L-Aspartic acid, N,N'-1,2-ethanediylbis-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 December 2001 to 17 January 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

-

EC Number:

439-840-1

EC Name:

-

Cas Number:

20846-91-7

Molecular formula:

C10H16N2O8

IUPAC Name:

(2S)-2-[(2-{[(1S)-1,2-dicarboxyethyl]amino}ethyl)amino]butanedioic acid

Details on test material:

- Name of test material (as cited in study report): EDDS acid (under code)
- Substance type: technical product
- Physical state: solid
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study: overnight
- Housing: in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 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
- Justification for choice of vehicle: the oral route was predicted to be the most likely route of exposure

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: as recommended by OECD Guideline 423

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1/2, 1, 2 and 4 hr after dosing, then daily
- Frequency of weighing: once prior to dosing, then every 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination following necropsy

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: CL not applicable

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a GLP study carried out according to OECD Guideline 423 (and EU Method B.1), the acute oral LD50 for EDDS acid was determined to be greater than 2 g/kg bw in male and female rats.

Executive summary:

In a GLP study carried out according to OECD Guideline 423 (and EU Method B.1), three male and three female Sprage-Dawley rats were given a single dose of 2 g/kg bw EDDS acid via oral gavage. Rats were observed for overt signs of toxicity ½, 1, 2 and 4 hr following dosing, then once daily for fourteen days. Body weight was recorded prior to dosing (day 0), then on days 7 and 14. All animals were sacrificed after 14 days, and were subject to external and internal gross pathological examination. The occurrence of any macroscopic abnormalities was recorded.

No deaths or overt signs of systemic toxicity were observed throughout the experiment. Following sacrifice and examination of major organs on day 14, no macroscopic abnormalities were observed. All animals gained weight over the study period as expected.

In conclusion, the acute oral LD50 for EDDS acid was determined to be greater than 2 g/kg bw in male and female rats.

According to EU CLP and DSD regulations, EDDS acid would not be classified as acutely toxic by the oral route under the conditions of this test.