Prussian blue

Skin irritation / corrosion

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:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

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

Test guideline 2

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

Test guideline 3

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

Test material information

Constituent 1

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

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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