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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 sensitisation: skin sensitizer,
based on available animal data and the presence of classified
ingredients.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 15 October - 17 December 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study, meets generally accepted scientific principles, but test conditions and results not sufficiently detailed.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Colworth guinea pig intradermal injection test: Guinea pigs were treated to induce sensitization by intradermal injections and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization at first challenge the induction and challenge sequences were repeated. Confirmatory further challenges were also done.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no details
- Route:
- intradermal
- Vehicle:
- other: intradermal injection - Dobs/saline; topical application - absolute alcohol
- Concentration / amount:
- Induction phase (intradermal injection): 1.875 %
Challenge phase:
- Intradermal injection: 0.75 % (up to 4th challenge)
- Topical application: 60 % (up to 4th challenge)
- Further challenges: 40 and 60 % topical application - Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal injection - Dobs/saline; topical application - absolute alcohol
- Concentration / amount:
- Induction phase (intradermal injection): 1.875 %
Challenge phase:
- Intradermal injection: 0.75 % (up to 4th challenge)
- Topical application: 60 % (up to 4th challenge)
- Further challenges: 40 and 60 % topical application - No. of animals per dose:
- Main test: 4 males for control and 10 animals (2 males and 8 females) for test item
- Reading:
- other: challenge 1, 3 and 4
- Group:
- test chemical
- Dose level:
- 0.75 % intradermal injection
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 1, 3 and 4. Group: test group. Dose level: 0.75 % intradermal injection. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 1 after the first induction injection
- Group:
- test chemical
- Dose level:
- 60 % topical application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 1 after the first induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 3 after the second induction injection
- Group:
- test chemical
- Dose level:
- 60 % topical application
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 3 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 3
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 3. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: challenge 4 after the second induction injection
- Group:
- test chemical
- Dose level:
- 60 % topical application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 4 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 4
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 4. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: challenge 5 after the second induction injection
- Group:
- test chemical
- Dose level:
- 40 % topical application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 5 after the second induction injection. Group: test group. Dose level: 40 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 5 after the second induction injection
- Group:
- test chemical
- Dose level:
- 60 % topical application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 5 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 5
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 5. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: challenge 6 after the second induction injection
- Group:
- test chemical
- Dose level:
- 40 % topical application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 6 after the second induction injection. Group: test group. Dose level: 40 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 6 after the second induction injection
- Group:
- test chemical
- Dose level:
- 60 % topical application
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 6 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 6
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 6. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: challenge 7 after the second induction injection
- Group:
- test chemical
- Dose level:
- 40 % topical application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 7 after the second induction injection. Group: test group. Dose level: 40 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 7 after the second induction injection
- Group:
- test chemical
- Dose level:
- 60 % topical application
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 7 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 7
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 7. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the test conditions, Pine Needle Siberica induced weak sensitisation in guinea pigs.
- Executive summary:
In a skin sensitisation test, ten guinea pigs (males and females) were treated with test item, Pine Needle Siberica by intradermal injections (1.875 %) and were challenged approximately 2 weeks later by intradermal injection (0.75 %) and topical application (60 %). As there was no evidence of sensitization at first challenge the induction and challenge sequences were repeated. Confirmatory further challenges were also done (40 and 60 % topical application). The test concentrations for the main study were determined from a preliminary study at the concentrations ranging from 0.05 % to 1 % (intradermal injection) and 15 to 100 % (topical application).
During challenge phase, 1/10 positive reactions at the 3rd challenge, 3/10 positive reactions at the 6th challenge, 2/10 positive reactions at the 7th challenge were observed. No reactions were observed in control group.
Under the test conditions, Pine Needle Siberica induced weak sensitisation in guinea pigs.
- Endpoint:
- skin sensitisation, 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
- Key result
- Parameter:
- other: Classification
- Remarks on result:
- other: Skin sensitiser category 1
- Interpretation of results:
- Category 1 (skin sensitising) 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 sensitising potential of the registered substance.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests but some of its constituents are classified as skin sensitisers Cat.1 (pinene alpha, pinene beta, limonene, delta 3 carene and terpinolene)
and are all potentially present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.
Referenceopen allclose all
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
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 sensitising potential of Pine needle oil.
Some ingredients of Pine needle oil have been classified as skin sensitizers Cat.1 (pinene alpha and beta, limonene, delta 3 carene, Terpinolene) and are all present above the generic concentration limit of 1%. Therefore Pine needle oil shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 1272/2008 .
This conclusion is supported by a guinea pig maximisation test (Storch, 1975) in which positive reactions were observed after a minimum of 3 challenges. 3/10 animals were positive for skin sensitisation at the 6th challenge.
Source: ECHA disseminated dossiers
- Pinene alpha:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html
- Pinene beta:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d85bc06-0d47-6e67-e044-00144f67d249/DISS-9d85bc06-0d47-6e67-e044-00144f67d249_DISS-9d85bc06-0d47-6e67-e044-00144f67d249.html
- Limonene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html
- Delta-3 -carene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ead810f-31dc-543d-e044-00144f67d031/DISS-9ead810f-31dc-543d-e044-00144f67d031_DISS-9ead810f-31dc-543d-e044-00144f67d031.html
- Terpinolene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031/DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031_DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031.html
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 sensitizer:
- Skin Sens. 1, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
No information was available regarding respiratory sensitisation.
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.