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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb-May 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not performed according to GLP guideline but similar to OECD or EC guideline. No information on the purity is provided. However, the results are considered reliable for this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
purity not stated; no details on dosing
Principles of method if other than guideline:
Study performed according to the method described by Hagan, EC (Acute Toxicity, Appraisal of the safety of chemicals in food, drugs and cosmetics; The Association of Food and Drug Officials of the United States, 1959, pp 17-25).
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Nissui Marine Cholesterol
IUPAC Name:
Nissui Marine Cholesterol
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Nissui Marine Cholesterol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: suitable licensed dealer, not specified
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 202 to 240 grams
- Fasting period before study: 18 hours
- Housing: stainless steel cages with indirect bedding
- Diet: ad libitum, Lab Diet Certified Rodent Diet #5002
- Water: ad libitum
- Acclimation period: at least 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): monitored, not specified
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 28 Feb 2008 (males) or 3 May 2008 (females) To: 14 March 2008 (males) or 17 May 2008 (females)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing, mortality and clinical signs at 1, 3, 6 and 24 hours after dosing, and at least once daily therafter for a total of 14 days; initial and terminal body weights were recorded.
- Necropsy of survivors performed: yes
Statistics:
not performed, not required.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: No significant clinical signs were observed (mucoid diarrhea in 4 males at 3 hours after administration only).
Gross pathology:
no gross changes were observed
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Exposure to 2000 mg/kg bw cholesterol of male and female rats did not result in mortality.
Executive summary:

Sprague Dawley rats (5/sex) were given 2000 mg/kg bw cholesterol by oral gavage. Animals were observed for 14 days for mortality, clinical signs, and body weights were recorded at the start and at the end of the study. All animals survived the 14 day observation period. All animals gained weight, and no clinical signs or gross changes were observed. Based on the absence of mortality at the tested dose of 2000 mg/kg bw, cholesterol does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011)

- Regulation (EC) No 1272/2008 on clasification , labelling and packaging of substances and mixtures.