Registration Dossier
Registration Dossier
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EC number: 234-685-4 | CAS number: 12023-91-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-05-03 to 2010-07-30
- 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
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- In addition: Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Second revised edition, 2007. Chapter 3.2 Skin corrosion / irritation
- Deviations:
- no
- 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 romm temperature, non-sterile
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- 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: young adults
- Weight at study initiation:
- Housing: Conventional rabbit cage system
- Diet (e.g. ad libitum): Haraln Teklad Globle High Fiber Rabbit Diet 2931
- Water (e.g. ad libitum): tap
- Acclimation period: at least 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:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5g of the test substance was loaded on a gauze patch (approximately 6 cm2) and moistened with 300µl of water for injection.
- Duration of treatment / exposure:
- 4 h exposure
- Observation period:
- 0 h (immediately, 1 h, 24 h, 48 h, 72 h after patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage:
- Type of wrap if used: dressing and surgical tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using water and mild soap
- Time after start of exposure: 4 h
SCORING SYSTEM:
Dermal reactions of application site in each animal were graded according to the grades in the table below:
Reaction Score
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet-redness) to eschar formation preventing grading of erythema 4
(Maximum possible)
4
Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Well- defined oedema (edges of area well- defined by definite raising) 2
Moderate oedema (raising approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond exposure area) 4
(Maximum possible)
4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- erythema and eschar format
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- erythema and eschar format
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- erythema score
- Remarks:
- erythema and eschar format
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Other effects:
- No other adverse effect was observed on all test animals during 72-hr observation period.
Any other information on results incl. tables
Grades of erythema and eschar formation
Animal ID |
0hr |
1hr |
24hrs |
48hrs |
72hrs |
Mean value of grading at 24, 48 and 72hrs |
219103186-04-00-1 |
0 |
0 |
0 |
0 |
0 |
0 |
219103186-04-00-2 |
1 |
1 |
1 |
0 |
0 |
0.3 |
219103186-04-00-3 |
0 |
0 |
0 |
0 |
0 |
0 |
Grades of Edema formation
Animal ID |
0hr |
1hr |
24hrs |
48hrs |
72hrs |
Mean value of grading at 24, 48 and 72hrs |
219103186-04-00-1 |
0 |
0 |
0 |
0 |
0 |
0 |
219103186-04-00-2 |
0 |
0 |
0 |
0 |
0 |
0 |
219103186-04-00-3 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the above results and GHS, strontium ferrite is not classified as irritant.
- Executive summary:
The acute dermal irritation of strontium ferrite was assessed in a test according to OECD 404 and UN-GHS. No animal showed mean value ≥2.3 for erythema / eschar or for oedema. One animal showed barely perceptible erythema shortly after application which was fully reversible. No other effects were observed.
Based on the results, strontium ferrite can be considered as not irritant to skin and does not require labelling.
In-vitro testing for skin corrosion and skin irritation is not required.
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