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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Pre-GLP study
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system 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
- Frequency of observations: Daily
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
None
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:

Schinus Molle 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. Daily observations were made for an period of 14 days. None of the animals died during the 14-day oberservation period. Furthermore, no subtance related clinical signs were observed. 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

Schinus Molle 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. Daily observations were made for an period of 14 days. None of the animals died during the 14-day oberservation period. Furthermore, no subtance related clinical signs were observed. The LD50 was determined to be higher than 5000 mg/kg bw.

 

In the same study, Schinus Molle oil was tested for acute dermal toxicity in a study performed similar to OECD TG 402. Ten rabbits were exposed to the test substance. Animals received a dose of 5000 mg/kg bw. Daily observations were made for a period of 14 days. None of the animals died during the 14-day observation period. Furthermore, no substance related clinical signs were observed. Slight redness, moderate redness, slight edema, and moderate edema were observed in 4, 2, 1, and 1 animal out of 10, respectively. The LD50 was determined to be higher than 5000 mg/kg bw (Moreno, 1974).

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).