L-aspartic acid, sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

sodium 2-amino-3-carboxypropanoate

Cas Number:

323194-76-9

Molecular formula:

C4H7NO4.xNa

IUPAC Name:

sodium 2-amino-3-carboxypropanoate

Test material form:

solid: particulate/powder

Details on test material:

Name: L-aspartic acid, sodium salt monohydrate 1
Batch/Lot number: Z201125/ VG29848563
CAS number: 323194-76-9
Anhydrous substance name: L-aspartic acid, sodium salt, CAS: 17090-93-6
Appearance: Solid, white, crystalline powder
Purity: 98%
Expiry date: 24 November 2022
Storage conditions: Room temperature (15-25 ºC), protected from humidity (tight closed
container)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain: Han:WIST rats
Source: Toxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok tere 4B
Hygienic level at supplier: SPF
Hygienic level during the study: Standard housing conditions
Justification of strain: The Wistar rat as a rodent is one of the standard strains for
acute toxicity studies
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant animals
Age of animals at dosing: Young adult rats, approx. 10 weeks old
Body weight range at dosing: 185-193 g. The maximum difference of individual animal
weights from the mean of the treatment group did not exceed
20%.
Acclimatisation period: At least 22 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Details on oral exposure:

The night before treatment, the animals were fasted. Food, but not water, was withheld overnight. Animals were weighed before dosing. A single oral gavage administration was performed using a dose volume of 10 mL/kg bw. Food was replaced 3 hours after the treatment.

Doses:

Initially three animals were treated at the starting dose of 2000 mg/kg bw (Group 1). As no mortality was observed in this group, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in this confirmatory dose group, therefore no further testing was required according to the criteria for termination given in Annex 2d of OECD Guideline No. 423.

No. of animals per sex per dose:

6 female animals / dose

Control animals:

no

Details on study design:

Initially three animals were treated at the starting dose of 2000 mg/kg bw (Group 1). As no mortality was observed in this group, a confirmatory group (Group 2) was treated at the same
dose level. No mortality was observed in this confirmatory dose group, therefore no further testing was required according to the criteria for termination given in Annex 2d of OECD Guideline No. 423.

Statistics:

The method used was not intended to allow the calculation of a precise LD50 value.
The test item was classified according to the Globally Harmonized Classification System (GHS
(rev. 9) 2021).
The frequency of the clinical symptoms was summarised in tabular form. The mean of the body
weight and body weight gain were calculated by Excel spreadsheet software. Necropsy findings
were described and summarised in tabular form.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

95% CL:

>= 4.9 - <= 6.6

Mortality:

L-aspartic acid, sodium salt monohydrate did not cause mortality at 2000 mg/kg bw.

Clinical signs:

other: All animals were symptom-free during the 14-day observation period at a dose level of 2000 mg/kg bw.

Body weight:

other body weight observations

Remarks:

There were no effects on body weight or body weight gain that could be attributed to treatment with the test item. Individual body weights and body weight gains are presented in Appendix 3

Gross pathology:

There were no macroscopic changes seen at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test item
L-aspartic acid, sodium salt monohydrate was found to be above 2000 mg/kg bw in female Han:WIST rats.

According to the GHS criteria, L-aspartic acid, sodium salt monohydrate can be ranked as "Unclassified" for acute oral exposure.

Executive summary:

A single dose oral treatment was performed with L-aspartic acid, sodium salt monohydrate
according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No
440/2008 of 30 May 2008, B.1.tris) in Han:WIST rats.
Two groups of three female rats were treated with the test item at a dose level of
2000 mg/kg body weight.
The treatment was carried out by gavage for each animal after an overnight food withdrawal.
Food was made available again 3 hours after the treatment. The test item was administered in
distilled water, at a concentration of 200 mg/mL and at a dose volume of 10 mL/kg bw.
Clinical observations were performed at once during the first 30 minutes, 1, 2, 3, 4 and 6 hours
after dosing and daily for 14 days thereafter. Body weight was measured on Days 0 (prior to
dosing), 7 and 14 (prior to necropsy). All animals were subjected to a necropsy and a
macroscopic examination.

Under the conditions of this study, the acute oral LD50 value of the test item
L-aspartic acid, sodium salt monohydrate was found to be above 2000 mg/kg bw in
female Han:WIST rats.
According to the GHS criteria, L-aspartic acid, sodium salt monohydrate can be ranked as
"Unclassified" for acute oral exposure.