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EC number: 943-438-6 | CAS number: 90063-59-5
- 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:
- weight of evidence
- Study period:
- 27-09-1988 to 4-10-1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study was conducted according to a method similar to OECD guideline 404 and under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Commission Directive 25 april 1984, Document L251, p106-108
- GLP compliance:
- yes
Test material
- Reference substance name:
- Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation
- EC Number:
- 943-438-6
- Cas Number:
- 90063-59-5
- IUPAC Name:
- Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation
- Test material form:
- liquid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Goreside Rabbits, Northchurch, Berkhamsted, Herfordshire
- Age at study initiation: 10-12 weeks
- Weight at study initiation: approximately 2 kg
- Housing:Individually housed in grid bottomed metal cages
- Diet (e.g. ad libitum): antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diets Services, Witham, Essex), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 57-69
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days (scoring at 1, 24, 48 and 72 hours and 7 days after dosing)
- Number of animals:
- 4 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: approximately 2.5 cm2 of the dorsal skin per patch
- Type of wrap if used: surgical lint, held in contact with the skin under a semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hrs
SCORING SYSTEM:
- Irritation was assessed and allocated a numerical value based on a grading scale (with scores 0-4).
- The system described in the Official Journal European Communities L257 (published 16th sept 1983) was used to classify the materials.
- The scoring system is in accordance with OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Irritant / corrosive response data:
- One hour after the dosing period well-defined erythema was observed in two animals and very slight to well-defined erythema was apparent in two animals. Slight to moderate edema was noted in two animals at 1 hour, one rabbit exhibited moderate edema and the remaining animals exhibited moderate to severe edema.
- Other effects:
- Desquamation from the surface of the treated skin was observed in three animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Remarks:
- in accordance with Annex I of 1272/2008/EC (CLP)
- Conclusions:
- It was concluded in the study that the substance needs to be classified according to the system described in the Official Journal of European Communities No. L257 (16 September 1983) and classification is also warranted according to the criteria outlined in Annex VI of 67/548/EEC (DSD). However, according to the current criteria for skin irritation/corrosion as outlined in Annex I of 1272/2008/EC (CLP) the substance does not need to be classified anymore for skin irritation/corrosion.
- Executive summary:
In an acute dermal irritation study (similar to OECD 404, testing material, Litsea Cubeba oil, was applied at a volume of 0.5 ml over an area of 2.5 cm2 on the dorsal skin, clipped free of fur, of four rabbits. The materials were held in contact with the skin under a semi-occlusive dressing for a four hour period after which the patches were removed. Skin reaction to the material was assessed after 1, 24, 48 and 72 hours and 7 days after the dosing period.
One hour after the dosing period well-defined erythema was observed in two animals and very slight to well-defined erythema was apparent in two animals. Slight to moderate edema was noted in two animals at 1 hour, one rabbit exhibited moderate edema and the remaining animals exhibited moderate to severe edema. In general this response slowly declined. Some differences in erythema and edema reaction between animals were observed. The average scores for erythema at 24, 48 and 72 hour after dosing were 2.0 in all four animals whereas the average scores for edema at 24, 48 and 72 hour after dosing were 1.2, 1.3, 2.3 and 2.5.
It was concluded in the study that the substance needs to be classified according to the system described in the Official Journal of European Communities No. L257 (16 September 1983) and classification is also warranted according to the criteria outlined in Annex VI of 67/548/EEC (DSD). However, according to the current criteria for skin irritation/corrosion as outlined in Annex I of 1272/2008/EC (CLP) the substance does not need to be classified anymore for skin irritation/corrosion.
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