Dodecairon strontium nonadecaoxide

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-09-15 to 2010-10-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data generated according to generally valid testing guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

combined with: Official Journal of the European Union. B.2. Acute Toxicity (Inhalation) and Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Second revised edition, 2007. Chapter 3.1 Acute Toxicity

Deviations:

yes

Remarks:

Minor deviations which do not impact significantly validity of the study.

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:

Dodecairon strontium nonadecaoxide

EC Number:

234-685-4

EC Name:

Dodecairon strontium nonadecaoxide

Cas Number:

12023-91-5

Molecular formula:

Fe12O19.Sr

IUPAC Name:

dodecairon(3+) strontium(2+) nonadecaoxidandiide

Details on test material:

- Name of test material (as cited in study report): Strontiumhexaferrite ("Manipermpulver")
- Analytical purity: 100 % industrial strontiumferrite
- Impurities (identity and concentrations): see section 1.2 of the IUCLID5.2-file
- Composition of test material, percentage of components: see section 1.2 of the IUCLid5.2-file
- Lot/batch No.: S16/179/08
- Expiration date of the lot/batch: 12/2999
- Stability under test conditions: stable
- Storage condition of test material: air-conditioned romm temperature, non-sterile

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: National University of Singapore, Centre for Animal Resources (CARE), 7 Perahu Road, Singapore 718836
- Age at study initiation: 11 - 13 weeks
- Weight at study initiation:ca. 237285 g (female), ca. 381 - 455 g (male)
- Fasting period before study: no data
- Housing: OptiMICE Caging IVC Systems for Rats
- Diet (e.g. ad libitum): PicoLab Rodent Labdiet 20 5053, ad libitum during oberservation period, withdrawn throughout exposure period.
- Water (e.g. ad libitum): Tap water, ad libitum, through plastic bottle


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): natural conditions

IN-LIFE DATES: From: 2010-09-10 To: 2010-09-30

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose/head only

Vehicle:

clean air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:TSE Nose (head) only Inhalation Exposure System, Project No 4223
- Exposure chamber volume: no data
- Method of holding animals in test chamber: no specific holding
- Source and rate of air: Flow air: 15.00 L/min, flow application 15.00 L/min
- Method of conditioning air: positive pressure difference
- System of generating particulates: The test substance was dried at 70 °C overnight before used for dust cake generation. No other pre-treatment was conducted before administration.
- Method of particle size determination: Cascade impactor 0.5 L/min
- Treatment of exhaust air: removed
- Temperature, humidity, pressure in air chamber: 30.6 - 31.9 °C, 10.6 - 11.4 % relatrive humidity, oxygen percentage 21.02 - 21.22 %

TEST ATMOSPHERE
- Brief description of analytical method used: Measurement of actual concentration by gravimetry method through a filtration unit connected to one of the exposure port
- Samples taken from breathing zone: yes/no

VEHICLE
not applicable

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 1,70 µm MMAD (mass median aerodynamic diamter) with 2.29 GSD (geometric standrad deviation)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): see above

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: According to OECD Guideline for the testing of Chemicals 403, the limit dose is 5 mg /L or the maximum attainable concentration for solid substance (dust). The limit dose is normally used for the test substances that the toxicity or mortality is not expected. Thus, limit dose of 5 mg /L or the maximum attainable concentration of the test item was selected based on the information provided by the sponsor.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Gravimetry method through a filtration unit connected to one of the exposure port

Duration of exposure:

ca. 4 h

Concentrations:

Actual maximum attainable concentration of the test substance:
Measurement 1 (mg /L) Measurement 2 (mg / L) Measurement 3 (mg / L) Average (mg/L)
0.55 0.62 0.66 0.61

No. of animals per sex per dose:

10 (5 male, 5 female)

Control animals:

no

Details on study design:

- Duration of observation period following administration: after 1 d, 3 d, 7 d and 14 d
- Frequency of observations and weighing: see above
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: body weight, observations

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating conc.

Effect level:

> 0.61 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality

Clinical signs:

other: No adverse effect was observed throughout the observation period.

Body weight:

no adverse effects.

