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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was not conducted according to a guideline or under GLP conditions. The report is concise, but results are acceptable as basic data.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Five male and five female rats received a limit dose of bitter orange oil by the oral route. The animals were observed for 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Orange Oil Bitter
IUPAC Name:
Orange Oil Bitter
Details on test material:
- Name of test material (as cited in study report): Orange Bitter
- Physical state: Liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
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.
Remarks on result:
other: Mortality: 0/10
Mortality:
No mortality observed
Clinical signs:
other: No clinical signs reported
Gross pathology:
No unusual findings
Other findings:
No data

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, no mortality occurred as a result of a one time oral dose of 5000 mg/kg. Therefore, the LD50 for Orange Bitter was established to be >5000 mg/kg bw and the substance does not need to be classified for acute toxicity based on the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
Executive summary:

Five male and five female rats received a dose of 5000 mg/kg bw Orange Bitter by the oral route. The animals were observed for 14 days.

None of the animals died as a result of treatment and necropsy revealed no unusual findings.

Under the conditions of this study, the LD50 for Orange Bitter was established to be >5000 mg/kg bw and the substance does not need to be classified for acute toxicity based on the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.