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EC number: 237-875-5 | CAS number: 14038-43-8
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Aug 2010 - 29 Apr 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- yes
- Remarks:
- an occlusive dressing was used
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- yes
- Remarks:
- an occlusive dressing was used
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- adopted in 1998
- Deviations:
- yes
- Remarks:
- an occlusive dressing was used
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Országos Gyógyszerészeti Intézet, National Institute of Pharmacy, Budapest, Hungary
Test material
- Reference substance name:
- Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)
- EC Number:
- 247-304-1
- EC Name:
- Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)
- Cas Number:
- 25869-00-5
- Molecular formula:
- C6FeN6H4N
- IUPAC Name:
- Ammonium Iron(3+) Hexakis(Cyano-C)Ferrate(4-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): ammonium iron(3+) hexakis(cyano-C) ferrate(4-)
- Physical state: solid
- Appearance: blue odourless powder
- Analytical purity: 93.6%
- Lot/batch No.: K73-4766
- Expiration date of the lot/batch: 20 Mar 2013
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft., Kartal, Hungary
- Age at study initiation: approximately 11 weeks
- Weight at study initiation: 2792 - 2888 g
- Housing: The animals were housed individually in metal wire rabbit cages (65x65x45 cm).
- Diet: Purina Base - Lap gr. diet for rabbits, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 22.1
- Humidity (%): 53 - 81
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 17 Aug 2010
To: 20 Aug 2010
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Not required, the untreated skin of each animal served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on back and flanks
- Type of wrap if used: The treated skin was covered with 4 layers of fine medical gauze (open-weave with large holes), held in place with a patch of clear plastic with a surrounding adhesive hypoallergenic plaster. Additionally, the entire trunk of each animal was wrapped with plastic wrap held in place with medical elastic tubing.
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed with water at body temperature.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- The dermal application of the test substance resulted in very slight erythema and edema formation (score 1) in one animal at the 1 and 24 h reading time point. The effect reversed within 48 h. No effect on another animal was observed at any time point.
- Other effects:
- No mortality occurred during the study period. No clinical signs or adverse effects on body weight were observed at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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