Gross pathology:

No necropsy findings related to the test substance strontium ferrite

Any other information on results incl. tables

Body weight (bw, in gram) and body weight changes (change, in gram) of each animal during observation period

 

Group No	Animal ID	16-Sep-2010 Dosing day (Day 0)	17-Sep-2010  (Day 1)		19-Sep-2010 (Day 3)		23-Sep-2010 (Day 7)		30-Sep-2010 (Endpoint Day)
			Bw	Change	Bw	Change	Bw	Change	Bw	Change
Female	219103186-12-00- F1	264.8	268.2	+3.4	258.5	-9.7	261.9	+3.4	264.6	+2.7
	219103186-12-00- F2	273.3	283.4	+10.1	277.6	-5.8	285.0	+7.4	287.6	+2.6
	219103186-12-00- F3	278.4	290.6	+12.2	280.7	-9.9	292.2	+11.5	294.9	+2.7
	219103186-12-00- F4	236.7	239.0	+2.3	237.6	-1.4	244.6	+7.0	242.4	-2.2
	219103186-12-00- F5	284.5	297.2	+12.7	284.0	-13.2	293.0	+9.0	309.6	+16.6

 

Group No	Animal ID	16-Sep-2010 Dosing day (Day 0)	17-Sep-2010  (Day 1)		19-Sep-2010 (Day 3)		23-Sep-2010 (Day 7)		30-Sep-2010 (Endpoint Day)
			Bw	Change	Bw	Change	Bw	Change	Bw	Change
Male	219103186-12-00- M1	446.1	477.2	+31.1	473.9	-3.3	486.5	+12.6	520.0	+33.5
	219103186-12-00- M2	430.8	451.2	+20.4	450.8	-0.4	464.4	+13.6	493.8	+29.4
	219103186-12-00- M3	380.8	403.6	+22.8	403.8	-0.2	419.3	+15.5	450.0	+30.7
	219103186-12-00- M4	414.4	422.3	+7.9	433.0	+10.7	439.3	+6.3	488.1	+48.8
	219103186-12-00- M5	455.4	474.4	+19.0	462.7	-11.7	473.6	+10.9	480.0	+6.4

 

 

Gross necropsy was conducted on all the animals on the termination day. The necropsy finding and evaluation on all the animals were as follows:

Group No	Animal ID	Necropsy finding	Evaluation
Female	219103186-12-00- F1	No necropsy finding	Nil
	219103186-12-00- F2	Scattered patchy area in dark-red color in left lobe of lung. Texture of lung tissue looks rough	The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance
	219103186-12-00- F3	Patchy area in dark-red color in lower part of left lobe of lung. Lymph node 1 x 3 mm under the right lobe of thymus adjacent to trachea	The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance
	219103186-12-00- F4	Lymph node 1 x 2.5 mm under right lobe of thymus. Patchy area in dark-red color in right cranial lobe of lung	The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance
	219103186-12-00- F5	No necropsy finding	Nil

 

Group No	Animal ID	Necropsy finding	Evaluation
Male	219103186-12-00- M1	No necropsy finding	Nil
	219103186-12-00- M2	Black spots with about 0.5-1 mm in diameter on the surface of each lobe of lung. Lymph node 1 x 3 mm under the right lobe of thymus adjacent to trachea	The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance
	219103186-12-00- M3	Scattered patchy area in dark-red color in right caudal lobe and left lobe. Lymph nodes 1 x 2.5 mm under right lobe of thymus and 1.5 x 1.5 mm adjacent to left lobe of thymus	The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance
	219103186-12-00- M4	Two black spots with 0.5-1 mm in diameter on the left lobe of lung.	The necropsy finding was considered to be caused by carbon dioxide euthanization but not administration of test substance
	219103186-12-00- M5	No necropsy finding	Nil

                 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Strontium ferrite did not show any inhaltive toxicity when being administered with the limit dose of 5 mg/L (resulting in an average attainable concentration of 0.61 mg/L) according to OECD Guideline 403. No higher test concentrationw as achievable due to the substance properties.

a) No animal died during the 14-day observation period
b) No adverse effects were observed on the animals throughout the observation period
c) The necropsy finding was observed at the endpoint day and considered to be caused by carbon dioxide euthanization but not administration of test substance.
Hence, exposing the test item to rats for 4 hours using TSE Nose (head) only Exposure System, no acute inhalation toxicity was observed at the maximum attainable concentration of 0.61 mg/L.

Based on the above results strontium ferrite did not show acute inhalation toxicity at the maximum attainable concentration of 0.61 mg/L.

Executive summary:

The acute inhalation toxicity of strontium ferrite was assessed in a limit test according to OECD 403 and UN-GHS. The technically achievable maximum concentration of 5 mg/L resulted in an actual average concentration of 0.61 mg/L which was apllied to Sprague Dawley rats. The exposure period was 4 hours followed by an observation period of 14 days. No mortalities or other adverse effects were observed.

Based on the above results strontium ferrite did not show acute inhalation toxicity at the maximum attainable concentration of 0.61 mg/L. Strontium ferrite showed to be non-toxic via the inhalative route in this test.