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EC number: 232-433-8 | CAS number: 8028-48-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus sinensis, 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 / corrosion, other
- Remarks:
- in vivo study was perfomed on rabbits
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 January 2003 - 02 February 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
Test material
- Reference substance name:
- Orange, sweet, ext.
- EC Number:
- 232-433-8
- EC Name:
- Orange, sweet, ext.
- Cas Number:
- 8028-48-6
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molcular weight, and structural formula cannot be given.
- IUPAC Name:
- Essential oil of orange obtained from the peel of Citrus sinensis (Rutaceae) by expression and/or distillation, including cold pressed, distilled, terpenes and essence qualities
- Reference substance name:
- Cold pressed Orange oil
- IUPAC Name:
- Cold pressed Orange oil
- Details on test material:
- - Name of test material (as cited in study report): Cold pressed Orange oil
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste- 40260 Linxe, France
- Age at study initiation: no data
- Weight at study initiation: 2.30, 2.69 and 2.70 kg
- Housing: in individual boxes installed in conventional air conditioned animal husbanding
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: 7 to 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 25 - 51
- Air changes (per hr): conventional air conditioned
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, 0.5ml of distilled water on the left flank of each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100% (undiltued) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour and then 24, 48 and 72 hours after removal of the patch, and thereafter daily for 12 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE:
- Area of exposure: undamaged skin area on the right flank of each animal
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE: no data
SCORING SYSTEM: in compliance with OECD guideline 404, 1992. The skin reactions (Erythema and Eschar formation / Edema formation) were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- Animal #1 showed slight dryness at day 2 and 9; dryness at day 7 and 8; roughtless, loss of litheness from day 3 to 6. The other 2 animals showed slight dryness at day 11; dryness at day 10; roughtless, loss of litheness from day 2 to 9.
24 hours after the test product application, a slight to moderate erythema associated with a moderate oedema was noted on the treated area. The oedematous reaction was totally reversible the 6th day of the test and the erythematous reaction between the 8th and the 11th day of the test. - Other effects:
- The body weight of the animals was within the range commonly recorded for this strain.
Any other information on results incl. tables
The authors conclude that according to the classification established in the Journal Officiel de la Republique Francaise, dated February 21st, 1982, the results obtained, in these experimental conditions, enabled to conclude that the test product, COLD PRESSED ORANGE OIL, according to the scales of interpretation retained, is irritant to skin (Primary Skin Irritation (Psi) = 3.5).
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- CLP criteria not met
- Conclusions:
- Some erythema and oedema was observed in a skin irritation study according to OECD404, however according to EU criteria outlined in 1272/2008 (GHS/CLP), the substance does not have to be classified as irritating.
- Executive summary:
A skin irritation study was conducted according to OECD guideline 404, 1992, using the test material Cold Pressed Orange Oil on the intact skin of 3 male albino rabbits. Each test site was treated with 0.5 ml of the undiluted test material and was semioccluded for 4 hours. Observations for dermal irritation were made at 1 hour, and then 24, 48 and 72 hours after removal of the patch, and thereafter daily for 12 days. The scoring system was in compliance with OECD 404. The skin reactions (Erythema and Eschar formation/Edema formation) were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
The mean Erythea/Eschar scores, calculated from the numerical values given to the skin irritation of each animal observed at the 24, 48, and 72 hour were 2.0, 1.7, and 2.0. The mean Oedema scores were 2.0, 1.3, and 1.3. Based on these results and according to EU criteria, outlined in 1272/2008 (GHS/CLP), the substance does not have to be classified as irritating.
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