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EC number: 939-227-3 | CAS number: -
- 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
The acute median lethal oral dose (LD50) to rats of the test material was found to be > 5.0 g/kg bodyweight.
Acute inhalation
Testing by the inhalation route in accordance with column 2 of Annex VIII of 1907/2006/EC, is considered to be inappropriate as exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance (0.94 Pa at 20°C) and/or the possibility of exposure to aerosols or droplets of an inhalable size.
Acute dermal toxicity
One acute dermal study with limited detail is available that suggests LD50(dermal)>5000mg/kg bw). This is supported by an acute oral toxicity study that suggests the substance is not acutely harmful (LD50>5000mg/kg). Potential for systemic exposure via ingestion is considered to be higher than exposure following contact with skin, therefore the existing data from exposure via contact with skin is considerd to be reliable and represents the worse case.
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:
- 1988-06-09 and 1988-06-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- A group of six rats (3 males and 3 females) was treated at 2.0 g/kg bodyweight and, based on the result of that dosing, a further group of six rats was dosed at 5.0 g/kg.
- GLP compliance:
- yes
- Test type:
- other: single dose
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, England
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 108-142 g
- Fasting: overnight prior to dosing and for approximately 4 hours after dosing.
- Housing: grouped by sex in metal cages with wire mesh floors.
- Diet: Standard laboratory rodent diet (Labsure LAD-1) ad libitum (see Appendix 1, attached)
- Water: ad libitum (see Appendix 2, attached, for results of routine chemical examination of water at source (Grafham Final Water) as conducted by Anglian Water Authority)
- Acclimation period: 8 days prior to start of study
ENVIRONMENTAL CONDITIONS
- Temperature: 21-24 ºC
- Humidity: mean value 67 %
- Air changes: approximately 15 per hour
- Photoperiod: controlled by a time switch to provide 12 hours artificial light in each 24 hour period. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The appropriate dose volume of the test substance was administered to each rat using a syringe and plastic catheter (8 choke)
- Doses:
- Single dose
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Each animal was identified by cage number and ear punching.
- Each cage was identified by a coloured label displaying the dose level, study schedule number and the initials of the study director.
- Animals were observed soon after dosing and at frequent intervals for the remainder of day one (a minimum period of five hours).
- On subsequent days the animals were observed once in the morning and again at the end of the experimental day.
- The latter observation was at approximately 16:30 hours on weekdays or 11:30 hours on Saturday and Sunday.
- Clinical signs were recorded at each observation.
- All animals were observed for 14 days after dosing.
- Nature, severity, approximate time of onset and duration of each toxic sign was recorded.
- Individual bodyweights of rats were recorded on days 1, 8 and 15.
- All animals were killed on day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination, which consisted of opening the abdominal and thoracic cavities.
- Macroscopic appearance of abnormal organs when present was recorded. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths took place following administration of test material at 2.0 or 5.0 g/kg bodyweight
- Clinical signs:
- diarrhoea
- lethargy (hypoactivity)
- salivation
- other: Pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling),decreased respiratory rate @2g/kg, pallor of the extremities @5g/kg.
- Gross pathology:
- - Terminal autopsy findings were normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of the test material was found to be > 5.0 g/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 000 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- no details provided
- Principles of method if other than guideline:
- A single dose of 5g/kg bw of the test item was administered to 7 rats and any signs of irritation recorded over a 14-day period.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- other: Not reported
- No. of animals per sex per dose:
- 7 animals were dosed with 5g/kg of test item
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following exposure of seven rabbits to 5g/kg bw of test substance there were no deaths. The substance is therefore estimated to have a LD50 of greater than 2000mg/kg bw.
- Executive summary:
Following exposure of seven rabbits to 5g/kg bw of test substance there were no deaths. The substance is therefore estimated to have a LD50 of greater than 2000mg/kg bw.
Classification in accordance with CLP is not required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- One acute dermal study with limited detail is available that suggests LD50(dermal)>5000mg/kg bw).
Additional information
Justification for selection of acute toxicity – oral endpoint
The acute median lethal oral dose (LD50) to rats of the test
material was found to be > 5.0 g/kg bodyweight.
Justification for selection of acute toxicity – inhalation endpoint
The oral and dermal LD50 levels for the substance have been
determined and both demonstrate relatively harmless levels of acute
toxicity >2000 mg/kg bw and therefore do not require labelling under
CLP. Testing by the inhalation route in accordance with column 2 of
Annex VIII of 1907/2006/EC, is therefore considered to be inappropriate
as exposure of humans via inhalation is unlikely taking into account the
vapour pressure of the substance (0.94 Pa at 20°C) and/or the
possibility of exposure to aerosols or droplets of an inhalable size.
Justification for selection of acute toxicity – dermal endpoint
One acute dermal study with limited detail is available that
suggests LD50(dermal)>5000mg/kg bw).
Systemic exposure to Patchouli, ext. via contact with skin is unlikley
to be more significant than exposure orally. Hence, the weight of
evidence from the acute oral toxicity data (LD50 greater than 5 g/kg bw)
where systemic exposure to Patchouli oil is considered to be higher than
dermal exposure plus the limited acute dermal study represents a worse
case assessment and the substance is considered not be acutely harmful
in contact with skin. Classification and labelling is therefore not
required.
Justification for classification or non-classification
The acute median lethal oral dose (LD50) to rats of the test material was found to be > 5.0 g/kg bodyweight, which is the maximum concentration for classification according to Regulation (EC) No 1272/2008.
One acute dermal study with limited detail is available that suggests LD50(dermal)>5000mg/kg bw). Systemic exposure to Patchouli, ext. via contact with skin is unlikely to be more significant than exposure orally. Hence, the weight of evidence from the acute oral toxicity data (LD50 greater than 5 g/kg bw) where systemic exposure to Patchouli oil is considered to be higher than dermal exposure plus the limited acute dermal study represents a worse case assessment and the substance is considered not be acutely harmful in contact with skin. Classification and labelling is therefore not required.
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