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EC number: 234-426-5 | CAS number: 12003-38-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jul 11 - Oct 31, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD TG 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fluorphlogopite (Mg3K[AlF2O(SiO3)3])
- EC Number:
- 234-426-5
- EC Name:
- Fluorphlogopite (Mg3K[AlF2O(SiO3)3])
- Cas Number:
- 12003-38-2
- Molecular formula:
- AlF2O10Si33Mg
- IUPAC Name:
- Fluorphlogopite
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kil3legg
- Age at study initiation: 12 - 13 weeks
- Weight at study initiation: 3 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 48 - 78 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: aqua pro injectione
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- after 24, 48, 72 hours and then up to day 8
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm^2
- % coverage: 100 %
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 hours
SCORING SYSTEM:
according to Draize, OECD and EC recommendations
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72, day 5, day 6, day 7, day 8
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72, day 5, day 6, day 7, day 8
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The scores from all animals were "0" at all time points investigated.
- Other effects:
- All animals survived the observation period.
The body weight development of the treated rabbits was inconspicuous.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No skin irritating potential could be detected. According to OECD GHS, the test material should not be classified as a skin irritant.
- Executive summary:
Summary
Study design
The study was performed according to the OECD Guideline for Testing of Chemicals, No. 404, the annex to Directive 92/69 EEC, and the recommendations of DRAIZE (1959).
To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 7 days.
Results
Under the conditions of the present study no signs of irritation were seen.
Evaluation of all animals (mean score)
Day (after treatment) 1
(1 hour)2
(24 hours)3
(48 hours)4
(72 hours)Erythema 0 0 0 0 Edema 0 0 0 0
Evaluation of each animal
Mean Score
(24, 48, 72 hours)Max Score
(24, 48, 72 hours)Animal No. 15 19 21 15 19 21 Erythema 0 0 0 0 0 0 Edema 0 0 0 0 0 0
Conclusions
No skin irritating potential could be detected. According to OECD GHS, the test material should not be classified as a skin irritant.
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