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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study Initiation Date : 29 September 2021
Experimental Starting Date : 30 September 2021
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Reference substance name:
Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)
EC Number:
Cas Number:
Molecular formula:
It cannot be provided.
Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)
Test material form:
Details on test material:
Batch number: SV210602R4001

Test animals

Details on test animals or test system and environmental conditions:
3 animals per Step (total 12 animals)
Age at treatment: 9-10 weeks

Administration / exposure

Route of administration:
oral: gavage
corn oil
Details on oral exposure:
The dose volume was 10 mL/kg body weight. Feed was offered after 3 to 4 hours of dosing.
Step I and Step I- confirmation: 300 mg/kg
Step II and Step II- confirmation: 2000 mg/kg
No. of animals per sex per dose:
Control animals:

Results and discussion

Effect levels
Key result
Dose descriptor:
LD50 cut-off
Effect level:
5 000 mg/kg bw
Based on:
test mat.
No mortality
Clinical signs:
Body weight:
other body weight observations
No body weight changes
Gross pathology:
No gross pathology

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Based on the results of the experiment, it is concluded that the LD50 cut off value for the test item is 5000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guidelines for Testing of Chemicals (No. 423, Section 4: Health Effects) on conduct of “Acute Oral Toxicity - Acute Toxic Class Method” and classified as “Category 5 or Unclassified (2000 < ATE ≤ 5000)” as per the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Executive summary:

The test item, ESTERI METILICI ACIDI GRASSI DA OLIO ESSEBIOCHLOR45 was evaluated for Acute Oral Toxicity in Sprague Dawley rats.
A starting dose of 300 mg/kg body weight was selected from the four fixed dosen levels of 5, 50, 300 and 2000 mg/kg body weight, since there is no information available for the test item. A total of 12 females (3 females for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All the animals of Step-I and Step-I confirmation were administered with 300 mg/kg body weight and Step-II and Step-II confirmation were administered with 2000 mg/kg body weight of the test item by oral route. All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 mins, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Body weights were recorded at receipt, on day 1 before test item administration, on day 8 and 15 during the observation period. At the end of observation period, all the animals were humanely sacrificed by carbon dioxide asphyxiation, subjected to necropsy and gross pathological examination.
In Step-I and Step-I confirmation, the animals dosed with 300 mg/kg body weight did not revealed any clinical signs of toxicity and no mortality was observed. Also in Step-II and Step-II confirmation, the animals dosed with 2000 mg/kg body weight did not revealed any clinical signs of toxicity and no mortality was observed. No treatment related changes were observed in body weight and percent change in body weight with respect to day 1 at 300 mg/kg body weight and 2000 mg/kg body weight. All the animals revealed physiologically normal increase in the body weight. No gross pathological changes were observed in any of the animals at 300 mg/kg body weight and 2000 mg/kg body weight.