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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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
Guideline:
other: Federal Hazardous Substance Act (FHSA)
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
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

Constituent 1
Reference substance name:
Mandarin oil
IUPAC Name:
Mandarin oil
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 or test system 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:
other: no reactions observed
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.