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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
There were no signs of systemic toxicity.
Body weight:
Animals shows expected gains in body weight over study period.
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.