Sodium hydrogen L-aspartate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-01-04 to 2017-03-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium (S)-2-aminobutanedioic acid monohydrate

Cas Number:

323194-76-9

Molecular formula:

C4H8NO5.Na

IUPAC Name:

Sodium (S)-2-aminobutanedioic acid monohydrate

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 163 g (146 g - 174 g)
- Fasting period before study: 17 to 20 hours before start of treatment until 4 hours after administration.
- Housing: during acclimation period: 3 animals/cage, type IV Makrolon cages with a shelter on softwood bedding material (ABEDD LTE E-001, ABEDD LAB&VET Service GmbH, Austria) and with play tunnels (Ref. 14153, Plexx BV, Netherlands); starting 1 day before treatment: single, type III Makrolon cages with shelter and play tunnel on softwood bedding material.
- Diet: ad libitum, maintenance diet (VI534, ssniff Spezialdiaten GmbH, Germany)
- Water: ad libitum, community water, changed at least three times per week.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8 - 23.0
- Humidity (%): 39.7 - 63.2

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.25 % aqueous hydroxypropylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: well tolerated and established standard vehicle

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the chemical properties of the test item, mortality was not expected at the highest starting dose of 2000 mg/kg bw. Therefore, the study was started with 2000 mg/kg bw in three female rats and continued with further three females at 2000 mg/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1st series 3 females, 2nd series 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of treatment, each animal was observed for mortality and for symptoms of intoxication. On the following days, the rats were examined once daily. All animals were weighed before treatment (day 1) and on day 2, 4, 6, 8, 11, 13 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological investigation

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen.

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

No organ alterations were identified during the gross pathological examination.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 was determined to be > 2000 mg/kg bw in rats.

Executive summary:

A study was conducted to evaluate the acute oral toxicity of the test substance in rats according to OECD 423. The test substance was administered by gavage in a dose of 2000 mg/kg bw to a total of 6 female animals (2 sequential test were performed with 3 rats each). During the observation period of 14 days no mortality occurred and no signs of toxicity were detected. Pathological examinations revealed no changes. The LD50 for acute oral toxicity was established to be > 2000 mg/kg bw in rats.

The experiment was performed with the test item. The limit dose for the anhydrated form was calculated accordingly. An LD50(anhydrate) of > 1780.5 mg/kg bw was calculated. However, it was assumed, that the LD50(test item) of > 2000 mg/kg bw is also applicable to the anhydrated form.