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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
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2 June 1992 - 30 June 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Performed under GLP, according to international guideline, test substance defined. Not all test details reported
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
not relevant - Oxygen conditions:
- aerobic
- Inoculum or test system:
- other: secondary effluent from an unacclimated activated sludge plant
- Details on inoculum:
- Secondary effluent from an unacclimated activated sludge plant at URL North.
Inoculum used was 10% by volume of the effluent, filtered through a Whatman filter paper (541) to remove coarse particluate matter. - Duration of test (contact time):
- 28 d
- Initial conc.:
- 10 mg/L
- Based on:
- DOC
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- Medium as proposed in 1988 OECD RIng Test on BIodegradation with deviation: Feriic chloride stock solution contained 0.25 g not 0.2 g. The EDTA stock solution contained 0.4 g and not 0.5 g.
100 ml medium in 160 ml vessels (hypovials)
Analysis of the headspace gas and liquid medium for CO2/DIC was performed on days 3,7,10,14,16,21,24,28, using a Ionics 555 Inorganic Carbon Analyser. - Preliminary study:
- not relevant
- Test performance:
- No data on reference substance. However, the inoculum activity was proven by the ready biodegradation of the test substance
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 60.5
- Sampling time:
- 14 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 72
- Sampling time:
- 28 d
- Remarks on result:
- other: 95% confidence 69.3 - 74.8 %
- Details on results:
- The biodegradation curve is attached. It is concluded that Orange oil florida is classified as readily (meeting the 10d-window) and ultimately biodegradable.
- Results with reference substance:
- no information
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test substance is readily biodegradable.
- Executive summary:
The substance 'Orange terpenes' (purity 96% limonene) was assessed in a test for ready biodegradation according to OECD TG 301B (CO2 production) under GLP. After 28 days the biodegradation was 72 % (95% confidence interval 69.3 - 74.8%). Thus the test substance is classified as readily biodegradable. The report does not present all test details and therefore the study is rated reliability 2.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 31 August 1990 - 28 September 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Performed under GLP, according to international guideline, test substance defined. Not all test details reported
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
not relevant - Oxygen conditions:
- aerobic
- Inoculum or test system:
- other: secondary effluent from an unacclimated activated sludge plant
- Details on inoculum:
- Secondary effluent from an unacclimated activated sludge plant at URL North.
Inoculum used was 10% by volume of the effluent, filtered through a Whatman filter paper (541) to remove coarse particluate matter. - Duration of test (contact time):
- 28 d
- Initial conc.:
- 10 mg/L
- Based on:
- DOC
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- Medium as proposed in 1988 OECD RIng Test on BIodegradation with deviation: Feriic chloride stock solution contained 0.25 g not 0.2 g. The EDTA stock solution contained 0.4 g and not 0.5 g.
100 ml medium in 160 ml vessels (hypovials)
Analysis of the headspace gas and liquid medium for CO2/DIC was performed on days 4,7,14,18,21,25,28, using a Ionics 555 Inorganic Carbon Analyser. - Preliminary study:
- not relevant
- Test performance:
- No data on reference substance. However, the inoculum activity was proven by the ready biodegradation of the test substance
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 62
- Sampling time:
- 14 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 83.4
- Sampling time:
- 28 d
- Remarks on result:
- other: 95% confidence 76.4 - 90.4 %
- Details on results:
- The biodegradation curve is attached. It is concluded that Orange oil florida is classified as readily (meeting the 10d-window) and ultimately biodegradable.
- Results with reference substance:
- no information
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test substance is readily biodegradable.
- Executive summary:
Orange oil was assessed in a test for ready biodegradation according to OECD TG 301B (CO2 production) under GLP. After 28 days the biodegradation was 83 % (95% confidence interval 76.4 - 90.4%). Thus the test substance is classified as readily biodegradable. The report does not present all test details and therefore the study is rated reliability 2.
