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Diss Factsheets
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EC number: 945-878-4 | CAS number: 93165-40-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
- Skin irritation/corrosion: irritating, based on the rules of the CLP Regulation for classification of mixtures
- Eye irritation: not irritating (read-across, OECD TG 437, GLP, Rel.1)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted and well described study in accordance with GLP and OECD Guideline 437 without any deviation.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on 10 July 2012/ signed on 30 November 2012)
- Species:
- other: bovine eye
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Eyes from adult cattle were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised and placed in Hanks' Balanced Salt Solution (HBSS), supplemented with Penicillin/Streptomycin, and transported to the laboratory on ice packs. The corneas were prepared immediately on arrival. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL was applied on each cornea
- Concentration: Test material: undiluted; negative control: 0.9 % w/v sodium chloride solution; positive control: ethanol - Duration of treatment / exposure:
- The undiluted test item was applied for 10 minutes at 32 ± 1 °C followed by an incubation period of 120 ± 10 minutes at 32 ± 1 °C.
- Observation period (in vivo):
- - Corneal opacity was measured pre-treatment, post-treatment and post-incubation (after 120 ± 10 minutes of incubation).
- Application of Sodium Fluorescein (4 mg/mL) and corneal permeability was measured after 90 min of incubation at 32 ± 1 °C. - Number of animals or in vitro replicates:
- Total: 9 corneas - 3 corneas/group for test item, negative and positive controls
- Details on study design:
- Details of test procedure: Corneas obtained from freshly slaughtered adult cattle (from a local abattoir) were mounted in corneal holders. Both chambers of each BCOP holder were filled with complete MEM culture media (MEM) and incubated for 60 minutes at 32 ± 1 °C. Before the treatment, opacity measurement was performed using an opacitometer. The test item (0.75 mL) was applied on each cornea for 10 minutes at 32 ± 1 °C. At the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM. The anterior chamber was refilled with fresh complete MEM. A post-treatment opacity reading was taken and each cornea was visually observed. The holders were incubated, anterior chamber facing forward, at 32 ± 1 °C for 120 ± 10 minutes. After incubation the holders were removed from the incubator and a final opacity reading was taken. Each cornea was visually observed. Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (4 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1 °C for 90 minutes. After incubation the medium in the posterior chamber of each holder was decanted and retained. 360 µL of medium representing each cornea was applied to a designated well on a 96-well plate and the optical density at 492 nm (OD492) was measured.
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 2.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- IVIS = 0.3
- Positive controls validity:
- valid
- Remarks:
- IVIS = 50.5
- Irritant / corrosive response data:
- - In Vitro Irritancy Score (IVIS) were 2.8, 0.3 and 50.5 for test item, negative and positive controls, respectively.
- Other effects:
- - The corneas treated with the test item were clear post treatment and post incubation.
- The corneas treated with the negative control item were clear post treatment and post incubation.
- The corneas treated with the positive control item were cloudy post treatment and post incubation. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Pinus Pinaster Oil, induced an IVIS of 2.8 and is not classified as corrosive or severe irritant for the isolated bovine cornea. Furthermore as the IVIS score is lower than 3, it can be concluded that the test item is not an ocular irritant at all.
- Executive summary:
In an in vitro eye irritation study performed according to the OECD Guideline 437 and in compliance with GLP, 0.75 mL of Pinus Pinaster Oil was applied to isolated bovine corneas mounted in corneal holders, and incubated for 120 ± 10 minutes at 32 ± 1 °C using the closed chamber method. Three corneas were used for each treated series (undiluted test item; negative control; positive control: ethanol). Before the treatment, a first opacity measurement was performed using an opacitometer. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
The test item, negative and positive control induced an IVIS of 2.8, 0.3 and 50.5, respectively. The corneas treated with the negative control and test item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation. The positive control In Vitro Irritancy Score was within the range of 30.9 to 67.7, therefore the acceptance criterion was satisfied.
