Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 10th to 25th, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted December 17th, 2001

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

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:

480-340-8

EC Name:

-

Cas Number:

156157-97-0

Molecular formula:

C12H30Cl2N2Na2O14

IUPAC Name:

Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

SPF Caw

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53490 Le Geneste St Isle - France).
- Age at study initiation: 8 weeks old.
- Weight at study initiation: 179 - 204 g.
- Fasting period before study: food was removed at day one and then redistributed 4 hours after the item administration.
- Housing: solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Diet: ad libitum.
- Water: tap water from public distribution system, ad libitum.
- Acclimation period: at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 23 °C.
- Humidity: 41 - 70 %.
- Air changes: ten changes per hour.
- Photoperiod: 12 hrs dark/12 hrs light.
- Other: conventional air conditioned animal husbandry.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VOLUME APPLIED: 10 ml/kg b.w.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

six female rats (three animals per step).

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days.
- Type and frequency of observations: systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions. The observations were performed by comparison with the control animals standing in the same environment. Mortality report and observations were carried every day for 14 days; the first day the animals were observed at 30 min, 1 hr, 3 hrs, 4 hrs and then daily thereafter. Observations include: spontaneous activity, preyer's reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance.
- Frequency of weighing: on day 0 (just before the administration of the test item) then on day 2, day 7 and day 14.
- Necropsy: on day 14 animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic obcervations were reported individually. Only those organs likely to be modified in cases of acute toxicity were performed. Those presenting macroscopic anomalies were removed and preserved for microscopic examinations.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occured.

Clinical signs:

decrease of spontaneous activity in the treated animals (6/6) from 3 hrs after administration. The animals recovered a normal activity the 2nd day of the test.

Body weight:

body weight evolution remained normal throught the study.

Gross pathology:

the macroscopical examination did not reveal any treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC) No.1272/2008.

Conclusions:

LD50 > 2000 mg/kg b.w.

Executive summary:

The acute oral toxicity of the test material in the female Sprague-Dawley strain rat was assessed in this limit acute toxic class test coducted according to the OECD Guideline 423 and EU Method B.1 tris. For this reason, three female rats were used in each step and they were given one single oral dose of the substance at dose level of 2000 mg/kg b.w. The animals were observed for fourteen days for signs for clinical signs, toxicity and for deaths. Body weights were recorded prior to dosing, weekly thereafter and at the end of the test. At the end of the test the survived animals were killed and were subjected to gross pathological examination.

No mortality occured and no macroscopic changes were observed. The animals showed normal bodyweight gain. The only observation was the decrease of spontaneous activity in the treated animals (6/6) from 3 hrs after administration. However, the animals recovered a normal activity the 2nd day of the test.

LD50 > 2000 mg/kg b.w.