- Endpoint:
- biodegradation in water: inherent biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 30/11/2007 - 07/01/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- performed under GLP
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 302 C (Inherent Biodegradability: Modified MITI Test (II))
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not relevant - Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Duration of test (contact time):
- 28 d
- Initial conc.:
- 31.6 - 35.7 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Reference substance:
- benzoic acid, sodium salt
- Remarks:
- Sigma-Aldrich , lot nr 02720
- Parameter:
- % degradation (O2 consumption)
- Value:
- 75
- Sampling time:
- 28 d
- Details on results:
- After 28d a mean degradation value of 75% of the test item was measured. An abiotical degradation of the test item can be excluded as there was no oxygen uptake within the abiotic control. The calculated "toxic effect" of the test item towards microorganisms at the concentration tested can be
neglected as the oxygen uptake within the test solution with the test item was higher than within that of the toxicity control. This special behaviour can be explained by the so-called diauxic effect (in the presence of a second carbon and energy source not always both components are degraded simultaneously as much as within the individual test solutions with the test or control item alone). As there was a degradation >60% of the test item, there is evidence of an inherent biodegradability. - Results with reference substance:
- The control item sodium benzoate was degraded 90% within 28d.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- inherently biodegradable
- Conclusions:
- Regarding the results obtained within this study the test item may be considered "inherently biodegradable".
- Executive summary:
"Orangenol WMB" was tested for biodegradability according to 'MITI-[II]-Test' (OECD Guideline 302C using a mixture of two natural inocula). The test was performed under GLP. The degradation process was followed by the oxygen uptake in the test solutions. After 28d a mean degradation value of 75% of the test item was measured. An abiotical degradation of the test item can be excluded as there was no oxygen uptake within the abiotoc control. The calculated "toxic effecf' of the test item towards microorganisms at the concentration tested can be neglected as the oxygen uptake within the test solution with the test item was higher than within that of the
toxicity control. This special behaviour can be explained by the so-called diauxic effect (in the presence of a second carbon and energy source not always both components are degraded simultaneously as much as within the individual test solutions with the test or control item alone). As there was a degradation >60% of the test item, there is evidence of an inherent biodegradability. Regarding the results obtained within this study the test item may be considered "inherently biodegradable". The control item sodium benzoate was degraded 90% within 28d. The threshold of ~60% was met within 6d of incubation. Therefore, the test is considered valid.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- other: constituent approach was followed.
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Orange Oil is a Natural Complex Substance (NCS). WIth 96% of the constituents of Orange oil known, this NCS can be considered as a well defined NCS. If the fraction of readily biodegradable constituents of the NCS exceeds 75%, the NCS itself is readily biodegradable as well.
- Justification for type of information:
- The conclusion for this NCS is based on the constituent approach as explained in the 'principles of the method' section
- Principles of method if other than guideline:
- Assessment of the Ready biodegradability of the known constituents; addition of the percentage of readily biodegradable constituents in the mixture gives the fraction of readily biodegradable substances. If this fraction exceeds 75%, the NCS is classified as 'readily biodegradable'.
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- other: the results originate from multiple test set-ups
- Duration of test (contact time):
- 28 d
- Key result
- Parameter:
- other:
- Value:
- >= 60
- Sampling time:
- 28 d
- Remarks on result:
- other: based on > 75% of the constituents being readily biodegradable
- Details on results:
- Details for all constituents are summarised in window "Any other information on results" and in attached document
- Validity criteria fulfilled:
- not applicable
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Orange oil is considered as readily biodegradable.
- Executive summary:
Orange oil is a Natural Complex Substance (NCS) for which 96% of the constituents is identified. Orange oil consists for 80% of d-limonene and a range of minor constituents. An assessment of the biodegradability of Orange oil was made based on the degradability of its constituents. The underlying assumption is that if the constituents of the NCS are readily biodegradable, the NCS itself is readily biodegradable as well.
With the exception of one minor constituent, for all constituents the available data are obtained in tests on the ready biodegradability. For one minor constituent the ready biodegradability is based on a structurally related substance.
The cut-off level for ready biodegradability of the NCS is derived from the approach used for the classification as R53 in the Preparations Directive 1999/45/EC and the CLP Regulation 1272/2008/EC. If more then 25% of a mixture is not readily biodegrable, the mixture is considered as not ready biodegradable. This implies that if more then 75% of the fraction is biodegradable, the mixture (in this case the Natural Complex Substance Orange oil) is to be considered ready biodegradable.
All known constituents, comprising 96% of the composition of this NCS, are in the category of ready biodegradable substances. Therefore, Orange oil is considered readily biodegradable.
