Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 207-856-6 | CAS number: 498-15-7
- 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
An OECD guideline 443 study in rats on the registered substance is planned according to the final decision of ECHA (Decision number: CCH-D-2114366659-31-01/F).
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
OECD 414 (gavage) in rats:
NOAEL for maternal toxicity = 175 mg/kg bw/day
An OECD guideline 414 study in rabbits on the registered substance is on-going according to the final decision of ECHA (Decision number: CCH-D-2114366659-31-01/F).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 175 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Study conducted according to the latest OECD guideline 414 and in compliance with GLP
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a prenatal developmental toxicity study performed according to OECD Guideline 414 and in compliance with GLP, three groups of 20 females received delta-3-carene at doses of 90, 175 or 350 mg/kg/day by oral gavage administration, from Day 6 to 19 after mating. A similarly constituted Control group received the vehicle, corn oil, at the same volume dose as the treated groups. Animals were killed on Day 20 after mating for reproductive assessment and fetal examination.
Clinical observations, body weight and food consumption were recorded. Adult females were examined macroscopically at necropsy on Day 20 after mating and the gravid uterus weight recorded. All fetuses were examined macroscopically at necropsy and subsequently by detailed internal visceral examination or skeletal examination.
The mean concentrations of delta-3-carene in test formulations analyzed for the study were within ±8% of nominal concentrations, confirming accurate formulation.
Transient chin rubbing was evident at 90, 175 or 350 mg/kg/day and was attributed to poor palatability ofdelta-3-carene.
A treatment related loss in body weight was evident after the first administration at 90, 175 or 350 mg/kg/day and subsequent body weight gain during Days 14-20 of gestation at 350 mg/kg/day and food intake at 175 or 350 mg/kg/day were low. Food intake was marginally low at 90 mg/kg/day during Days 6-10 of gestation.
Adjusted body weight change was low or markedly low at 175 or 350 mg/kg/day and gravid uterine weight was marginally low at 350 mg/kg/day.
Oral gavage administration of delta-3-carene resulted in small body weight loss following the first dose at 90, 175 or 350 mg/kg/day and subsequent low weight gain (-24%) and food intake at 350 mg/kg/day. Therefore, the No-Observed-Adverse-Effect-Level (NOAEL) for maternal toxicity was 175 mg/kg/day.
An OECD guideline 414 study in rabbits on the registered substance is on-going according to the final decision of ECHA (Decision number: CCH-D-2114366659-31-01/F).
Justification for classification or non-classification
An OECD guideline 443 study is planned to assess the potential effects of the registered substance on reproductive parameters.
Additional information
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.

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