Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to methods similar to OECD 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are acceptable as basic data.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Federal Hazardous Substance Act (FHSA)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Mandarin italian oil
- Lot/batch No.: confidential

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: healthy male Wistar Albino rats
- Weight at study initiation: 20-250 g (in general)
- Fasting period before study: 16-20 hours
- Housing: 5 per cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: Fresh Purina Rat Chow (Diet #5012) ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
no data
Doses:
single dose of 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: animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Frequency of observations and weighing: daily observations
Statistics:
The LD50 and 95% confidence intervals were calculated (if possible) by the method of Litchfield and Wilcoxon (1949) or Horn (1956).

Results and discussion

Preliminary study:
No animals died at an initial dose of 5.0 g/kg bw.
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0/10
Clinical signs:
no reactions observed
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

Distribution of Mortality

 Observation day 10  11  12  13  14 
 No. of Deaths  0  0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 in rats is > 5000 mg/kg bw under the conditions of this test. The substance does not have to be classified according to the EU classification criteria outlined in 1272/2008/EC and 67/548/EEC.
Executive summary:

In this acute oral toxicity study, a single dose of 5000 mg/kg bw Mandarin oil was given orally to 10 male Wistar rats. Animals were observed 3 -4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects. No deaths occurred, resulting in a LD50 > 5000 mg/kg bw. The substance does not have to be classified according to the EU classification criteria outlined in 1272/2008/EC and 67/548/EEC.