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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 9 May 1977 - 31 May 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD guideline 405 and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no OECD scoring system was used
- GLP compliance:
- no
- Remarks:
- performed pre-GLP.
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 / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 weeks
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: 100% - Duration of treatment / exposure:
- Single dose / continuous exposure (no washing)
- Observation period (in vivo):
- Up to 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not performed
SCORING SYSTEM: Opacity, corneal swelling, chemosis, discharge, iritis, pannus and discomfort were checked in the treated animals on specific timepoints after instillation (up to recovery). No detailed information available. It is therefore not possible to derive scores from this study that can be directly related to the OECD scoring system. Expert judgment has to be used to evaluate the results with regard to the current classification criteria.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- affecting 25-75% of corneal surface
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- % swelling
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- > 10 - < 59
- Max. score:
- 100
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- slight to moderate
- Irritant / corrosive response data:
- Litsea cubeba caused slight to moderate corneal lesions in two animals affecting between 25-75% of the corneal surface. These lesions were associated with slight to moderate corneal swelling. Opacity effects were also noted in two animals, but maximum grade was not >1. All animals developed slight to moderate conjunctivitis. All animals recovered within 7 days.
Any other information on results incl. tables
All three animals showed some irritating effects in the first days after exposure. Betwee day 2 and 7 after exposure recovery was completed in all animals. Reporting of the results was not in line with the current classification criteria and therefore have to be extrapolated based on expert judgement.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- based on the criteria outlined in 1272/2008/EC (CLP)
- Conclusions:
- Under the conditions of this study, Litsea cubeba oil was found to induce slight to moderate conjunctivitis in all test animals, but recovery was completed within 7 days. These results were extrapolated to the current classification criteria based on expert judgement. It was concluded that the test substance does not need to be classified for eye irritation based on the criteria outlined in 1272/2008/EC (CLP).
- Executive summary:
An eye irritation study according to similar methods as described in OECD guideline 405 was performed with test substance Litsea cubeba essential oil. An amount of 0.1 ml of the undiluted test substance was instilled in one eye of three rabbits (no washing performed). Opacity, corneal swelling, chemosis, discharge, iritis, pannus and discomfort were checked in the treated animals on specific timepoints after instillation (15 minutes, 1 day, 2 days, 3 days and 7 days).
Litsea cubeba essential oil caused slight to moderate corneal lesions in two animals affecting between 25-75% of the corneal surface. These lesions were associated with slight to moderate corneal swelling. Opacity effects were also noted in two animals (not above 1). All animals developed slight to moderate conjunctivitis. All animals recovered within 7 days.
Under the conditions of this study, Litsea cubeba essential oil was found to induce slight to moderate conjunctivitis in all test animals, but recovery was completed within 7 days. These results were extrapolated to the current classification criteria based on expert judgement. It was concluded that the test substance does not need to be classified for eye irritation based on the criteria outlined in 1272/2008/EC (CLP).
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