Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

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:
other: Well conducted study according to GLP; one remark: 44% of the particles was smaller than 4 micron, indicating that the MMAD was slightly above 4 micron (1-4 micron is required)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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 the aerosol of nominal 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 concentraion 2.75 +/- 0.19 mg/L air
No. of animals per sex per dose:
5
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: +/- 0.19, No mortalities.
Mortality:
none
Clinical signs:
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:
other: No classification needed
Remarks:
Migrated information
Conclusions:
LC50 (rat, 4h) exceeded 2.75 +/- 0.19 mg/L the 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 for 4h by the inhalation route. No adverse effects were noted, no clinical signs, no effects on body weight and no adverse findings at final necropsy after a 14 days observation period. It was noted that the MMAD was slight above 4 micron whereas 1 -4 micron is required.

The LC50(rat, dermal) exceeded 2.75 +/- 0.19 mg/L air.