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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

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)
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:
Tangor, Murcote, ext.
EC Number:
297-672-2
EC Name:
Tangor, Murcote, ext.
Cas Number:
93686-22-7
Molecular formula:
This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molcular weight, and structural formula cannot be given.
IUPAC Name:
(4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene
Test material form:
liquid

Test animals

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

Administration / exposure

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

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
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

Any other information on results incl. tables

 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  0/5 
 5.0 5 females  0/5 

Applicant's summary and conclusion

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).