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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 401 (Acute Oral Toxicity)
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:
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Aspartic acid
EC Number:
EC Name:
Aspartic acid
Cas Number:
Molecular formula:
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

Crj: CD(SD)
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
CMC (carboxymethyl cellulose)
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
No. of animals per sex per dose:

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 5 000 mg/kg bw
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.

Applicant's summary and conclusion