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Acute Toxicity: oral

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acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:

Materials and methods

Test guideline
according to guideline
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
not specified
GLP compliance:
Test type:
up-and-down procedure

Test material

Constituent 1
Reference substance name:
Algal oil
Algal oil
Test material form:
Specific details on test material used for the study:
ONC T-18 DHA-rich algal oil (lots no. 22630 and 22740; approximately 39–42% docosahexaenoic acid (DHA); total omega-3 fatty acids, approximately 41–44%; storage condition, frozen, -10 to -30 °C) was produced and received from Ocean Nutrition Canada Limited, Dartmouth, Nova Scotia, Canada. Ascorbyl palmitate and mixed natural tocopherols were added to the algal oil to prevent oxidation.

Test animals

Details on test animals or test system and environmental conditions:
Female Sprague–Dawley albino rats were obtained from Ace Animals, Inc., Boyertown, PA. The animals were housed individually in stainless steel cages in temperature-controlled and humidity-monitored quarters.

Administration / exposure

Route of administration:
other: oral intubation
unchanged (no vehicle)
5000 mg/kg of bodyweight
No. of animals per sex per dose:
Control animals:
Details on study design:
The study was conducted in accordance with U.S. Food and Drug Administration (21 CFR Part 58), and the OECD Principles of Good Laboratory Practice ENV/MC/CHEM (98)17). The study design was based on OECD Guideline 425 (OECD, 1997). One female rat was administered a single oral dosage of 5000 mg/kg DHA-rich algal oil/kg of body weight via oral intubation. Due to the absence of mortality in the first rat, two additional female rats received an identical single oral dose of the test article. Each animal was observed for signs of toxicity and behavioural changes for several hours after test article administration and once daily thereafter for 14 days. Mortality/moribundity checks were performed daily. Body weights were recorded before test article administration, at day 7, and at termination. On day 15, rats were killed, necropsies were performed, and any gross observations were recorded.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
No deaths occurred during the study.
Clinical signs:
None reported.
Body weight:
All animals gained body weight during the study.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Other findings:
Apart from diarrhoea and ano-genital staining observed in one rat at 5 h post-dosing, all animals appeared active and healthy over the 14-day observation period. There were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The acute oral LD50 in rats for DHA-rich algal oil has been estimated to be greater than 5000 mg/kg of body weight. Since the GHS criteria for classification are not met, the algal oil is not classified. The composition of menhaden oil is comparable to this oil. Therefore, menhaden oil is also not classified.
Executive summary:

In this publication by Schmitt et al. 2012 experiments regarding the toxicity of an algal oil are described. Acute oral toxicity was assessed by a guideline study according to OECD Guideline 425. There were no adverse effects observed during the study and LD50 of the test article was greater than 5,000 mg/kg of body weight in female rats. Since the GHS criteria for classification are not met, the algal oil is not classified. The composition of menhaden oil is comparable to this oil. Therefore, menhaden oil is also not classified.