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EC number: 234-685-4 | CAS number: 12023-91-5
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-08-03 to 2010-09-20
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- yes
- Remarks:
- One staff member was not included in the study plan. Deviation has no impact on the validity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- 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
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- 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: 7 - 9 weeks
- Weight at study initiation:268 - 306 g
- Fasting period before study: n.d.
- Housing: OptiMICE Caging Systems
- Individual metabolism cages: yes/no
- Diet (e.g. ad libitum): LabDiet 5053-PicoLab Rodent Diet 20 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 30 - 70
- Air changes (per hr): n.d.
- Photoperiod (hrs dark / hrs light): n.d.
IN-LIFE DATES: From: To: n.d.
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: > 10 %
- Type of wrap if used: gauze patch
- Time intervals for shavings or clipplings: shaving 24 h before test
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing by mild soap and tap water
- Time after start of exposure: 6 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.54 - 0.62 g, adjusted to body weight
- concentration (if solution): test substance was moistened with 0.5 - 1.0 ml water
VEHICLE
- Justification for use and choice of vehicle (if other than water): not applicable
- Amount(s) applied (volume or weight with unit): 0.5 - 1.0 ml water
- Concentration (if solution): not applicable
- Lot/batch no. (if required): S16/179/08
- Purity: ca. 100 %
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Duration and frequency of treatment / exposure:
- Duration: up to 6 h
Frequency of exposure: 1
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.54 - 0.62 g, adjusted to body weight, in 0.5 - 1.0 ml water.
Dose level: 2000 mg/kg bw and 5000 mg/kg bw
- No. of animals per sex per dose / concentration:
- 20
- Control animals:
- no
- Details on study design:
- - Dose selection rationale: high doses due to expexted non-toxicity
- Rationale for animal assignment (if not random): - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): blood
- Time and frequency of sampling: After 30 min, 2 h, 6 h, 10 h and 24 h (frequency:5)
- Other:
Results and discussion
Any other information on results incl. tables
Dose level: 2000mg/kg body weight
Animal ID |
Body weight (g) |
Amount of test substance applied (g) |
Date |
Time-Patch on |
Time-Patch off |
Time-Blood collection |
219103186-10-00-30min-1 |
300.3 |
0.60 |
05/08/2010 |
10:15 |
10:45 |
10:50 |
219103186-10-00-30min-2 |
293.3 |
0.59 |
10:20 |
10:50 |
10:55 |
|
219103186-10-00-30min-3 |
280.9 |
0.56 |
10:25 |
10:55 |
11:05 |
|
219103186-10-00-30min-4 |
287.9 |
0.58 |
10:30 |
11:00 |
11.14 |
|
219103186-10-00-2h-1 |
290.8 |
0.58 |
05/08/2010 |
8:50 |
10:50 |
11:00 |
219103186-10-00-2h-2 |
300.7 |
0.60 |
8:55 |
10:55 |
11:05 |
|
219103186-10-00-2h-3 |
284.5 |
0.57 |
9:05 |
11:05 |
11:14 |
|
219103186-10-00-2h-4 |
297.3 |
0.59 |
9:10 |
11:10 |
11:20 |
|
219103186-10-00-6h-1 |
297.3 |
0.59 |
04/08/2010 |
9:10 |
15:10 |
15:17 |
219103186-10-00-6h-2 |
306.4 |
0.61 |
9:20 |
15:20 |
15:27 |
|
219103186-10-00-6h-3 |
312.1 |
0.62 |
9:25 |
15:25 |
15:37 |
|
219103186-10-00-6h-4 |
272.4 |
0.54 |
9:33 |
15:33 |
15:45 |
|
219103186-10-00-10h-1 |
275.5 |
0.55 |
04/08/2010 |
8:35 |
14:35 |
18:40 |
219103186-10-00-10h-2 |
288.8 |
0.58 |
