L-Aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt (1:3)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 April to 12 May 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

416-530-4

EC Name:

-

Cas Number:

178949-82-1

Molecular formula:

C10H13N2Na3O8

IUPAC Name:

trisodium 2-({2-[(1-carboxy-2-carboxylatoethyl)amino]ethyl}amino)butanedioate

Details on test material:

- Name of test material (as cited in study report): trisodium EDDS (under code)
- Substance type: technical product
- Physical state: solid, white powder
- Purity test date: no data
- Lot/batch No.: 02
- Expiration date of the lot/batch: 01 January 1998
- Stability under test conditions: stable in double-distilled water
- Storage condition of test material: room temperature, in dark in dry condition

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd, Wölferstrasse 4, CH-4414 F¿llinsdorf, Switzerland
- Age at study initiation: males, 8 weeks; females, 10 weeks
- Weight at study initiation: males, 195.5-203.0 g; females, 169.7-181.7 g
- Fasting period before study: 16.5 h
- Housing: Makrolon type-3 cages on softwood bedding
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle:included in list of recommended vehicles
- Purity: double-distilled

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): homogenised in vehicle, kept in suspension during dosing using a magnetic stirrer

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed four times on day of dosing (last check, 5 h after treatment), then daily. Weighed pre-dosing, then weekly
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No signs of toxicity were observed.

Gross pathology:

No treatment-related organ abnormalities were observed on macroscopic examination

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a GLP study conducted according to OECD Guideline 401 (available at the time), an acute oral LD50 value of >2000 mg/kg bw was determined for trisodium EDDS in male and female rats following gavage administration.

Executive summary:

In a GLP study conducted according to OECD Guideline 401 (available at the time), trisodium EDDS was studied for acute toxicity after single oral administration to five rats of each sex. The test substance was given by gavage as an aqueous suspension at a dose of 2000 mg/kg bw.

None of the animals died or showed signs of toxicity during the 14-day observation period, and the body weight of the animals was not adversely affected. At necropsy, no abnormalities were evident in the rats upon macroscopic examination.

An acute oral LD50 value of >2000 mg/kg bw was determined for trisodium EDDS in male and female rats. According to EU CLP regulation, trisodium EDDS would not be classified as acutely toxic by the oral route under the conditions of this test.