Dodecairon strontium nonadecaoxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 Apr. 2010 - 22 Apr. 2010

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Minor deviations not impacting vailiduity of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute 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 room temperature, non-sterile

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species Rats
Strain Wistar
Microbiological status Specific Pathogen Free (SPF)
Age 6 to 8 weeks old
Sex Male, body weight 290g to 390g
Female, body weight 180g to 230g
Number Male, 5
Female, 5
Source
National University of Singapore
Centre for Animal Resources (CARE)
7 Perahu Road
Singapore 718836

Housing Condition OptiMICE Caging Systems for rats
Temperature 18 - 22oC
Humidity 30 - 70%
Food Harlan Teklad T2018 Global Rodent Diet
Water Tap water

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Remarks:

The test item was moistened with water for injection .

Details on dermal exposure:

The test animals were acclimatised for at least 5 days before the test was conducted.
Approximately 24 hours before the test, fur in the dorsal area of each animal’s trunk was shaved. The shaved area was not less than 10 percent of the body surface.
On the dosing day, the animals were weighed prior to dosing. The test substance was administered by topical application on the shaved area of each animal. The dose level was 2000 mg/kg based on the body weight of each animal.
The test item was moistened with water for injection and applied uniformly over the shaved area which was approximately 10 percent of the total surface area. The test item was then held in contact with the skin using a gauze patch and occlusive dressing. The exposure was conducted for 24 h.
At the end of exposure period, residual test item was removed and cleaned carefully with water.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw based on weight of the test item

No. of animals per sex per dose:

5 female and male each.

Control animals:

no

Details on study design:

The observation of adverse effects was conducted on each animal during the first 30 minutes, periodically during the first 24 hours (with special attention during the first 4 hours), and periodically thereafter, up to 14 days. The body weight of each animal was measured every 3 to 7 days.
On the termination day, all the test animals were euthanized by CO2 inhalation. Gross necropsy was conducted on all the test animal.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during dosing and observation period.

Clinical signs:

other: No adverse effect was observed in all animals during dosing and observation period.

Gross pathology:

Necropsy was conducted on all the test animals on the termination day. No abnormality was observed on all the test animals.

Other findings:

Not applicable

Any other information on results incl. tables

Dose level of each test animal and adverse effects

 

Group No	Animal ID	Body weight (g)	Amount of test item used for dosing (g)	Dose level (based on weight of the test item, mg/kg) by body weight	Adverse effects during and after dosing till endpoint date
Female	219103186-08-00-F1	223.8	0.45	2000	No adverse effects observed
	219103186-08-00-F2	216.6	0.43	2000	No adverse effects observed
	219103186-08-00-F3	226.7	0.45	2000	No adverse effects observed
	219103186-08-00-F4	199.7	0.40	2000	No adverse effects observed
	219103186-08-00-F5	188.8	0.38	2000	No adverse effects observed

 

Group No	Animal ID	Body weight (g)	Amount of test item used for dosing (g)	Dose level (based on weight of the test item, mg/kg) by body weight	Adverse effects during and after dosing till endpoint date
Male	219103186-08-00-M1	321.1	0.64	2000	No adverse effects observed
	219103186-08-00-M2	332.2	0.66	2000	No adverse effects observed
	219103186-08-00-M3	382.9	0.77	2000	No adverse effects observed
	219103186-08-00-M4	294.2	0.59	2000	No adverse effects observed
	219103186-08-00-M5	313.3	0.63	2000	No adverse effects observed

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

After an application period of 14 days followed by an observation period of 14 days, no mortality and other adverse effects were observed. Strontium ferrite is non-toxic via the dermal route according to CLP.

Executive summary:

The acute dermal toxicity of strontium ferrite was assessed in a limit test according to OECD 402 and UN-GHS. 2000 mg/kg bw of the test item was applied on the skin of Wistar-rats. The exposure period was 24 hours followed by an observation period of 14 days. No mortalities or other adverse effects were observed. It can therefore be concluded that the dermal LD50 is above the tested concentration of 2000 mg/kg bw.