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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed according to a guideline similar to OECD401 and in accordance with GLP. Materials and methods and results are reported clearly.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to guideline
Guideline:
other: Hagan E.C., "Acute Toxicity", p17-25, 1975
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Eucalyptus Citriodora
IUPAC Name:
Eucalyptus Citriodora
Details on test material:
- Name of test material (as cited in study report): Eucalyptus Citriodora
- Specific gravity: 0.89

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: licenced dealer, no details available
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: between 200 and 300 grams bodyweight
- Fasting period before study: 18 hours
- Housing: galvanized cages with indirect bedding
- Diet (e.g. ad libitum): growth and maintanance ration from commercial producer, ad libitum
- Water (e.g. ad libitum): ad libitium
- Acclimation period: at least 2 days prior to test initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled room
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: no details available
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 rats (male)
5 rats (female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 3, 9, 24 hours after treatment and daily thereafter for a total of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: observed for signs of pharmacololgic activity and drug toxicity
Statistics:
Not relevant

Results and discussion

Preliminary study:
Not relevant
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
24 hours after treatment, mortality was observed in two males and one female (30% mortality rate).
Gross pathology:
Internal organs on superficial examination appeared normal

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the oral LD50 value of Eucalyptus Citriodora oil in rats was established to be >5000 mg/kg body weight. 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:

An acute oral toxicity test was performed according to methods similar to OECD401 and under GLP conditions. A single 5000 mg/kg bw dose of eucalyptus citriodora oil was administered by oral gavage to 5 male and 5 female Wistar albino rats. The animals were observed for signs of pharmacologic activity, drug toxicity and mortality on 1, 3, 9, 24 hours after treatment and daily thereafter for a total of 14 days. Mortality was observed 24 hours after treatment in two males and one female. Internal organs on superficial examination appeared normal.

24 hours after treatment, mortality was observed in two males and one female (30% mortality rate). Based on these results, the oral LD50 value of Eucalyptus Citriodora oil in rats was established to be >5000 mg/kg body weight. Therefore the substance does not need to be classified in accordance with the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).