Referenceopen allclose all
Summary of results of testing biodegradability according to OECD 302 C
Time (d) |
% Degradation |
|||||
TS 1 |
TS 2 |
TS 3 |
TS, Mean value |
Tox-control |
Sodium Benzoate |
|
0 |
0.0 |
0..0 |
0.0 |
0 |
0.0 |
0.0 |
0.8 |
3.8 |
4.2 |
3.3 |
4 |
15.6 |
6.3 |
2.0 |
7.5 |
10.7 |
9.4 |
9 |
20.2 |
36.2 |
2.9 |
22.5 |
25.8 |
17.9 |
22 |
20.9 |
47.6 |
3.9 |
27.9 |
36.6 |
24.6 |
30 |
26.2 |
54.4 |
4.9 |
30.9 |
45.2 |
29.6 |
35 |
33.8 |
58.1 |
5.9 |
33.6 |
49.0 |
32.7 |
38 |
38.0 |
61.6 |
6.9 |
36.4 |
51.2 |
35.5 |
41 |
40.4 |
65.9 |
7.8 |
38.4 |
52.4 |
37.3 |
43 |
41.5 |
69.0 |
8.8 |
40.9 |
54.3 |
39.8 |
45 |
42.5 |
73.8 |
9.9 |
43.8 |
56.7 |
42.8 |
48 |
44.0 |
79.7 |
10.7 |
45.5 |
58.3 |
44.2 |
49 |
44.9 |
82.7 |
11.8 |
47.5 |
60.6 |
46.1 |
51 |
45.8 |
85.1 |
12.9 |
49.5 |
62.2 |
48.1 |
53 |
47.2 |
86.9 |
13.9 |
51.0 |
63.9 |
49.9 |
55 |
48.4 |
88.0 |
14.8 |
52.4 |
65.2 |
51.9 |
56 |
49.6 |
89.3 |
16.0 |
53.5 |
67.4 |
55.0 |
59 |
51.3 |
90.2 |
17.0 |
54.1 |
69.9 |
57.6 |
61 |
52.5 |
90.6 |
17.9 |
55.2 |
72.7 |
59.9 |
63 |
53.6 |
90.6 |
19.0 |
56.4 |
75.4 |
61.4 |
64 |
55.1 |
90.8 |
20.0 |
57.4 |
77.7 |
62.4 |
66 |
56.6 |
90.6 |
21.0 |
58.9 |
79.8 |
64.0 |
68 |
58.4 |
90.8 |
22.0 |
59.8 |
80.7 |
64.6 |
68 |
59.3 |
90.8 |
23.0 |
60.6 |
81.7 |
65.7 |
69 |
60.5 |
90.8 |
24.0 |
61.7 |
83.5 |
66.8 |
71 |
61.3 |
90.4 |
25.0 |
62.8 |
85.4 |
68.2 |
72 |
61.9 |
90.4 |
26.0 |
63.4 |
86.7 |
69.1 |
73 |
62.6 |
90.4 |
27.0 |
64.1 |
88.1 |
69.8 |
74 |
62.8 |
90.6 |
28.0 |
64.6 |
89.7 |
71.0 |
75 |
63.4 |
90.2 |
Assessment of the biodegradability of ORANGE OIL:
Each of the identified constituents, totalling 96% of the composition, is readily biodegradable, see underlying data in table below.
Constituent |
Results of Ready biodegradation |
D-limonene C10H16 |
READILY BIODEGRADABLE: - Headspace CO2: 71.4% (Quest 1993). The biodegradability of perfume ingredients in the sealed vessel test. - MITI (I) / OECD 301C, improved for volatile substance: Limonene 14d - BOD: 41, 81, 98% Direct analysis: GC: 100%; TOC 50, 73, 81% (MITI 1980 http://www.safe.nite.go.jp/sitemap/db_map_e.html) - Readily biodegradable (Misra, G.; Pavlostathis, S. G.; Perdue, E. M.; Araujo, R. Applied Microbiology and Biotechnology (1996), 45(6), 831-838.)
