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EC number: 273-309-3 | CAS number: 68956-56-9
- 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
In an in vivo skin irritation study on the substance and in an in vitro skin irritation study on alpha pinene, results of irritation led to classification as irritating to skin, except in the in vivo study when considering CLP criteria.
In an in vivo eye irritation study in camphene and an in vitro study on Terpinolene multiconstituent, results of irritation led to classification as irritating to eye, except in the in vivo study when considering Directive 67/548/EEC criteria.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation study performed similarly to OECD Guideline 404 and in compliance with GLP, three New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted test item, DERTOL 20 DD (Hydrocarbons, terpene processing by-products) under a semi-occlusive dressing for 4 h in normal and scarified skin. After removal of the dressings, irritation was scored as outlined in the OECD Guideline 404 at 1, 24, 48 and 72 h after exposure. Irritative phenomena were relatively important and slowly reversible. A slight oedema as well as slight erythema remained visible on the 6th day. Slight changes in skin structure were also observed. Mean scores over 24, 48 and 72 h for each animal were 2.0, 2.0 and 2.0 for erythema and 1.0, 1.0 and 1.7 for edema (normal skin) and 2.0, 2.0 and 2.0 for erythema and 1.0, 1.7 and 1.7 for edema (scarified skin). DERTOL 20 DD (Hydrocarbons, terpene processing by-products) is classified as "R38: irritating to skin" according to Directive 67/548/EEC and not classified as irritant according to CLP Regulation (EC) N° 1272/2008.
A GLP study conducted in vitro with human epidermis model EPISKIN was performed to assess the irritancy potential of alpha pinene (one of the main constituent of the substance) similarly to OECD guideline 439. 10 µL of 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 39.6 ± 5.6. As the percentage of viability is ≤ 50 %, the test item is considered to be irritating to skin. Under the test conditions, alpha pinene is classified as irritating to skin according to the Directive 67/548/EEC and to the CLP Regulation (EC) N° 1272/2008.
In an in vitro eye irritation study performed in compliance with GLP, 30 µL of the test item, Terpinolene multiconstituent (a structure-related substance) was applied to the human reconstructed corneal epithelium model (in duplicate) for 10 ± 2 min, 1 h ± 10 min and 3 h ± 30 min at room temperature. Contact timepoint for negative control (sodium chloride 0.9 % w/v) was 3 h ± 30 min and 10 ± 2 min and 1 h ± 10 min for positive control (SDS 1.5% w/w). At the end of each incubation period, each epithelium was rinsed, transferred to new well containing MTT solution and incubated for 1 h ± 10 min in CO2 incubator. Each epithelium was then transferred into a new well plate containing isopropanol (1 mL). After agitating for 1 h ± 10 min, the extract (200μL/well) was transferred into a 96 wells microplate and optical density was recorded at 570 nm with a plates reader. For each treated tissue the viability was expressed as mean percentage of cellular viability relative to the negative control and the exposure time that causes 50% of cell mortality (T50) was determined by linear regression analysis. T50 value for the test item was 42.88 min. Optical density value for the negative control was 1.152 and T50 value for positive control was 33.49 min and thus confirmed the validity of the test. Under the test conditions, the T50 value of the test item was between 10 and 60 min therefore it was considered as moderately irritant when applied on a human reconstructed corneal epithelium.
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, three rabbits of the New Zealand White strain were exposed to 100 mg of undiluted camphene (one of the main constituent of the substance) in one of the eyes while the other eye corresponded to the control. The eyes were examined for irritation scores at 1 hour and 1, 2, 3, and 7 days after application. Examination and scoring after instillation of fluoresceine was assessed at 24 h, 72 h and 7 days after test substance application. Application of camphene resulted in severe redness of the conjunctivae associated with slight to moderate chemosis in all treated animals. The irritation completely resolved within 7 days. Mean individual scores at 24, 48 and 72 hours after exposure for the 3 animals were 1.3, 0.7, 0.7 for cornea score; 0.7, 0.7, 0.3 for iris score; 2.3, 3, 2.3 for conjunctivae score and 2, 1.7, 0.7 for chemosis score. Under the test conditions, camphene is classified as ‘H319 Cause severe eye irritation (Category 2)’ according to CLP Regulation (EC) N° 1272/2008 but not classified according to Directive 67/548/EEC.Justification for selection of skin irritation / corrosion endpoint:
More than one study was available to assess the properties of the substance for this endpoint.
Justification for selection of eye irritation endpoint:
More than one study was available to assess the properties of the substance for this endpoint.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
In an in vivo skin irritation study on the substance and in an in vitro skin irritation study on one of its main constituent alpha pinene, results of irritation led to classification as irritating to skin, except in the in vivo study with CLP criteria. Therefore, in a conservative approach, the substance is classified as R38 Irritating to skin according to the Directive 67/548/EEC and as Category 2, H315 Causes skin irritation according to the CLP Regulation (EC) No. 1272/2008.
In an in vivo eye irritation study on camphene, one of the main constituent of the substance, and an in vitro study on a structure-related substance Terpinolene multiconstituent, results of irritation led to classification as irritating to eye, except in the in vivo study with Directive 67/548/EEC criteria. Therefore, in a conservative approach, the substance was classified as R36 Irritating to eyes according to the Directive 67/548/EEC and Category 2 H319 Causes serious eye irritation according to CLP Regulation (EC) No. 1272/2008.
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