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EC number: 285-360-9 | CAS number: 85085-29-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cupressus funebris, Cupressaceae.
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no 14 day observation period followed and hence, no reversibility of the effect was assessed; this deviation is not considered to compromise the result, the study is considered acceptable. Animals were immobilized in a canvas body sleeve during treatment
- Principles of method if other than guideline:
- no 14 day observation period followed and hence, no reversibility of the effect was assessed; this deviation is not considered to compromise the result, the study is considered acceptable. Animals were immobilized in a canvas body sleeve during treatment
- GLP compliance:
- no
- Remarks:
- Study performed prior to GLP adoption
Test material
- Reference substance name:
- Cypress, Cupressus funebris, ext.
- EC Number:
- 285-360-9
- EC Name:
- Cypress, Cupressus funebris, ext.
- Cas Number:
- 85085-29-6
- Molecular formula:
- Not applicable due to UVCB nature of the substance
- IUPAC Name:
- Essential oil of Cedarwood obtained from the wood of Cupressus funebris (Cupressaceae) by steam distillation
- Test material form:
- not specified
- Details on test material:
- For specific details on test material if available - See in RSS
- Name of test material (as cited in study report): Cedarwood oil Chinese
- Lot/batch No.: No data
- Purity: No data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9-12 w
Animals in telogen phase of hair growth are selected.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 4, 24, 48 and 72 h
- Number of animals:
- 8
- Details on study design:
- POSITIVE CONTROLS: yes, animals treated with diethyl phthalate (100%), cyclamen aldehyde (100%), geraniol (100%) (standards for comparison)
TEST SITE
Occlusive patches prepared by heat-sealing 1x1 24 ply gauze pads on to 1 (1/4) X 1 (1/4) squares of polythene sheeting . attached to 3 X (1/2) X 1 strips.
Animals are immobilized in a canvas body sleeve during treatment. The test susbstance was applied on the dorsal skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, wiped clean
- Time after start of exposure: 4 h
The application site is examined immediately (4h) and at 24, 48 and 72 h after treatment.
SCORING SYSTEM: 8 point anchored ordinate scale ranging from 'a' (very slight) to 'h' (severe). Wilcoxon Matched-Pairs Signed Ranks Test. See sextion 'any other information on materials and methods incl. tables' for details.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.67
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.33
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal: 7
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal: 8
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.67
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.67
- Irritation parameter:
- edema score
- Basis:
- animal: 7
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal: 8
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.67
- Irritant / corrosive response data:
- The test substance produced moderate to severe erythema and moderate edema. Fairly well developed suspected necrosis was seen in 3 animals at 24 h, still visible 72 h post-treatment. The observed necrosis warrants a classification for corrosion, it was observed at 24 h post treatment. Therefore, the test substance is considered to be corrosive to the skin and can be subclassified as Cat. 1C/H314, according to the classification criteria of Annex I of 1272/2008/EC (CLP). Necrosis was not detected in animals treated with the positive controls cyclame aldehyde and geraniol, and erythema/edema were more pronounced in test substance treated animals.
Any other information on results incl. tables
Table 1. Converted irritation scorings
erythema |
||||
Animal # |
24 hours |
48 hours |
72 hours |
AVG |
1 |
3 |
3 |
3 |
3.00 |
2 |
3 |
2 |
3 |
2.67 |
3 |
3 |
3 |
3 |
3.00 |
4 |
3 |
3 |
3 |
3.00 |
5 |
3 |
2 |
2 |
2.33 |
6 |
3 |
3 |
3 |
3.00 |
7 |
3 |
3 |
3 |
3.00 |
8 |
3 |
2 |
3 |
2.67 |
oedema |
||||
Animal # |
24 hours |
48 hours |
72 hours |
AVG |
1 |
3 |
3 |
3 |
3.00 |
2 |
3 |
3 |
3 |
3.00 |
3 |
3 |
3 |
3 |
3.00 |
4 |
3 |
3 |
3 |
3.00 |
5 |
3 |
3 |
3 |
3.00 |
6 |
3 |
2 |
3 |
2.67 |
7 |
3 |
3 |
3 |
3.00 |
8 |
3 |
2 |
3 |
2.67 |
Applicant's summary and conclusion
- Interpretation of results:
- other: skin corrosive
- Remarks:
- Based on CLP criteria
- Conclusions:
- Under the conditions of this study, the mean scores observed in the animals would lead to a classification for skin irritation. However, necrosis was observed in 3 animals, 24 hours after the 4 hour exposure period. Therefore, Cedarwood Chinese oil is considered corrosive to the skin of New Zealand rabbit, and shall be classified for skin corrosion (Skin Corr. 1C / H314) according to the criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
In this acute dermal irritation study (similar to OECD 404) the test substance Cedarwood Chinese was applied at a volume of 0.5 ml on the dorsal skin, clipped free of fur, of New Zeland White rabbits. The materials were held in contact with the skin under a semi-occlusive dressing for a 4 h period after which the patches were removed. Skin reaction to the material was assessed immediately, at 24, 48 and 72 h after dosing. Diethyl phthalate, cyclamen aldehyde, and geraniol were used as standards for comparison.
At 24 h after dosing, well-defined erythema and oedema were observed in most animals, that persisted at 72 h post-treatment and very slight to well-defined erythema was apparent in two animals. The mean scores for erythema (24, 48, 72 h) were in the range of 2.3 to 3.0, and for edema in the range of 2.67 to 3.0. Fairly well developed suspected necrosis was seen in 3 animals at 24 h, still visible 72 h post-treatment. Necrosis was not detected in animals treated with the positive controls cyclame aldehyde and geraniol, and erythema/edema was more pronounced in test substance treated animals.
It was concluded that under the conditions of this test, the substance needs to be classified as corrosive to the skin (Skin Corr. 1C / H314) according to the criteria laid down in Annex I of 1272/2008/EC (CLP).
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