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EC number: 289-612-9 | CAS number: 89957-91-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus bergamia risso, 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>10000 mg/kg bw (similar to OECD guideline 401)
Acute dermal toxicity: LD50>20000 mg/kg bw (similar to OECD guideline 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:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD guideline 401 and was performed pre-GLP. A concise description of the protocol is available and only mortality data are reported. Although concise, report is valid for acute toxicity assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Study was performed prior to implementation of OECD guideline 401. Methodology is comparable, though limited information on study protocol and test outcomes are available.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150-250grams
- Fasting period before study: 18 hrs prior to dosing
ENVIRONMENTAL CONDITIONS
No further information provided - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- - Concentration in vehicle: 2500, 5000 and 10000 mg/kg bw
- Doses:
- 1 dose at t=0
- No. of animals per sex per dose:
- 6 male rats per dose group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: no
- Other examinations performed: animals were examined for general toxic effects - Statistics:
- No data provided.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2 rats in the 10000 mg/kg bw dose group died within 1 day after administration.
- Clinical signs:
- other: No data provided.
- Gross pathology:
- No data provided.
- Other findings:
- Depression was observed. No further description provided.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of Bergamot oil in rats was established at exceeding 10000 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:
In an acute toxicity study, performed similar to OECD 401, male albino rats were exposed to bergamot oil (furocoumarin free quality). Rats were divided in 3 groups of 6 animals and were exposed via oral gavage to doses of resp. 2500, 5000 or 10000 mg/kg bw. Test animals were observed until 7 days after dosing. Within day 1 after dosing two rats in the 10000 mg/kg bw dose group died. No necropsies were performed. The oral LD50 value of Bergamot oil in rats was established at exceeding 10000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria as outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
Reference
Cumulative Mortality | ||||||||||
Dose (mg/kg bw) | Immediately | 1 hrs. | 4 hrs. | 1 day | 2 days | 3 days | 4 days | 5 days | 6 days | 7 days |
2500 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
10000 | 0 | 0 | 0 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
Table 1. cumulative mortality of male albino rats after administration of bergamot oil by oral gavage.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD guideline 402 and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Study was performed prior to implementation of OECD guideline 401 but methodology used is regarded comparable.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:1400-1750 grams
ENVIRONMENTAL CONDITIONS
No data available - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: Saran wrap and bandages
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test material was removed (method unspecified)
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):20,000 mg/kg bw
VEHICLE
No vehicle was used - Duration of exposure:
- 24 hrs
- Doses:
- 20000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals, sex unknown
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: animals were observed daily for signs of systemic toxicity; body weight gain and dermal erythema and/or edema was scored daily.
- Necropsy of survivors performed: gross autopsy at termination of the study (day 7)
- Other examinations performed: on day 5 blood samples were taken for hematology and clinical chemistry. Hematology included: erythrocyte, leucocyte and differential leucocyte counts; hematocrit and hemaglobin assessment. Clinical chemistry included serum glutamic oxaloacetic transaminase (SGOT); glucose; blood urea nitrogen (BUN); serum alkinase phosphatase (SAP); total serum protein; serum albumin; bilirubin; lactic acid dehydrogenase (LDH); cholesterol, serum calcium; serum phosphate and uric acid. - Statistics:
- No data available
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: All subject showed mild erythema following the 24-hour exposure period, but edema was not observed. Erythema persisted in all three animals during the experimental period.
- Gross pathology:
- No gross signs of toxicity were observed.
- Other findings:
- Hematology and clinical chemistry were within normal limits and comparable to control values.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 value of Bergamot oil in rabbits was established at exceeding 20000 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:
In an acute dermal toxicity test, performed according to a method comparable to OECD guideline 402, three albino rabbits were exposed to bergamot oil. Test animals were partially shaved. Bergamot oil was applied to the shaved skin under occlusion at an undiluted dosage of 20000 mg/kg bw. After 24 hours exposure, excess oil was removed and animals were observed for 7 days. Body weight, systemic toxicity and dermal irritation were recorded daily. On day 5 blood was drawn to determine hematology and clinical chemistry. At day 7, all animals were sacrificed and gross pathology was performed.
Bergamot oil did not produce mortality under the conditions of this study. All subjects developed mild erythema but edema was not observed. There were no gross signs of systemic toxicity and body weight gain, hematology and clinical chemistry were within normal limits and comparable to control values. Under the conditions of this study, the LD50 for dermal toxicity was established at > 20000 mg/kg bw. The substance therefore does not have to be classified according to the classification criteria as outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 20 000 mg/kg bw
Additional information
Acute oral toxicity
The key study was an acute toxicity study, performed similar to OECD guideline 401, in which three groups of six male albino rats were exposed via oral gavage to doses of respectively 2500, 5000 or 10000 mg/kg bw of bergamot oil (furocoumarin free quality). Within day 1 after dosing two rats in the 10000 mg/kg bw dose group died. Based on these results, the oral LD50 value of Bergamot oil in rats was established at exceeding 10000 mg/kg bw, under the conditions of this study.
Acute dermal toxicity
The key study was an acute dermal toxicity test, performed according to a method comparable to OECD guideline 402, in which three albino rabbits were exposed to bergamot oil. Bergamot oil was applied under occlusion at an undiluted dosage of 20000 mg/kg bw. Bergamot oil did not produce mortality under the conditions of this study. Based on these results, the LD50 for dermal toxicity was established at > 20000 mg/kg bw under the conditions of this study.
Justification for selection of acute toxicity – oral endpoint
The selected study is the key study for this endpoint.
Justification for selection of acute toxicity – inhalation endpoint
Oral and dermal acute tox data available.
Justification for selection of acute toxicity – dermal endpoint
The selected study is the key study for this endpoint.
Justification for classification or non-classification
Based on the available acute oral toxicity study, Bergamot oil does not have to be classified according to the classification criteria as outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
Based on the available acute dermal toxicity study, Bergamot oil does not have to be classified according to the classification criteria as outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
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