|
Linalool |
READILY BIODEGRADABLE: - OECD 301C: 80% (Givaudan 1991) - OECD Modified 301B, sealed CO2: 97.1% (QUEST 1994) - Readily biodegradable (Misra, G.; Pavlostathis, S. G.; Perdue, E. M.; Araujo, R. Applied Microbiology and Biotechnology (1996), 45(6), 831-838.) - MITI (I) / OECD 301C: 28d - BOD: 90% Direct analysis: TOC 99% GC: 100%; (MITI 1996 http://www.safe.nite.go.jp/sitemap/db_map_e.html)
|
Octanal C8H16O
|
READILY BIODEGRADABLE: Read across from decanal
supported by prediction from EPISuite/ BIOWIN v4.10 (March 2009): readily biodegradable - yes |
Decanal C10H20O
|
READILY BIODEGRADABLE: - OECD 301D Closed Bottle test: BOD 66% (14d) AND (RIFM/Givaudan/Akzo Nobel: A. Lapczynski, D. Salvito, K. Jenner, R. Geerts, C. Van Ginkel: Ready biodegradability testing of volatile poorly water soluble fragrances; Possible pitfalls. Poster SETAC North America 29th Ann. Meeting Tampa, Fl, November 2008, http://rifm.org/doc/RIFM%20SETAC%20Tampa%20Poster%20112008.pdf)
|
Myrcene C10H16O |
READILY BIODEGRADABLE: - OECD 310 Carbon Dioxide Headspace test: CO2 production: 73% (Van Ginkel 2009) - MITI (I) / OECD 301C, improved for volatile substance: 14d - BOD: 86% Direct analysis: GC: 99%; TOC: 97% (MITI 1987: http://www.safe.nite.go.jp/sitemap/db_map_e.html)
|
alpha-Pinene C10H16
|
READILY BIODEGRADABLE: - OECD301B, sealed vessels: 62% (28d), 70% (42d) (Astra Zeneca, 2001, ECB PBT#84 http://ecb.jrc.ec.europa.eu/documents/PBT_EVALUATION/PBT_sum084_CAS_91770-80-8.pdf). - MITI (I) / OECD 301C: 28d - BOD: 91, 90, 95% Direct analysis: GC: 100, 100, 100% (MITI 2007: http://www.safe.nite.go.jp/sitemap/db_map_e.html)
|
alpha-Terpineol C10H18O |
READILY BIODEGRADABLE: - OECD 310 Carbon Dioxide Headspace test, CO2 production: 80% degradation for Isomeric terpineol mixtures [CAS 8000-41-7] e.g. mixture containing 86% alpha, 11% gamma & 1% beta (Van Ginkel 2008).
Primary degradation and complete mineralisation demonstrated using soil inoculum under aerobic conditions (Misra, G.; Pavlostathis, S. G.; Perdue, E. M.; Araujo, R. Applied Microbiology and Biotechnology (1996), 45(6), 831-838.)
|
Citral C10H16O |
READILY BIODEGRADABLE: - Modified 301B, sealed vessels CO2: 92.1% in 28 d (Quest 1994) - MITI (I) / OECD 301C,improved for volatile substance (Citral is mixture of neral and geranial): 28d - BOD: 92% Direct analysis: TOC: 78%; GC: 100% The test substance formed 6-Methyl-5-hepten-2-one (2-2480) and Geranic acid in (Water + Test Substance) system. (MITI 1991: http://www.safe.nite.go.jp/sitemap/db_map_e.html)
Supported by prediction from EPISuite/ BIOWIN v4.10 (March 2009): readily biodegradable - yes |
Citronellal C10H18O |
OECD 301F: 61% (28d), 51% in 10d-window (Givaudan 1994)
Supported by prediction from EPISuite/ BIOWIN v4.10 (March 2009): readily biodegradable - yes |
|
Fraction of NCS READILY BIODEGRADABLE |
The complete asssessment is added attached to this study record. Studies mentioned by Company Name are included in the RIFM database.
Description of key information
All known constituents of Orange oil, comprising 96% of the composition of this NCS, are in the category of readily biodegradable substances. Therefore, Orange oil is considered readily biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
Orange oil is a Natural Complex Substance (NCS) typically consisting for 80% of d-limonene and a range of minor constituents. Therefore the asssessment of the biodegradability of Orange oil is based on its constituents. The assumption is that if the constituents of the NCS are readily biodegradable, the NCS itself is readily biodegradable as well. All known constituents, comprising 96% of the composition of this NCS, are in the category of ready biodegradable substances. Therefore, Orange oil is considered ready biodegradable.
This finding is supported by the results of two studies on the ready biodegradation of Orange oil florida and on Orange terpenes (King 1993, 1992) showing a mineralisation (CO2 production) of 83 and 72% after 28 days , respectively (Rel. 2 due to concise reporting). Moreover a high degree of biodegradation found in an inherent biodegradability study with Orange oil (Orangenöl, Lebertz, 2008) carried out according to OECD TG 302 C (MITI [II]) with a reliability of 1. This test revealed a biodegradation percentage of 75% (O2 consumption) in 28 days.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.