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EC number: 947-049-2 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD guideline 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- 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".
05 February 2018 READ-ACROSS STUDY / YLANG YLANG III OIL - ACUTE ORAL TOXICITY I&B9W8768R001F0.2
1 Executive Summary
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 Ylang Ylang III oil because:
The source substance used in this read-across, Ylang Ylang Ext/ I/ II oil, gives rise to the highest concern regarding the acute toxicity endpoint, as the constituents with known acute oral toxicological potential (4-Methylanisole, Linalool, Benzyl acetate) add up to 1 – 44 % (w/w) in the source versus 0.3 - 7.4 % (w/w) in the target UVCB.
An acute oral toxicity study, according to OECD test guideline 401, is available for the substance Ylang Ylang Ext, which has a composition very similar to the target substance.
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 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
- Preliminary study:
- Not relevant
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Coma and chromodacryorrhea were seen 24 hours post-treatment. These effects had disappeared 48 hours after treatment.
- Gross pathology:
- No effects were observed at necropsy
- Interpretation of results:
- other: Not classified
- Remarks:
- based on CLP criteria (Annex I of 1272/2008/EC)
- Conclusions:
- The oral LD50 value of Ylang Oil Extra in rats was established to be higher than 5000 mg/kg bw and was used for read-across to Ylang Ylang III oil. Based on this information, this substance does not need to be classified according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
A single 5000 mg/kg bw dose of Ylang Oil Extra was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No mortality was noted. Coma and chromodacryorrhea were observed 24 h post-treatment, effects that could no longer be detected 48 h after treatment. The oral LD50 value of Ylang Oil Extra in rats was established to be higher than 5000 mg/kg bw and was used for read-across to Ylang Ylang III oil. Based on this information, this substance does not need to be classified according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ylang-ylang, ext.
- EC Number:
- 281-092-1
- EC Name:
- Ylang-ylang, ext.
- Cas Number:
- 83863-30-3
- IUPAC Name:
- Essential oil of Ylang Ylang Ext/I/II obtained from the flowers of Cananga odorata (Annonaceae) by steam distillation
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Ylang oil extra
- Purity: No data
- Lot/batch No.: confidential
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ylang oil extra
- Purity: No data
- Lot/batch No.: confidential
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approximately 200 g
- Fasting period before study: 16-18 hrs
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: symptomatology
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Coma and chromodacryorrhea were seen 24 hours post-treatment. These effects had disappeard 48 hours after treatment.
- Gross pathology:
- No effects were observed during necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- based on CLP criteria (Annex I of 1272/2008/EC)
- Conclusions:
- The oral LD50 value of Ylang Oil Extra in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
A single 5000 mg/kg bw dose of Ylang Oil Extra was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No mortality was noted. Coma and chromodacryorrhea were observed 24 hours post-treatment, effects that could no longer be detected 48 hours after treatment.The oral LD50 value for Ylang Oil Extra in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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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