8:45 |
14:45 |
18:52 |
|
219103186-10-00-10h-3 |
268.1 |
0.54 |
8:50 |
14:50 |
19:00 |
|
219103186-10-00-10h-4 |
275.3 |
0.55 |
9:00 |
15:00 |
19:10 |
|
219103186-10-00-24h-1 |
292.0 |
0.58 |
04/08/2010 |
9:40 |
15:40 |
9:45 on 05/08/10 |
219103186-10-00-24h-2 |
285.4 |
0.57 |
9:45 |
15:45 |
9:55 on 05/08/10 |
|
219103186-10-00-24h-3 |
299.5 |
0.60 |
9:52 |
15:52 |
10:05 on 05/08/10 |
|
219103186-10-00-24h-4 |
282.8 |
0.57 |
10:00 |
16:00 |
10:00 on 05/08/10 |
Dose level: 5000mg/kg body weight
Animal ID |
Body weight (g) |
Amount of test substance applied (g) |
Date |
Time-Patch on |
Time-Patch off |
Time-Blood collection |
219103186-10-00-5000mg-30min-1 |
278.2 |
1.39 |
12/08/2010 |
14:55 |
15:25 |
15:32 |
219103186-10-00-5000mg-30min-2 |
282.2 |
1.41 |
15:00 |
15:30 |
15:40 |
|
219103186-10-00-5000mg-30min-3 |
273.3 |
1.37 |
15:02 |
15:32 |
15:48 |
|
219103186-10-00-5000mg-30min-4 |
254.6 |
1.27 |
15:05 |
15:35 |
15:55 |
|
219103186-10-00-5000mg-2h-1 |
298.4 |
1.49 |
12/08/2010 |
14:35 |
16:35 |
16:39 |
219103186-10-00-5000mg-2h-2 |
267.1 |
1.34 |
14:40 |
16:40 |
16:46 |
|
219103186-10-00-5000mg-2h-3 |
293.1 |
1.47 |
14:45 |
16:45 |
16:52 |
|
219103186-10-00-5000mg-2h-4 |
286.3 |
1.43 |
14:50 |
16:50 |
17:00 |
|
219103186-10-00-5000mg-6h-1 |
246.8 |
1.23 |
11/08/2010 |
9:05 |
15:05 |
15:10 |
219103186-10-00-5000mg-6h-2 |
256.4 |
1.28 |
9:10 |
15:10 |
15:20 |
|
219103186-10-00-5000mg-6h-3 |
276.2 |
1.38 |
9:15 |
15:15 |
15:25 |
|
219103186-10-00-5000mg-6h-4 |
233.4 |
1.17 |
9:20 |
15:20 |
15:35 |
|
219103186-10-00-5000mg-10h-1 |
246.5 |
1.23 |
11/08/2010 |
8:40 |
14:40 |
18:45 |
219103186-10-00-5000mg-10h-2 |
274.0 |
1.37 |
8:50 |
14:50 |
18:55 |
|
219103186-10-00-5000mg-10h-3 |
265.4 |
1.33 |
8:55 |
14:55 |
19:05 |
|
219103186-10-00-5000mg-10h-4 |
252.8 |
1.26 |
9:00 |
15:00 |
19:10 |
|
219103186-10-00-5000mg-24h-1 |
273.0 |
1.37 |
11/08/2010 |
9:25 |
15:25 |
9:29 on 12/08/10 |
219103186-10-00-5000mg-24h-2 |
226.9 |
1.13 |
9:30 |
15:30 |
9:36 on 12/08/10 |
|
219103186-10-00-5000mg-24h-3 |
272.3 |
1.36 |
9:35 |
15:35 |
10:43 on 12/08/10 |
|
219103186-10-00-5000mg-24h-4 |
253.8 |
1.27 |
9:40 |
15:40 |
9:50 on 12/08/10 |
Blood concentration of strontium ferrite in each animal was below detection level (method: ICP-MS) at any sampling intervall with both doses.
No other adverse effect was observed on all test animals during the study.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
The test substance was not detectable at all time points at both dose levels.
Based on the above results, strontium ferrite was not detected in the blood after dermal route application. There was no significant absorption through dermal application. - Executive summary:
A toxicokinetic study according to OECD 417 was performed by using Wistar rats. 2000 mg/kg b.w. and 5000 mg/kg b.w. of the test substance strontium ferrite was applied to 20 animals each via the dermal route. Blood samples were taken 30 min, 2 h, 6 h, 10 h and 24 after the application period of 6 h. Blood concentration of strontium ferrite in each animal was below detection level (method: ICP-MS) at any sampling intervall with both doses.
The test substance was not detectable at all time points at both dose levels. Based on the above results, strontium ferrite was not detected in the blood after dermal route application. There was no significant absorption through dermal application. No other adverse effect was observed on all test animals during the study.
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