Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
CAS #
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Petitgarin oil, Petitgrain oil (Paraguay), Petitgrain oil (Bigarade) and Petitgrain oil (Terpeneless)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 75-112 Petitgrain Bigarde Oil

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals in total
Control animals:
no
Details on study design:
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: symptomatology.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Based on CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Under the conditions of this study, Petitgrain oil - citrus aurantum does not need to be classified for acute oral toxicity, based on Based on CLP criteria (EC 1272/2008 and its updates).
Executive summary:

In an acute oral toxicity study 5 rats were given asingle oral dose of 5000 mg/kg bw Petitgrain Bigarde Oil. No mortality or clinical signs were noted. The Oral LD50 was established to be higher than 5000 mg/kg bw. This study was performed according to the 401 OECD Guideline. Under the conditions of this study, Petitgrain oil - citrus aurantum does not need to be classified for acute oral toxicity, based on Based on CLP criteria (EC 1272/2008 and its updates).