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EC number: 946-670-6 | 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 oral toxicity (OECDTG401): >5000 mg/kg bw (read-across from Cedarwood Virginia oil)
Acute dermal toxicity (OECDTG402): >5000 mg/kg bw (read-across from Cedarwood Virginia oil)
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:
- key study
- Justification for type of information:
- The full read across justification report is attached under "Attached justification".
20 December 2017 READ-ACROSS STUDY / CW TX TERPENES / ACUTE ORAL TOXICITY I&B9W8768R001F1.0
According to Annex VII, 8.5 of the REACh Regulation (EC) No 1907/2006, acute toxicity by the oral route is standard information required for the registration of substances manufactured or imported in quantities of one tonne per year or more. However, according to Annex XI, 1.5 of the REACH Regulation, Read-across and grouping approaches can be used to adapt the standard testing regime. This read-across study report follows notably the recommendations made by the European Chemicals Agency in its “Guidance on information requirements and chemical safety assessment Chapter R.6 – QSARs and grouping of chemicals” (ECHA, 2008) and in its document “Read-Across Assessment Framework (RAAF)” (ECHA, 2017).
A read-across approach appears appropriate to predict the endpoint “, Acute toxicity by the oral route” for the substance Cedarwood Texas oil distilled - Terpenes (Cedrene and Thujopsene) because:
An acute oral toxicity study, according to OECD test guideline 401, is available for the substance Cedarwood Virginia oil, (CW Virginia), which composition is very similar.
The concentrations of the main constituents cedrene α and β, for which a high toxic hazard is identified, but do not lead to acute oral toxicity classification, are similar in the source Cedarwood Virginia oil; and the concentration of a minor constituent, cuparene, which has been notified for acute hazard by a small number of notifiers in the C&L inventory, is also comparable in source and target UVCB substances.
This report follows the RAAF method and so presents:
1) The hypothesis: analogue read-across approach, based on the similarity of the structures and the absence of acute oral toxicity for these types of structures;
2) The scientific justifications (“Assessment Elements”) and their evaluation (“Assessment Options”); which demonstrate the confidence that can be put in this prediction.
3) The conclusions, usable for classification assessment or risk assessment, which are summarised hereafter. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- None
- Clinical signs:
- other: Slight lethargy
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: not classified
- Remarks:
- Based on CLP criteria
- Conclusions:
- The acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. Based on the available information, the Cedarwood Texas oil distilled - Terpenes does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. A single 5000 mg/kg bw dose of Cedarwood Virginia was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. Mortality was not noted. Slight lethargy was seen in animals dosed with the test material. The oral LD50 value of Cedarwood Virginia in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The full read across justification report is attached under "Attached justification".
According to Annex VII, 8.5 of the REACh Regulation (EC) No 1907/2006, acute toxicity by the oral route is standard information required for the registration of substances manufactured or imported in quantities of one tonne per year or more. However, according to Annex XI, 1.5 of the REACH Regulation, Read-across and grouping approaches can be used to adapt the standard testing regime. This read-across study report follows notably the recommendations made by the European Chemicals Agency in its “Guidance on information requirements and chemical safety assessment Chapter R.6 – QSARs and grouping of chemicals” (ECHA, 2008) and in its document “Read-Across Assessment Framework (RAAF)” (ECHA, 2017).
A read-across approach appears appropriate to predict the endpoint “, Acute toxicity by the oral route” for the substance Cedarwood Texas oil distilled - Terpenes (Cedrene and Thujopsene) because:
An acute oral toxicity study, according to OECD test guideline 401, is available for the substance Cedarwood Virginia oil, (CW Virginia), which composition is very similar.
The concentrations of the main constituents cedrene α and β, for which a high toxic hazard is identified, but do not lead to acute oral toxicity classification, are similar in the source Cedarwood Virginia oil; and the concentration of a minor constituent, cuparene, which has been notified for acute hazard by a small number of notifiers in the C&L inventory, is also comparable in source and target UVCB substances.
This report follows the RAAF method and so presents:
1) The hypothesis: analogue read-across approach, based on the similarity of the structures and the absence of acute oral toxicity for these types of structures;
2) The scientific justifications (“Assessment Elements”) and their evaluation (“Assessment Options”); which demonstrate the confidence that can be put in this prediction.
3) The conclusions, usable for classification assessment or risk assessment, which are summarised hereafter. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- None
- Clinical signs:
- other: Slight lethargy
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: not classified
- Remarks:
- Based on CLP criteria
- Conclusions:
- The acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. Based on the available information, the Cedarwood Texas oil distilled - Terpenes does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. A single 5000 mg/kg bw dose of Cedarwood Virginia was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. Mortality was not noted. Slight lethargy was seen in animals dosed with the test material. The oral LD50 value of Cedarwood Virginia in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- - Principle of test: A single 5000 mg/kg bw dose of Cedarwood Virginia oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days.
- GLP compliance:
- no
- Remarks:
- pre-glp
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- h No.of test material: Sample marking: 73-9 - Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: not specified
- Other examinations performed: general symptomatology - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- None
- Clinical signs:
- other: slight lethargy
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- The oral LD50 of Cedarwood Virginia oil was determined to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
A single 5000 mg/kg bw dose of Cedarwood Virginia oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. Mortality was not noted. Slight lethargy was seen in animals dosed with the test material. The oral LD50 value of Cedarwood Virginia in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The justification document for read-across is attached to the target record
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- - Principle of test: In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days.