Under the test conditions, Pinus Pinaster Oil, induced an IVIS of 2.8 and is not classified as corrosive or severe irritant for the isolated bovine cornea. Furthermore as the IVIS score is lower than 3, it can be concluded that the test item is not an ocular irritant and therefore Pinus pinaster oil is not classified for eye irritation according to the Regulation (EC) No. 1272/2008 and the Directive 67/548/EEC.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Further information is included as attachment to Section 13] - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- 2.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- IVIS = 0.3
- Positive controls validity:
- valid
- Remarks:
- IVIS = 50.5
- Irritant / corrosive response data:
- - In Vitro Irritancy Score (IVIS) were 2.8, 0.3 and 50.5 for test item, negative and vehicle controls, respectively.
- Other effects:
- - The corneas treated with the test item were clear post treatment and post incubation.
- The corneas treated with the negative control item were clear post treatment and post incubation.
- The corneas treated with the positive control item were cloudy post treatment and post incubation. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, Pinus Pinaster Oil, induced an IVIS of 2.8 and is not classified as corrosive or severe irritant for the isolated bovine cornea. Furthermore as the IVIS score is lower than 3, it can be concluded that the test item is not an ocular irritant at all. Therefore, the registered substance Galbanum oil is not an occular irritant.
- Executive summary:
In an in vitro eye irritation study performed according to the OECD Guideline 437 and in compliance with GLP, 0.75 mL of Pinus Pinaster Oil was applied to isolated bovine corneas mounted in corneal holders, and incubated for 120 ± 10 minutes at 32 ± 1 °C using the closed chamber method. Three corneas were used for each treated series (undiluted test item; negative control; positive control: ethanol). Before the treatment, a first opacity measurement was performed using an opacitometer. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
The test item, negative and positive control induced an IVIS of 2.8, 0.3 and 50.5, respectively. The corneas treated with the negative control and test item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation. The positive control In Vitro Irritancy Score was within the range of 30.9 to 67.7, therefore the acceptance criterion was satisfied.
Under the test conditions, Pinus Pinaster Oil, induced an IVIS of 2.8 and is not classified as corrosive or severe irritant for the isolated bovine cornea. Furthermore as the IVIS score is lower than 3, it can be concluded that the test item is not an ocular irritant and therefore the registered substance Galbanum oil is not classified for eye irritation according to the Regulation (EC) No. 1272/2008 and the Directive 67/548/EEC.
Referenceopen allclose all
See the attached document for information on tables of results
See the attached document for information on tables of results
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation.
The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) was used to determine the skin irritation/corrosion hazard of the registered substance. The decision of classification as skin irritant was based on existing data on constituents (additivity principles): the registered substance has more than 10% of its constituents classified as Skin irritant Category 2 and should be classified as a skin irritant without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008
Constituent |
Classification according to the Regulation (EC) No. 1272/2008 (CLP) |
Source |
|
Skin irritation |
Eye irritation |
||
alpha-pinene |
SCI 2 (H315) |
- |
Self-classification |
beta-pinene |
SCI 2 (H315) |
- |
Self-classification |
delta-3-carene | SCI 2 (H315) |
- | Self-classification |
Source: ECHA disseminated dossiers
Eye irritation:
In an in vitro eye irritation study performed according to the OECD Guideline 437 and in compliance with GLP, 0.75 mL of Pinus Pinaster Oil was applied to isolated bovine corneas mounted in corneal holders, and incubated for 120 ± 10 minutes at 32 ± 1 °C using the closed chamber method. Three corneas were used for each treated series (undiluted test item; negative control; positive control: ethanol). Before the treatment, a first opacity measurement was performed using an opacitometer. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
The test item, negative and positive control induced an IVIS of 2.8, 0.3 and 50.5, respectively. The corneas treated with the negative control and test item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation. The positive control In Vitro Irritancy Score was within the range of 30.9 to 67.7, therefore the acceptance criterion was satisfied.
Under the test conditions, Pinus Pinaster Oil, induced an IVIS of 2.8 and is not classified as corrosive or severe irritant for the isolated bovine cornea.Furthermore as the IVIS score is lower than 3, it can be concluded that the test item is not an ocular irritant and thereforethe registered substance Galbanum oil is not classified for eye irritation according to the Regulation (EC) No. 1272/2008 and the Directive 67/548/EEC.
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the available information and typical composition provided by the Lead Registrant, the registered substance is classified as skin irritant: Skin Irritant Category 2 (H315: Causes skin irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).
Based on the available data on Pinus pinaster oil, the registered substance Galbanum oil is not classified for eye irritation according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) .
No information was available regarding respiratory irritation.
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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