Prussian blue

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 Sep 2010 - 06 May 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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

adopted in 2002

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

adopted in 1998

Deviations:

yes

Remarks:

The eyes were washed after 1 h instead of 24 h after instillation of the test substance.

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 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
- pH value: 6.0

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: S&K-LAP Kft., Kartal, Hungary
- Age at study initiation: 15 weeks
- Weight at study initiation: 3466 - 3895 g
- Housing: The animals were housed individually in metal wire rabbit cages.
- Diet: PURINA Base – Lap gr. diet for rabbits, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 29 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 54 - 86
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 16 Sep 2010
To: 19 Sep 2010

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Not required, the untreated eye served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:

1 h

Observation period (in vivo):

72 h
reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline solution
- Time after start of exposure: 1 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Very slight conjunctivae redness (score 1) was found in all animals at the 1 h reading time point. After 24 h, very slight conjunctivae redness was still observed in 2/3 animals. The effect was reversible in all animals within 48 h. Very slight chemosis (score 1) was observed in 1/3 animals at the 1 h reading time point and was reversible within 24 h. Very slight corneal opacity (score 1) was noted in 2/3 animals after 1 h. The opacity resolved in all animals within 24 h. No effect on the iris of any 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