Registration Dossier

Administrative data

Description of key information

Acute oral toxicity (similar to OECD TG 401): 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:
January 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
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
Species:
rat
Strain:
not specified
Sex:
not specified
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.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Test was conducted according to methods similar to OECD guideline 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.

Based on the results obtained, it can be stated that in this study and under the experimental conditions reported, the test substance Petitgrain oil - citrus aurantum does not need to be classified as acute toxic via oral exposure, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).

Justification for classification or non-classification

Based on the available data, Petitgrain oil - citrus aurantium does not need to be classified as acute toxic via oral exposure in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).