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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
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating (OECD404), although some effects were noted.
Eye irritation: not irritating (OECD405)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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 - 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. - 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.
- 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.
Reference
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).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- an in vivo study was performed with rabbits
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 January 2003 - 30 January 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Performed under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste- F40260 Linxe, France
- Age at study initiation: no data
- Weight at study initiation: 2.18, 2.49 and 2.59 kg
- Housing: in individual boxes
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: 8 to 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 26 -51
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% (undiltued) - Duration of treatment / exposure:
- at least 24 hours
- Observation period (in vivo):
- 1 hour after installation, and 24, 48 and 72 hours after, and thereafter daily for 9 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: no data
SCORING SYSTEM: The numerical scorings recorded were made in compliance with OECD guideline 405, 1987, scoring ocular lesions (corneal, iridic and conjunctival irritation). Ocular examinations were performed on both right and left eyes 1 hour after instillation and 24, 48 and 72 hours later. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal # 1, 2, and 3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal # 1, 2, and 3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- Animal #1, 2, and 3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal # 3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The ocular reactions observed during the study remained slight to moderate and only recorded at the conjunctivae level: slight redness in the 3 animals 1 hour after the test product administration and totally reversible between the 8th and the 9th day of the test, associated with a moderate chemosis 1 hour after the test product administration and totally reversible between the 7th and the 8th day of the test.
- Other effects:
- The body weight of the animals was within the range commonly recorded for this strain.
- Interpretation of results:
- other:
- Remarks:
- not irritating, CLP criteria not met
- Conclusions:
- In an eye irritation study performed according to OECD405, orange oil did not induce significant or irreversible damage to the rabbit eye. Based on these results and according to the EU criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS), Cold Pressed Orange Oil does not have to be classified and has no obligatory labelling requirement with respect to eye irritation in rabbits.
- Executive summary:
The primary eye irritation potential of Cold Pressed Orange Oil was investigated according to OECD test guideline no. 405, 1987. The test item was applied by instillation of 0.1 ml into one eye of each of 3 male New Zealand White rabbits.
The ocular reactions observed during the study remained slight to moderate and only recorded at the conjunctivae level. The mean score was calculated across the 3 scoring times for each animal for corneal opacity, iris lesion, redness and chemosis of the conjunctivae, separately, and was 0.0 for all three animals for corneal opacity and iris lesions, and 1.0 for reddening of the conjunctivae for all three animals. It is concluded that orange oil did not induce significant or irreversible damage to the rabbit eye. Based on these results and according to the EU criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS), Cold Pressed Orange Oil does not have to be classified and has no obligatory labelling requirement with respect to eye irritation in rabbits
Reference
The authors conclude that according to the classification established in the Journal Officiel de la République Française, dated July 10th, 1992, 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 slightly irritant for the eye (Maximum Ocular Irritation Index (Max. O.I.=14.0).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a skin irritation study according to OECD404, orange oil was applied on the intact skin of three albino rabbits. In all animals, erythema and edema was observed, mean scores being 2.0, 1.7, 2.0 for erythema, and 2.0, 1.3, and 1.3.
The primary eye irritation potential of orange oil was investigated in a study according to OECD405 in three male New Zealand White rabbits. Mean scores were 0.0 for corneal opacity and iris lesions, and 1.0 for reddening of the conjunctivae for all three animals
Effects on skin irritation/corrosion: non irritating
Justification for classification or non-classification
Based on the available information, orange oil has been shown to have some irritating properties when applied to the skin. However, according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS), orange oil does not have to be classified as skin irritant.
The results of the primary eye irritation test indicate that the substance orange oil does not need to be classified as eye irritant according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
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