Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']hydroxyferrate(2-)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

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 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium feredetate

EC Number:

239-802-2

EC Name:

Sodium feredetate

Cas Number:

15708-41-5

Molecular formula:

C10H12N2O8FeNa

IUPAC Name:

Sodium; 2-[2-(bis(carboxylatomethyl)amino)ethyl-(carboxylatomethyl)amino]acetate; iron(+3) cation

Constituent 2

Reference substance name:

FeNaEDTA

IUPAC Name:

FeNaEDTA

Details on test material:

Product brand: Sigma
Lot: 016K0107
Iron by ICP-AES: 14.4%
Sodium by ICP-AES: 6.1%
EDTA content: 69.9%

Test animals

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 51 days(males), 65 days (females)
- Weight at study initiation: 214 - 250 g
- Fasting period before study: 24 h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 55 +/-15%
- Photoperiod (hrs dark / hrs light): 12/12 hours

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: water

Details on inhalation exposure:

As no dust aerosol could be generated, the test item was dissolved in water to a 5.7% solution (the approximate limit of solubility).This solution was used to generate a nominal aerosol concentration of 55.56 mg/L air.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

nominal concentration: 55.56 mg/L air
actual concentration 2.75 +/- 0.19 mg/L air

No. of animals per sex per dose:

5 per sex per concentration

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.75 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: technically maximum attainable concentration

Mortality:

none

Clinical signs:

other: none

Body weight:

All animals gained the expected body weight.

Gross pathology:

No pathological findings

Any other information on results incl. tables

nominal concentration	actual concentration	mass median aerodynamic diameter	respirable amount particle size ≤4 µm	respirable amount particle size ≤4 µm
[µL/L air]	[mg/L air]	[µm]	[mg/L air]	[%]
55.56	2.75	2.730	1.21	44.1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LC50 (rat, 4h) > 2.75 +/- 0.19 mg/L (technically maximum attainable concentration)

Executive summary:

In an acute inhalation toxicity study according to OECD guideline 403 a group of 5 rats per sex was exposed to an aerosol concentration of 2.75 +/-0.19 mg/L air (technically maximum attainable concentration) for 4h by the inhalation route. The MMAD was 2.73 um and 44.1% of the mass fraction was <= 4 um. No adverse effects were noted, there were no clinical signs, no effects on body weight and no adverse findings at final necropsy after a 14 days observation period. The 4-h LC₅₀ exceeded 2.75 +/- 0.19 mg/L air.