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EC number: 294-351-9 | CAS number: 91697-89-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Abies sibirica, Pinaceae.
- 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
- Skin irritation/corrosion: irritating, based on available data and additivity principles.
- Eye irritation: irritating, based on additivity principles.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Irritation parameter:
- other: classification
- Remarks on result:
- other: skin irritant category 2
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Executive summary:
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 (2017) 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
CAS
Classification according to the Regulation (EC) No. 1272/2008 (CLP)
Skin irritation
Source
Pinene alpha
80-56-8
SCI2, H315
ECHA C&L inventory - self classification
Pinene Beta
127-91-3
SCI2, H315
ECHA C&L inventory - self classification
Delta 3 carene
13466-78-9
SCI2, H315
ECHA C&L inventory - self classification
Myrcene beta
123-35-3
SCI2, H315
ECHA C&L inventory - self classification
Limonene
138-86-3
SCI2, H315
ECHA C&L inventory - Harmonized Classification
Source: ECHA disseminated dossiers or self classification
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on rabbits at one high dose.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw - Duration of treatment / exposure:
- Single treatment (24 h exposure)
- Observation period:
- 14 days
- Number of animals:
- Total: 10 animals
- Details on study design:
- no details
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- - Slight and moderate redness was observed in 6/10 and 4/10 animals, respectively.
- Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively. - Other effects:
- - No mortality was observed.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the test conditions, Abies Sibirica Oil induced slight to moderate skin irritation in rabbits.
- Executive summary:
In an acute dermal toxicity study, ten rabbits were topically applied with a single dose of Abies Sibirica Oil at 5000 mg/kg bw. All animals were observed for mortality, clinical signs and local reactions.
No mortality occurred at the tested dose level. Slight and moderate redness was observed in 6/10 and 4/10 animals, respectively. Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively.
Under the test conditions, Abies Sibirica Oil induced slight to moderate skin irritation in rabbits.
This study was conducted according to a non-standard method and adequate scoring of skin effects was not provided, therefore it was not possible to take a decision of classification based solely on this study.
Referenceopen allclose all
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Irritation parameter:
- other: Classification
- Remarks on result:
- other: Eye damage category 2
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Executive summary:
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 (2017) was used to determine the serious eye damage/ eye irritant hazard of the registered substance. The decision of classification as irritant to the eyes was based on existing data on constituents (additivity principles):the registered substance has more than 10% of its constituents classified as Eye 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.
Constituants
Cas Number
Classification (CLP 1272/2008)
Source
Camphene
79-92-5
Cat.2, H319
ECHA C&L inventory - self classification
Myrcene beta
123-35-3
Cat.2, H319
ECHA C&L inventory - self classification
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The decision logic for classification of mixtures from the ECHA Guidance R.7a (2017) was used to determine the skin irritation/corrosion and eye irritation hazards of Pine needle (Abies Sibirica) oil.
Skin irritation/corrosion:
The decision of classification was based on the following arguments:
1/ Existing animal data: Skin irritation was observed in rabbits in an acute dermal toxicity study (Moreno, 1976) at the dose of 5000 mg/kg bw. Dermal reactions noted were slight and moderate redness in 6/10 and 4/10 animals, respectively. Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively.
Adequate scoring of skin effects was not provided, therefore it was not possible to take a decision of classification based solely on this study. However, based on these data, the test substance is considered as not corrosive to skin.
2/ Existing data on constituents (additivity principles):
- all Pine needle oils having equal or more than 10% of their constituents classified as Skin irritant Category 2 should be classified as skin irritant without further testing according to the Regulation (EC) No 1272/2008.
Eye irritation:
Pine needle oil has not been tested itself, but there are sufficient data on its individual ingredients to adequately characterize the hazard of the mixture. Additivity principles were therefore applied:
- all Pine needle oils having equal or more than 10% of their constituents classified as Eye irritant Category 2 should be classified as eye irritant without further testing according to the Regulation (EC) No 1272/2008.
Constituent |
CAS |
Classification according to the Regulation (EC) No. 1272/2008 (CLP) |
Source |
||
Skin irritation |
Eye irritation |
||||
Pinene alpha |
80-56-8 |
SCI2, H315 |
- |
ECHA C&L inventory - self classification |
|
Pinene Beta |
127-91-3 |
SCI2, H315 |
- |
ECHA C&L inventory - self classification |
|
Delta 3 carene |
13466-78-9 |
SCI2, H315 |
- |
ECHA C&L inventory - self classification |
|
Myrcene beta |
123-35-3 |
SCI2, H315 |
EDI2, H319 |
ECHA C&L inventory - self classification |
|
Camphene |
79-92-5 |
- |
EDI2, H319 |
ECHA C&L inventory - self classification |
|
Limonene |
138-86-3 |
SCI2, H315 |
- |
ECHA C&L inventory - Harmonized Classification |
Justification for classification or non-classification
Harmonized classification:
Pine needle oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the typical composition provided by the Lead Registrant, Pine needle oil 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) and to the GHS.
Based on the typical composition provided by the Lead Registrant, Pine needle oil is also classified as eye irritant:
- Irritating to eyes Category 2 (H319: Causes serious eye irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
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.
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