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EC number: 284-515-8 | CAS number: 84929-31-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus limonum, Rutaceae.
- 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:
- July 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Very concise report, but the study seems reliable. No data on environmental conditions. No Guideline followed and study not performed under GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- An Acute Dermal Toxicity Limit test was performed as a standard acute method. Six male/female rabbits were prepared by clipping their trunks free from hair. Two areas on the back of each rabbit were selected: one area of skin was abraded; the remaining area was left intact. A dose of 5 ml/kg of liquid Lemon oil was applied to the skin of each of a group of rabbits. Liquid test material was delivered under a rubber sleeve by using a hypodermic syringe; then the sleeve was covered with Webril padding. The rabbits were fitted with a collar to prevent the removal of the wrappings. 24 hours later, the binders were removed, and the local dermal reactions were scored according to the method of Draize. Toxic effects, dermal reactions, and mortality were recorded daily for 14 days. A necropsy was performed on animals that died during the course of the study and on those animals which were killed (by air embolism) at termination.
- GLP compliance:
- no
Test material
- Reference substance name:
- Lemon, ext.
- EC Number:
- 284-515-8
- EC Name:
- Lemon, ext.
- Cas Number:
- 84929-31-7
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
- IUPAC Name:
- Essential oil of lemon obtained from the peel of Citrus limonum (Rutaceae) by expression and/or distillation, including cold pressed, distilled, terpenes and essence qualities
- Reference substance name:
- Lemon oil
- IUPAC Name:
- Lemon oil
- Details on test material:
- - Name of test material (as cited in study report): Lemon oil
- Physical state: Liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5-3.0 kg
- Housing: Individually
- Diet (e.g. ad libitum): Commercial diet
- Water (e.g. ad libitum): Ad libitum
ENVIRONMENTAL CONDITIONS: No data
IN-LIFE DATES: No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 hours and 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Not defined
- % coverage: 10% (240 cm2)
- Type of wrap if used: Rubber sleeve with Webril padding
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after 24 hours the binders were removed
SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Time point:
- other: 24 hours
- Score:
- >= 2 - <= 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: 6/6 animals
- Irritation parameter:
- edema score
- Time point:
- other: 24 hours
- Score:
- >= 1 - <= 3
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: 4/6 animals
- Irritant / corrosive response data:
- Skin irritation:
- Erythema score: between 2-4 in all animals
- Edema score: between 1-3 in 4 animals
- Discoloration: noted in 1 animal
- Scaling: noted in 5 animals
- Eschar formation: noted in 5 animals - Other effects:
- 1 out of 6 animals died during study.
Any other information on results incl. tables
Classification of skin irritation is based on acute dermal toxicity test. No tissue damage observed at termination.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- An Acute Dermal Toxicity Limit test was performed as a standard acute method. As no detailed scoring data is available, it is not possible to classify lemon oil according to the EU classification criteria outlined in 67/548/EEC and 1272/2008. However, the available scores at 24 hrs indicate lemon oil should be considered irritating to the skin.
- Executive summary:
Skin irritation potential of lemon oil was determined in an acute dermal toxicity limit test, which was performed as a standard acute method. Six male/female rabbits were prepared by clipping their trunks free from hair. Two areas on the back of each rabbit were selected: one area of skin was abraded; the remaining area was left intact. A dose of 5 ml/kg of liquid Lemon oil was applied to the skin of each of a group of rabbits. The test material was delivered under a rubber sleeve by using a hypodermic syringe; then the sleeve was covered with Webril padding. The rabbits were fitted with a collar to prevent the removal of the wrappings. The binders were removed 24 hours later, and the local dermal reactions were scored according to the method of Draize. Toxic effects, dermal reactions, and mortality were recorded daily for 14 days. A necropsy was performed on animals that died during the course of the study and on those animals which were killed (by air embolism) at termination.
Observed skin irritation was as follows: erythema score: between 2-4 in all animals; edema score: between 1-3 in 4 animals; Discoloration: noted in 1 animal; Scaling: noted in 5 animals; Eschar formation: noted in 5 animals. 1 out of 6 animals died during study. As no detailed scoring data is available, it is not possible to classify lemon oil according to the EU classification criteria outlined in 67/548/EEC and 1272/2008. However, the available scores at 24 hrs indicate lemon oil should be considered irritating to the skin.
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