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EC number: 283-626-9 | CAS number: 84696-07-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cupressus sempervirens, 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- 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 data
- Irritation parameter:
- other:
- Remarks on result:
- not determinable because of methodological limitations
- Irritant / corrosive response data:
- - Mortality was observed in 2/10 animals (first animal died on Day 4 and second animal died on Day 13).
- Slight and moderate redness were observed in 2/10 and 7/10 animals, respectively.
- Moderate oedema was observed in 9/10 animals. - Other effects:
- - No other clinical signs were observed
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the test conditions, Cypress oil induced slight to moderate skin irritation in rabbits.
- Executive summary:
In an acute dermal toxicity study (limit test), ten rabbits were given a single dermal application of Cypress oil at 5000 mg/kg bw. Animals were observed for mortality, clinical signs and local reactions for 14 days.
Mortality was observed in 2/10 animals. Slight and moderate redness were observed in 2/10 and 7/10 animals respectively. Moderate oedema was observed in 9/10 animals. No other clinical signs were observed.
Under the test conditions, Cypress 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 on the classification based solely on this study.
Acute dermal LD50 of test material was higher than 5000 mg/kg bw
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- - Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cypress, Cupressus sempervirens, ext.
- EC Number:
- 283-626-9
- EC Name:
- Cypress, Cupressus sempervirens, ext.
- Cas Number:
- 84696-07-1
- IUPAC Name:
- Essential oil of Cupressus Sempervirens (Cupressaceae) obtained from leaves, twigs and fruits by steam distillation
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Cypress oil
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- Total: 10 animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observation: Observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 1/10 animal was died on Day 1
- Mortality:
- 1/10 animal was died on Day 1.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No data
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, oral LD50 of Cypress oil is higher than 5000 mg/kg bw in rats, therefore it is not classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
- Executive summary:
In an acute oral toxicity study (limit test), ten rats were given a single oral dose of Cypress oil at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.
1/10 animal was died on Day 1. No clinical signs were observed. In this study, the oral LD50 of Cypress oil was higher than 5000 mg/kg bw in rats.
Under the test conditions, oral LD50 of Cypress oil is higher than 5000 mg/kg bw in rats, therefore it must not be classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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