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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity (similar to OECD TG 401): LD50 > 5000 mg/kg bw

Acute dermal toxicity (similar to OECD TG 402): LD50 > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to methods similar to OECD 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
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)
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Sherman-Wistar (albino)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: 24 hours
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
no data available
Doses:
5.0 g/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no
- Other examinations performed: symptomatology
Statistics:
no data
Preliminary study:
not applicable
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
0/10
Clinical signs:
other: Diuresis, mild depressant effects noted one-half hour after dosing. Two females exhibited signs of morbidity; however, recovery was complete the following day.
Gross pathology:
no data
Other findings:
no data

 Dosage level (g/kg) No. Rats Dosed  day 1  day 2  day 3  day 4  day 5  day 6  day 7  day 8  day 9  day 10  day 11  day 12  day 13  day 14  Mortality after 14 days 
 5.0 5 males  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0/5 
 5.0 5 females  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0/5 
Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LD50 of Tangerine oil in rats was > 5000 g/kg bw under the conditions of this test.
Executive summary:

An acute oral toxicity study was performed by administering 5000 mg/kg bw of the test substance directly into the stomach of five male and five female albino rats. During a fourteen day observation period, no deaths occured. The LD50 of Tangerine oil is > 5000 mg/kg bw under the conditions of this test. Therefore, the test substance does not need to be classified accoring to the EU classification criteria outlined in the CLP Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1971
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 reported clearly.
Qualifier:
according to guideline
Guideline:
other: Method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol.26, No. 155, P. 7336, 12 August 1961
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
5.0 g/kg bw
No. of animals per sex per dose:
6 (3 with intact skin, 3 with abraded skin)
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Preliminary study:
not applicable
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0/6
Clinical signs:
other: In 3 animals, dry cracked skin was noted.
Gross pathology:
no data
Other findings:
no data

 Dose (gram / kg)  No. Rabbits (Skin Intact) Mortality No. Rabbits (Skin Abraded)  Mortality 
 5.0 3 0/3  3  0/3 
Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LD50 of tangerine oil in rabbits was > 5000 mg/kg bw under the conditions of this test.
Executive summary:

To determine the percutaneous toxicity of Tangerine oil, an acute dermal toxicity study was performed on six albino rabbits according to a method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, August 1961. The LD50 of the test substance was > 5000 mg/kg bw. Therefore, the test substance does not have to be classified according to the EU classification criteria outlined in the CLP Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

For both acute oral and dermal toxicity, standard acute limit tests are available that are concisely reported. However, a consice description of the protocol is available and results are reported clearly, therefore the results of the study are acceptable as basic data.

In the acute oral toxicity study, Sherman-Wistar (albino) rats were exposed by gavage to a limit dose of 5000 mg/kg bw/day. No mortality was observed, therefore the LD50>5000 mg/kg.

In the acute dermal toxicity study rabbits were exposed to a limit dose of 5000 mg/kg bw/day. No mortality was observed, therefore the LD50>5000 mg/kg.

Justification for classification or non-classification

Based on the available information, tangerine oil has been shown to be of low acute toxicity when applied via the oral and dermal route. Therefore, the substance tangerine oil does not need to be classified for acute toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).