Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 701-285-0 | CAS number: 554-61-0
- 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
Description of key information
DELTA-3-CARENE (source substance) and DELTA-2-CARENE (target substance) are two structurally related substances.
In GLP in vitro studies using Episkin model, DELTA-3-CARENE led to a cell viability of 29.8 ± 1.3 %.
Under the test conditions, DELTA-3-CARENE is classified as irritating to skin, R38, according to Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) N° 1272/2008.
DELTA-3-CARENE (source substance) and DELTA-2-CARENE (target substance) are two structurally related substances. Therefore, DELTA-2-CARENE is classified as irritating to skin, R38, according to Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) N° 1272/2008.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- DELTA-3-CARENE (source substance) and DELTA-2-CARENE (target substance) are two structurally related substances.
- Reason / purpose for cross-reference:
- read-across source
- Irritation / corrosion parameter:
- other: other: viability % (MTT assay)
- Value:
- 29.8
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 min. Reversibility: no data. Remarks: ± 1.3. (migrated information)
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, delta-3-carene is classified as irritating to skin, R38, according to Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) N° 1272/2008.
DELTA-3-CARENE (source substance) and DELTA-2-CARENE (target substance) are two structurally related substances. Therefore, DELTA-2-CARENE is classified as irritating to skin, R38, according to Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) N° 1272/2008. - Executive summary:
A GLP study conducted in vitro with human epidermis model EPISKIN was performed to assess the irritancy potential of delta-3-carene (method similar to ECVAM protocol version 1.8 of February 2009). 10 µL of the test item was applied directly on epidermis for 15 min on 3 epidermis. Positive control was 10 µL of 5% (w/v) SDS solution and negative control was 10 µL of PBS (each tested on 3 epidermis). MTT conversion assay was peformed to evaluate the percentage of cellular viability of the epidermis. Positive control had a percentage of cell viability of 18.7± 3.0 and test item 29.8 ± 1.3. As the percentage of cell viability is ≤ 50 %, the test item is considered to be irritating for skin.
Delta-3-carene is classified as irritating to skin, R38, according to Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) N° 1272 /2008.
Therefore, DELTA-2-CARENE is classified as irritating to skin, R38, according to Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) N° 1272/2008.
Reference
Negative control (PBS+): mean OD = 0.821
Positive control (5% SDS): % viability (MTT assay) = 18.7 ± 3.0
Test item: % viability (MTT assay) = 29.8 ± 1.3
Table 1: MTT conversion assay in living epidermis
|
|
O.D. 1 |
O.D. 2 |
Mean |
Standard deviation |
Viability % |
Mean Viability % |
Standard deviation |
Negative control |
Epidermis 1 |
0.768 |
0.808 |
0.788 |
0.028 |
96.0 |
100 |
0.044 |
Epidermis 2 |
0.855 |
0.864 |
0.860 |
0.006 |
104.7 |
|||
Epidermis 3 |
0.819 |
0.811 |
0.815 |
0.006 |
99.3 |
|||
Positive control |
Epidermis 1 |
0.124 |
0.145 |
0.135 |
0.015 |
16.4 |
18.7 |
0.030 |
Epidermis 2 |
0.158 |
0.131 |
0.145 |
0.019 |
17.6 |
|||
Epidermis 3 |
0.191 |
0.172 |
0.182 |
0.013 |
22.1 |
|||
Test item |
Epidermis 1 |
0.249 |
0.265 |
0.257 |
0.011 |
31.3 |
29.8 |
0.013 |
Epidermis 2 |
0.236 |
0.236 |
0.236 |
0.000 |
28.8 |
|||
Epidermis 3 |
0.230 |
0.254 |
0.242 |
0.017 |
29.5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
DELTA-3-CARENE (source substance) and DELTA-2-CARENE (target substance) are two structurally related substances.
In GLP in vitro studies using Episkin model, exposure of epidermis to delta-3-carene for 15 min lead to a cell viability, measured by MTT conversion, of 29.8 ± 1.3 %.
In a recent GLP in vivo eye irritation study on delta-3-carene performed according to OECD Guideline 405, instillation of delta-3-carene resulted in moderate redness of the conjunctivae associated with severe chemosis in all treated animals after 1 hour of instillation. The irritation completely resolved within 8 days. Mean individual scores at 24, 48 and 72 h after exposure for the 3 rabbits were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 2, 1.33, 1.33 for conjunctivae score and 2, 1.33, 1 for chemosis score.
Justification for selection of skin
irritation / corrosion endpoint:
Only one study available on the registered substance
Justification for selection of eye irritation endpoint:
Only one study available on the registered substance
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
As the percentage of cell viability obtained in Episkin model was ≤ 50 % for delta-3-carene, it is considered to be irritating to skin. Under the test conditions, delta-3-carene is classified as irritating to skin, R38, according to the criteria of Annex VI to the Directive 67/548/EEC and category 2 according to CLP Regulation (EC) N° 1272/2008.
delta-3 -Carene gave reversible irritating effects on rabbit eyes with irritation scores not high enough to lead to classification according to the criteria of Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008. Therefore, delta-3-carene is not classified for eye irritation according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.
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.