period (1.8, 1.7, 14.4, 24.4 and 16.8% at 0, 250, 500, 1000 and 1500 mg/kg bw/day, respectively)
- Postnatal development: Day of first detection of primary coat was delayed with 500 mg/kg bw/day and higher doses, and the days of ear unfolding and eye opening were delayed with 1000 and 1500 mg/kg bw/day
- Fertility: Statistically significant effect was observed on the fertility of the offspring at 500, 1000 or 1500 mg/kg bw/day. Subsequent examination on male rats suggested that the reproductive failures were probably attributable to female infertility.
Any other information on results incl. tables
Table 1. Maternal weight changes (g)
Myrcene |
Days |
||
Day 0 of pregnancy |
Day 20 of pregnancy |
Postnatal Day 1 |
|
0 |
210.9 ± 13.5 |
314.4 ± 19.2 |
240.1 ± 15.7 |
250 |
208.8 ± 8.9 |
307.3 ± 22.6 |
239.1 ± 18.7 |
500 |
205.2 ± 13.4 |
306.1 ± 26.7 |
231.5 ± 23.1 |
1000 |
207.4 ± 18.8 |
293.0 ± 27.5* |
228.5 ± 22.4 |
1500 |
209.8 ± 12.3 |
288.4 ± 29.4* |
223.8 ± 17.9* |
Table 2: Physical signs of postnatal development of offspring
Myrcene |
Parameters |
||
Ear unfolding (%) |
Primary coat (%) |
Eye opening (%) |
|
0 |
98 |
90 |
39.4 |
250 |
97.5 |
100 |
47 |
500 |
95.8 |
62.4* |
38.7 |
1000 |
76.5* |
39.2* |
19.8* |
1500 |
88.5* |
61.2* |
20* |
Table 3: Outcome of fertility tests
Myrcene |
Outcome |
|
1st mating; no. mated/no. giving birth (%) |
1st + 2nd mating; no. mated/no. giving birth (%) |
|
0 |
54/50 (92.6) |
54/53 (98.2) |
250 |
31/31 (100) |
31/31 (100) |
500 |
43/34 (79.1)* |
43/42 (97.7) |
1000 |
24/16 (66.7)* |
24/19 (79.2)* |
1500 |
26/19 (73.1)* |
26/20 (76.9)* |
*significantly different (P < 0.05) from controls.
Applicant's summary and conclusion
- Conclusions:
- The no-observed-adverse-effect level (NOAEL) for peri- and postnatal developmental toxicity of β-myrcene administered orally (gavage) was considered to be 250 mg/kg bw/day in Wistar rats.
- Executive summary:
A study was conducted to evaluate the peri- and postnatal developmental toxicity of β-myrcene in the Wistar rats.
β -Myrcene (0, 250, 500, 1000 and 1500 mg/kg bw/day) in corn oil was given orally to female Wistar rats from Day 15 of pregnancy to postnatal Day 21. The progeny was examined at birth and subsequently to weaning. Mortality, weight gain and physical signs of postnatal development (ear unfolding, incisor eruption, fur development and eye opening) were evaluated. When the exposed offspring reached maturity (120 days) their reproductive capacity was assessed.
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.
Therefore, the no-observed-adverse-effect level (NOAEL) for peri- and postnatal developmental toxicity of β-myrcene administered orally (gavage) was considered to be 250 mg/kg bw/day in Wistar rats.
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