Aspartic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2010

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

1. Characterization of the test substance by the manufacturer was not performed under Good Laboratory Practice Standards. 2. The dosing preparation used in the study was not analyzed for stability, homogeneity, or accuracy of concentration. The procedures

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Aspartic acid

EC Number:

200-291-6

EC Name:

Aspartic acid

Cas Number:

56-84-8

Molecular formula:

C4H7NO4

IUPAC Name:

aspartic acid

Details on test material:

Substance Tested: ¿ L-Aspartic Acid
¿ 56-84-8 (CAS Number)
Haskell Number: 27761
Purity: ¿ 99.5%
Physical Characteristics: White solid

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

1. Housing
All animals were housed individually in suspended, stainless steel, wire-mesh cages.
2. Environmental Conditions
Animal rooms were maintained at a temperature of 18-26°C and a relative humidity of 30-70%. Animal rooms were artificially illuminated (fluorescent light) on an approximate 12-hour light/dark cycle.
3. Feed and Water
Tap water was available ad libitum. PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002 was available ad libitum except during the fasting period.
4. Identification
Each rat was assigned an animal number which was recorded on a card affixed to the cage. The rats were tail-marked, using a water-insoluble marker, with the animal number.
5. Quarantine
Rats were observed daily for general health and weighed at least once during the 6-day quarantine period.
6. Animal Health and Environmental Monitoring Program
As specified in the Haskell Laboratory animal health and environmental monitoring program, the following procedures are performed periodically to ensure that contaminant levels are below those that would be expected to impact the scientific integrity of the study:
¿ Water samples are analyzed for total bacterial counts, and the presence of coliforms, lead, and other contaminants.
¿ Samples from freshly washed cages and cage racks are analyzed to ensure adequate sanitation by the cagewashers.
Certified animal feed is used, guaranteed by the manufacturer to meet specified nutritional requirements and not to exceed stated maximum concentrations of key contaminants, including specified heavy metals, aflatoxin, chlorinated hydrocarbons, and organophosphates. The presence of these contaminants below the maximum concentration stated by the manufacturer would not be expected to impact the integrity of the study. The animal health and environmental monitoring program is administered by the attending laboratory animal veterinarian. Evaluation of these data did not indicate any conditions that affected the validity of the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Doses:

The rats were fasted approximately 18 hours prior to dosing. L-Aspartate was suspended in 0.5% aqueous methylcellulose on an as-is, weight per volume basis (approximately 15,000 mg test substance in 30 mL vehicle). The test substance was administered in a single oral dose by
gavage at a dose amount of 5000 mg/kg and a volume of 10 mL/kg body weight. The amount of dosing suspension administered to each animal was based on the animal¿s fasted body weight
determined on the day of dosing. The dosing suspension was stirred throughout the dosing
procedure to maintain homogeneity. The rats were approximately 10 weeks old on the day of
dosing.

No. of animals per sex per dose:

5

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

All rats survived for the duration of the study.

Clinical signs:

other: High carriage was observed in one male rat on the day of dosing. No clinical signs were observed in any of the other rats.

Gross pathology:

No gross lesions were found in the study.