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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

Referenceopen allclose all

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:
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. certificate)
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 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:
- 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 with 2.0 g/kg within four hours of dosing (refer to Table 1, attached).
- Pallor of the extremities was observed in all rats treated with 5.0 g/kg within four hours of dosing (refer to Table 1, attached).
- Diarrhoea was seen in females treated at 2.0 g/kg and in all rats treated at the high dose level within four hours of dosing (refer to Table 1, attached).
- Appearance and behaviour showed recovery to be complete by day 3.
Body weight:
- Slightly low bodyweight gains were recorded on day 8 for all males and two females at the high dose level.
- Other rats achieved anticipated bodyweight gains throughout the study.
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 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:
No clinical signs were observed.
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

None

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.

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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