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Administrative data

Description of key information

Acute oral toxicity (tested in a study 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:
25 July 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
not specified
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
No symptoms observed during the 14-day observation period.
Gross pathology:
No pathology reported.
Interpretation of results:
other: Not acute toxic
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
The acute oral toxicity test showed a LD50 of > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the oral route.
Executive summary:

Geranium oil is tested for acute oral toxicity in a study performed similar to OECD TG 401. Ten rats were exposed to the test substance via oral gavage. Animals received a dose of 5000 mg/kg bw. The animals were observed for clinical signs for 14 days. In this study none of the animals died and no clinical signs were observed during the 14 -day observation period. The LD50 was determined to be higher than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity

Geranium oil is tested for acute oral toxicity in a study performed similar to OECD TG 401. Ten rats were exposed to the test substance via oral gavage. Animals received a dose of 5000 mg/kg bw. The animals were observed for clinical signs for 14 days. In this study none of the animals died and no clinical signs were observed during the 14-day observation period. The LD50 was determined to be higher than 5000 mg/kg bw .

Acute dermal toxicity

Geranium oil was tested in an acute dermal toxicity study similar to OECD TG 402. Sixteen rabbits were exposed to the test substance via dermal application. Four animals per dose were exposed to 1250, 2500, and 5000 mg/kg bw. The animals were observed for clinical signs and mortality for 14 days. No mortality was observed in the 1250 mg/kg bw dose group. In the 2500 mg/kg bw dose and 5000 mg/kg bw dose group 2 animals died. Based on these results it is not possible to determine an exact LD50, but as two animals died at 2500 and 5000 mg/kg bw it ise expected that the LD50 is higher than 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available data, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in EU CLP (EC no 1272/2008 and its amendments).