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EC number: 946-570-2 | CAS number: -
- 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
Acute toxicity, oral in rats: LD50 > 2000 mg/kg bw (read-across substance: Cistus concrete; OECD 420, GLP, W, Rel. 1)
Acute toxicity, oral in rats: LD50 > 2000 mg/kg bw (read-across substance: Pinus pinaster oil; OECD 420, GLP, W, Rel. 1)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- The source substance represents a worse case towards acute oral toxicity for the target substance because it contains more constituents classified for acute oral toxicity than the registered substance.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Preliminary study:
- - No mortality and systemic toxicity were observed in the initial animal treated at 300 and 2000 mg/kg bw dose
- Animal showed expected gains in body weight over the observation period
- No abnormality was noted at necropsy - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- - No mortality was observed
- Clinical signs:
- - Hunched posture and increased salivation were observed in the additional four animals treated at 2000 mg/kg bw and one of these animals showed noisy respiration.
- Body weight:
- - All animals showed expected gains in body weight over the observation period
- Gross pathology:
- - No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the oral LD50 for Pinus Pinaster oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008. Therefore the registered substance is also not considered to require any classification for acute oral toxicity.
- Executive summary:
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, a group of five female Wistar (RccHan™:WIST) rats were given a single oral dose of the test item Pinus Pinaster oil at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. Before the main test, a sighting test was also conducted on 1 female rat/dose at 300 and 2000 mg/kg bw and animals were observed for 14 days. As no mortality occurred, the test item was administered to four additional animals at the dose level of 2000 mg/kg bw (main test).
No mortality was observed. No sign of systemic toxicity was observed in the initial animal treated at 300 and 2000 mg/kg bw dose level (sighting study). Signs of systemic toxicity observed in animals of the main study treated at a dose level of 2000 mg/kg bw were hunched posture, increased salivation and noisy respiration. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. In this study, the oral LD50 of Pinus Pinaster oil was considered to be higher than 2000 mg/kg bw in female rats.
Under the test conditions, the oral LD50 for Pinus Pinaster oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008. Therefore the registered substance is also not considered to require any classification for acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- The source substance and the target substance have the same botanical origin, Cistus ladaniferus (Cistaceae), and are extracts of the same parts of the plant.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Preliminary study:
- - No mortality or clinical signs were observed at 300 mg/kg bw.
- The animal showed expected gains in body weight over the observation period.
- No abnormalities were noted at necropsy. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at 2000 mg/kg bw.
- Clinical signs:
- No signs of systemic toxicity were noted during the observation period.
- Body weight:
- All animals showed expected gains in body weight over the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC. Therefore the registered substance is also not considered to require any classification for acute oral toxicity. - Executive summary:
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, groups (5 females/dose) of Wistar (RccHan™:WIST) rats were given a single oral (gavage) dose of test material at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Sighting study was conducted at the dose levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose for main study.
In the sighting study, no mortality or clinical signs were observed at 300 mg/kg bw. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. In the main study, no mortality or clinical signs were observed at 2000 mg/kg bw. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.
Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC. Therefore the registered substance is also not considered to require any classification of acute oral toxicity.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Referenceopen allclose all
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Recent GLP studies compliant with OECD guidelines
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: via oral route
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, groups (5 females/dose) of Wistar (RccHan™:WIST) rats were given a single oral (gavage) dose of test material at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Sighting study was conducted at the dose levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose for main study.
In the sighting study, no mortality or clinical signs were observed at 300 mg/kg bw. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. In the main study, no mortality or clinical signs were observed at 2000 mg/kg bw. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.
Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.Therefore the registered substance is also not considered to require any classification of acute oral toxicity.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, a group of five female Wistar (RccHan™:WIST) rats were given a single oral dose of the test item Pinus Pinaster oil at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. Before the main test, a sighting test was also conducted on 1 female rat/dose at 300 and 2000 mg/kg bw and animals were observed for 14 days. As no mortality occurred, the test item was administered to four additional animals at the dose level of 2000 mg/kg bw (main test).
No mortality was observed. No sign of systemic toxicity was observed in the initial animal treated at 300 and 2000 mg/kg bw dose level (sighting study). Signs of systemic toxicity observed in animals of the main study treated at a dose level of 2000 mg/kg bw were hunched posture, increased salivation and noisy respiration. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. In this study, the oral LD50 of Pinus Pinaster oil was considered to be higher than 2000 mg/kg bw in female rats.
Under the test conditions, the oral LD50 for Pinus Pinaster oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008.
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:
Acute toxicity via Oral route:
Based on the available information, the registered substance is:
- not classified according to the Regulation (EC) No. 1272/2008 and GHS.
Acute toxicity via Dermal route:This information is not available
Acute toxicity via Inhalation:This information is not available.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.
Specific target organ toxicity: single exposure (Dermal): This information is not available
Specific target organ toxicity: single exposure (Inhalation): This information is not available.
Based on its composition, the registered substance is not classified for aspiration hazard acording to CLP Regulation and GHS.
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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