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EC number: 289-904-6 | CAS number: 90045-43-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus paradisi M., 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
Acute oral toxicity:
LD50 > 5000 mg/kg bw (standard acute method, limit test; similar to OECD 401)
Acute dermal toxicity:
LD50 > 5000 mg/kg bw (standard acute method, limit test; similar to OECD 402)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are acceptable as basic data.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: healthy male Wistar albino rats
- Weight at study initiation: 200-250 g (in general)
- Fasting period before study: 16-20 hrs
- Housing: 5 per cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: Fresh Purina Rat Chow (Diet #5012), ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C):controlled
- Humidity (%):controlled
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Doses:
- single dose of 5 g/kg
- No. of animals per sex per dose:
- 10 male animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation
- Other examinations performed: symptomatology - Statistics:
- The LD50 and 95% confidence intervals were calculated if possible by the method of Litchfield and Wilcoxon (1949) or Horn (1956).
- Preliminary study:
- Not relevant
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 out of 10 rats died on day 1
- Clinical signs:
- other: No effects observed
- Gross pathology:
- Not performed
- Other findings:
- Necropsy was not performed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of grapefruit oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
- Executive summary:
A single 5000 mg/kg bw dose of grapefruit oil was administered orally to 10 rats. The test was conducted according to methods similar to OECD 401 (limit test) and was performed pre-GLP. The animals were observed for 14 days. One animal died on the first day. No symptoms were noted. The oral LD50 value of grapefruit oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
Reference
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are acceptable as basic data.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
TEST ANIMALS
- Weight at study initiation:2.0-3.0 kg (in general)
- Housing: 2 per cage in suspended wire mesh cages. Bedding was placed beneath the cages
- Diet: Fresh Purina Rabbit Chow (Diet #53-21) ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: abdomen
- % coverage: 10%
- Type of wrap if used: gauze patch, torsi wrapped with plastic and secured with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test site was wiped
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied: 5000 mg/kg bw - Duration of exposure:
- 24 hrs
- Doses:
- 5 g/kg
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation
- Necropsy of survivors performed: no
- Other examinations performed: symptomatology and skin irritation - Statistics:
- The LD50 and 95% confidence intervals were calculated (if possible).
- Preliminary study:
- Not relevant
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 out of 10 rabbits died on day 8
- Clinical signs:
- other: No effects observed
- Gross pathology:
- Not performed
- Other findings:
- Skin irritation:
Slight redness - 6/10
Moderate redness - 2/10
Slight edema - 7/10
Moderate edema - 3/10
No information on scoring system used. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 value of grapefruit oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
- Executive summary:
A single 5000 mg/kg bw dose of grapefruit oil was administered dermally to 10 rabbits. The test was conducted according to methods similar to OECD 402 (limit test) and was performed pre-GLP. The animals were observed for 14 days. One animal out of 10 died on day 8. Slight to moderate redness and oedema was noted in the majority of the animals. The dermal LD50 value of grapefruit oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
Reference
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Acute oral toxicity was tested in a standard acute limit test, in which a single dose of grapefruit oil (5000 mg/kg bw) was administered orally to 10 rats.
The animals were observed up to 14 days after application. One animal died on day 1. No other mortality was observed. The oral LD50 was established to be >5000 mg/kg bw.
Acute dermal toxicity was also tested in a standard acute limit test, in which 10 rabbits were exposed to a single dose of grapefruit oil (5000 mg/kg bw) dermally. The animals were observed up to 14 days after application. One animal died on day 9. No other mortality was observed. Slight to moderate redness and oedema was noted in the majority of the animals. The dermal LD50 was established to be > 5000 mg/kg bw.
Justification for classification or non-classification
Based on the available information, grapefruit oil has been shown to be of low acute toxicity when applied via the oral and dermal route. Therefore, the substance grapefruit oil does not need to be classified for acute toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS) and Annex VI of 67/548/EEC.
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