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Diss Factsheets
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EC number: 939-409-2 | CAS number: 1329-99-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Based on a read across evaluation, the registered substance has a comparable physicochemical and toxicological profile to d-limonene. The study was conducted according to valid methods, however standards were slightly different at time of testing and limited data were available. In combination with the other weight of evidence, the data are considered relevant, reliable and adequate for classification.
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- The FEMA GRAS assessment of aliphatic and aromatic terpene hydrocarbons used as flavor ingredients
- Author:
- Adams T.B., Lucas C., McGowen M.M. , Waddell W.J. , Cohen S.M., Feron V.J. , Marnett L.J., Munro I.C.,Portoghese P.S. , . Rietjens I.M.C.M, Smith R.L.
- Year:
- 2 011
- Bibliographic source:
- Food and Chemical Toxicology 49 (2011) 2471-2494
- Reference Type:
- publication
- Title:
- Studies on D-limonene as a gallstone solubilizer (V) effects on development of rat fetuses and offsprings
- Author:
- Tsuji, M., Fujiski, Y., Okubo, A., Arikawa, Y., Noda, K., Ide, H., Ikeda, T.
- Year:
- 1 975
- Bibliographic source:
- Oyo Yakuri 10, 179–186
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Groups of pregnant Wistar rats (20/dose: 15 for teratogenicity study, 5 for postnatal development)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- d-limonene
- IUPAC Name:
- d-limonene
- Reference substance name:
- (R)-p-mentha-1,8-diene
- EC Number:
- 227-813-5
- EC Name:
- (R)-p-mentha-1,8-diene
- Cas Number:
- 5989-27-5
- IUPAC Name:
- 4-isopropenyl-1-methylcyclohexene
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): d-limonene
- Molecular formula (if other than submission substance): C10-H16
- Molecular weight (if other than submission substance): 136.24 g/mol
- Smiles notation (if other than submission substance): C([C@@H]1CCC(C)=CC1)(C)=C
- InChl (if other than submission substance): InChI=1S/C10H16/c1-8(2)10-6-4-9(3)5-7-10/h4,10H,1,5-7H2,2-3H3/t10-/m0/s1
- Structural formula attached as image file (if other than submission substance): See illustration attached
- Substance type: Organic monoconstituent
- Physical state: Clear, colorless liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Pregnant Wistar rats
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 1% gum-arabic solution
- Details on exposure:
- Volume administered: 5 mL/kg bw for all doses
- Duration of treatment / exposure:
- Days 9-15 of gestation.
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 591, or 2869 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- 20
- Control animals:
- yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Maternal toxicity was noted in the high-dose (40% mortality and decreased body weight on gestation day 16 compared to controls); however, by gestation day 20, body weights of high-dose dams were not significantly different from controls. No effects were seen in the low-dose group (591 mg/kg bw/day).
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 591 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The offspring of dams in the high-dose group showed several signs of toxicity including significant decreases in body weight in males, absolute and relative weights of the thymus and spleen in males and females, and absolute and relative ovary weights in females. High-dose offspring also exhibited delayed ossification of the metacarpal bone and proximal phalanx. However, any retarded ossification returned to normal within several weeks of birth. In the offspring of low-dose dams, males were reported to have significantly increased relative testes weights, while females exhibited significantly decreased absolute kidney weights compared to controls.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 591 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
In a prenatal developmental toxicity study, three groups of 20 female Wistar rats were orally administered 0, 591 and 2869 mg/kg bw/day of d-limonene on days 9–15 of gestation. Caesarean sections were performed on 15/20 rats and the number of dead, live or resorbed fetuses, sex ratio and number of implantation sites were recorded. Fetuses were weighed and examined for external, visceral and skeletal malformations. On the other 5/20, the number of live offsprings, gross differentiation and organ weights of offsprings were recorded until postnatal week 7.Maternal toxicity was noted in the high dose group, including increased mortality (40%) and decreased body weight on gestation day 16 compared to controls; however, by gestation day 20, body weights of high dose dams were not significantly different from controls. No effects were seen in the low-dose group (591 mg/kg bw/day). The offspring of dams in the high-dose group showed several signs of toxicity including significant decreases in body weight in males, absolute and relative weights of the thymus and spleen in males and females, and absolute and relative ovary weights in females. High-dose offspring also exhibited delayed ossification of the metacarpal bone and proximal phalanx. However, any retarded ossification returned to normal within several weeks of birth. In the offspring of low-dose dams, males were reported to have significantly increased relative testes weights, while females exhibited significantly decreased absolute kidney weights compared to controls.
Under the test conditions, the NOAEL for maternal toxicity was considered to be 591 mg/kg bw/day based on the deaths and decreased bodyweight gain. The NOAEL for fetal toxicity was considered to be 591 mg/kg bw/day based on the delayed skeletal formation and decreased bodyweight gain.
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.
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