Dodecairon strontium nonadecaoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-05-12 to 2010-07-29

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

Minor deviations not impacting 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:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: NUS CARE, 7 Perahu Road, Agri-Bio Park, Singapore 718836
- Age at study initiation: ca. 8 weeks
- Weight at study initiation: 200 - 238 g
- Fasting period before study: overnight. Food, but not water was withheld.
- Housing: OptiMice caging System
- Diet (e.g. ad libitum): LabDiet 5053-PicoLab Rodent Diet 20
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Preparation of the test substance:
Water for injection was added to 5 g of test sample to a total volume of 20 ml. The final concentration was 250 mg/l.
The above test substance was shaken by hand to maintain the homogeneity during withdrawal into the syringe.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30',2 h, 4 h, 8 h, 24 h and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died before the endpoint, i.e. 14 d after dosing

Clinical signs:

other: No toxicity effect was observed in all animals.

Gross pathology:

Focal sub-capsular fat was found in the right kidney of 1 test animal and in the left kidney of 1 other test animal. There was no pathologic significance to the kidney sub-capsular fat foci found in both animals during the necropsy.

Other findings:

None.

Any other information on results incl. tables

Observation of each test animal

 

Group	Animal ID	Observation during 14-day period
Group 1	219103186-03-00-1	No adverse effects observed
	219103186-03-00-2	No adverse effects observed
	219103186-03-00-3	No adverse effects observed

 

Group	Animal ID	Observation during 14-day period
Group 2	219103186-03-00-4	No adverse effects observed
	219103186-03-00-5	No adverse effects observed
	219103186-03-00-6	No adverse effects observed

 

Body weight (BW, in gram) and body weight changes (change, in gram) of each animal

 

Group	Animal ID	BW before dosing (18 May 10)	BW on Day 7 (25 May 10)	BW on Day 14 (01 Jun 10)
Group 1	219103186-03-00-1	225	255 Change: +30	266 Change: +11
	219103186-03-00-2	238	267 Change: +29	294 Change: +27
	219103186-03-00-3	200	223 Change: +23	235 Change: +12

 

Group	Animal ID	BW before dosing (20 May 10)	BW on Day 7 (27 May 10)	BW on Day 14 (01 Jun 10)
Group 2	219103186-03-00-4	210	236 Change: +26	251 Change: +15
	219103186-03-00-5	234	253 Change: +19	266 Change: +13
	219103186-03-00-6	212	224 Change: +12	239 Change: +15

 

No body weight loss was found in all animals.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results and UN-GHS for acute toxicity hazard categories, the acute oral toxicity of strontium ferrite is considered as Category 5 or unclassified; the LD50 cut-off value of strontium ferrite is > 5000 mg/kg body weight.
Based on the results and EU-GHS (CLP) or acute toxicity hazard categories, the acute oral toxicity of strontium ferrite is considered as unclassified. The LD 50 cut-off value of strontium ferrite is > 2000 mg/kg body weight.

Executive summary:

The acute oral toxicity of strontium ferrite was assessed in a limit test according to OECD 423. 2000 mg/kg bw of the test item were adminstered orally to Wistar-rats. Observation period was 14 days. No mortalities or other adverse effects were observed. It can therefore be concluded that the oral LD50 is above the tested concentration of 2000 mg/kg b.w.