Registration Dossier
Registration Dossier
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EC number: 947-570-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In two acute oral studies (K2), the oral LD50 was found to be superior to 5 g/kg bw
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:
- 9 June 1988 to 16 November 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Meets generally accepted scientific standards, well documented and acceptable for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- not applicable
- 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 (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- see confidential
- Species:
- rat
- Strain:
- CD-1
- 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 doses
- 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. - Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 mg/kg bw
- Mortality:
- No deaths took place following administration of test material at 2.0 or 5.0 g/kg bodyweight
- Clinical signs:
- other: - All rats showed pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethergy and increased salivation within three hours of dosing (refer to Table 1, attached). - Decreased respiratory rate was seen in all rats treated wit
- Gross pathology:
- - Terminal autopsy findings were normal.
- Other findings:
- None
- 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.
- Executive summary:
- The acute median lethal oral dose (LD50) to rats of the test material was found to be > 5.0 g/kg bodyweight.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
- Principles of method if other than guideline:
- Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- No data
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Doses:
- 5000 mg/kg bw
- 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: Observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute oral toxicity study (limit test), ten rats were given a single oral dose of Oil Patchouly at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.
No mortality or clinical signs was observed. In this study, the oral LD50 of Oil Patchouly was higher than 5000 mg/kg bw in rats.
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Referenceopen allclose all
None
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute oral toxicity study, dose of 3000 and 5000 mg/kg bw of the test substance was given to groups of male and females rats (6/dose). Observations for toxic symptoms and mortality were made for 14 days, and the survivors were sacrificed without autopsy. No deaths were observed.
In another acute oral toxicity study (limit test), ten rats were given a single oral dose of Patchouly oil at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.
0 deaths was observed on 10 animals. No others signs of toxicity were observed. In this study, the oral LD50 was higher than 5000 mg/kg bw in rats.
Under the experimental conditions of these studies, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Justification for classification or non-classification
Self classification:
Acute toxicity via Oral route:
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5000 mg/kg bw
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