- GLP compliance:
- no
- Remarks:
- pre GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- No.of test material: Sample marking: 73-9 - Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
- Concentration (if solution): undiluted - Duration of exposure:
- not specified
- Doses:
- Limit dose: 5000 mg/kg bw
- No. of animals per sex per dose:
- 9
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations : daily
- Necropsy of survivors performed: not specified
- Other examinations performed: Skin irritation, others not specified - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Slight redness - 7/9 Moderate redness - 1/9 Slight edema - 3/9 Moderate edema - 6/9
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- The dermal LD50 of Cedarwood Virginia were determined to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days. No mortality was observed, and the LD50 was established to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The full read across justification report is attached under "Attached justification".
10 April 2018 READ-ACROSS STUDY / CW TX OIL TERPENES (1 & 2) / ACUTE DERMAL TOXICITY I&B9W8768R001F1.0
According to Annex VIII, 8.5 of the REACh Regulation (EC) No 1907/2006, Acute toxicity by the Dermal route is standard information required for the registration of substances manufactured or imported in quantities of 10 tonnes per year or more. However, according to Annex XI, 1.5 of the REACH Regulation, Read-across and grouping approaches can be used to adapt the standard testing regime. This read-across study report follows notably the recommendations made by the European Chemicals Agency in its “Guidance on information requirements and chemical safety assessment Chapter R.6 – QSARs and grouping of chemicals” (ECHA, 2008) and in its document “Read-Across Assessment Framework (RAAF)” (ECHA, 2017).
A read-across approach appears appropriate to predict the endpoint “Acute dermal toxicity” for the substance Cedarwood Texas oil distilled - Terpenes (Cedrene and Thujopsene) because:
An acute dermal toxicity study, according to OECD test guideline 402, is available for the substance Cedarwood Virginia oil, (CW Virginia), which composition is very similar.
The concentrations of the main constituents cedrene α and β, for which a high toxic hazard is identified, but do not lead to acute dermal toxicity classification, are similar in the source Cedarwood Virginia oil; and the concentration of a minor constituent, cuparene, which has been notified for acute hazard by a small number of notifiers in the C&L inventory, is also comparable in source and target UVCB substances.
This report follows the RAAF method and so presents:
1) The hypothesis: analogue read-across approach, based on the similarity of the structures and the absence of Acute dermal toxicity for these types of structures;
2) The scientific justifications (“Assessment Elements”) and their evaluation (“Assessment Options”); which demonstrate the confidence that can be put in this prediction.
3) The conclusions, usable for classification assessment or risk assessment, which are summarised hereafter. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Slight redness - 7/9 Moderate redness - 1/9 Slight edema - 3/9 Moderate edema - 6/9
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- The acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. Based on the available information, the Cedarwood Texas oil distilled - Terpenes does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil.
In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days. No mortality was observed, and the LD50 was established to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The full read across justification report is attached under "Attached justification".
10 April 2018 READ-ACROSS STUDY / CW TX OIL TERPENES (1 & 2) / ACUTE DERMAL TOXICITY I&B9W8768R001F1.0
According to Annex VIII, 8.5 of the REACh Regulation (EC) No 1907/2006, Acute toxicity by the Dermal route is standard information required for the registration of substances manufactured or imported in quantities of 10 tonnes per year or more. However, according to Annex XI, 1.5 of the REACH Regulation, Read-across and grouping approaches can be used to adapt the standard testing regime. This read-across study report follows notably the recommendations made by the European Chemicals Agency in its “Guidance on information requirements and chemical safety assessment Chapter R.6 – QSARs and grouping of chemicals” (ECHA, 2008) and in its document “Read-Across Assessment Framework (RAAF)” (ECHA, 2017).
A read-across approach appears appropriate to predict the endpoint “Acute dermal toxicity” for the substance Cedarwood Texas oil distilled - Terpenes (Cedrene and Thujopsene) because:
An acute dermal toxicity study, according to OECD test guideline 402, is available for the substance Cedarwood Virginia oil, (CW Virginia), which composition is very similar.
The concentrations of the main constituents cedrene α and β, for which a high toxic hazard is identified, but do not lead to acute dermal toxicity classification, are similar in the source Cedarwood Virginia oil; and the concentration of a minor constituent, cuparene, which has been notified for acute hazard by a small number of notifiers in the C&L inventory, is also comparable in source and target UVCB substances.
This report follows the RAAF method and so presents:
1) The hypothesis: analogue read-across approach, based on the similarity of the structures and the absence of Acute dermal toxicity for these types of structures;
2) The scientific justifications (“Assessment Elements”) and their evaluation (“Assessment Options”); which demonstrate the confidence that can be put in this prediction.
3) The conclusions, usable for classification assessment or risk assessment, which are summarised hereafter. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Slight redness - 7/9 Moderate redness - 1/9 Slight edema - 3/9 Moderate edema - 6/9
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- The acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. Based on the available information, the Cedarwood Texas oil distilled - Terpenes does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil.
In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days. No mortality was observed, and the LD50 was established to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The justification document for read-across is attached to the target record
Additional information
The acute toxicity of Cedarwood Texas Terpenes was assessed by using read across from Cedarwood Virginia oil. The summary of the studie is presented below, and the read across justifications are attached to the acute toxicity target records.
Acute oral toxicity (OECDTG401, Cedarwood Virginia oil)
A single 5000 mg/kg bw dose of Cedarwood Virginia oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. Mortality was not noted. Slight lethargy was seen in animals dosed with the test material. The oral LD50 value of Cedarwood Virginia oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study.Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Acute dermal toxicity (OECDTG402, Cedarwood Virginia oil)
The acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil.
In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days. No mortality was observed, and the LD50 was established to be higher than 5000 mg/kg bw.Based on the available information, the test substance does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)
Justification for classification or non-classification
The acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil.
Based on the available read across data, the substance does not need to be classified for acute toxicity in accordance to EU CLP (1272/2008 and its amendments).
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.