Registration Dossier

Administrative data

Description of key information

Skin irritation:

Prussian blue was used as test material to evaluate skin irritation potential on rabbit. Prussian blue when subjected as acute exposure to the skin of rabbit produced no skin irritation reactions. Hence , Prussian blue was considered to be not irritating on rabbit skin.

 Based on this exprimental result; Prussian blue can be considered not irritating to skin and can be classified under the category “Not classified” as per CLP regulation.

Eye irritation:

The eye irritation potential of Prussian blue was assessed in rabbits.The test chemical was introduced into the eyes by tattooing into the corneas of rabbits. Tattooing the corneas of rabbits with Prussian Blue led to permanent coloration of the corneas, but did not cause any irritation.

Hence,Prussian Blue can be considered to be not irritating to rabbit eyes.

 Based on this exprimental result; Prussian blue can be considered not irritating to eye and can be classified under the category “Not classified” as per CLP regulation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authorative database.
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate skin irritation potential of Prussian blue rabbit skin.
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: Prussian blue
- IUPAC name: iron(2+);iron(3+);octadecacyanide
- Common name: C.I. Pigment Blue 27
- Molecular formula: C6FeN6.4/3Fe
- Molecular weight: 859.23 g/mol
- Smiles : [CH-](#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[CH-](#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[CH-] (#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[Fe+3].[Fe+3].[Fe+3].[Fe+3]
- InChI : 1S/18CN.7Fe/c18*1-2;;;;;;;/q18*-1;3*+2;4*+3
- Substance type: Inorganic
- Physical state: Solid powder (dark blue)
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No data available
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified
Duration of treatment / exposure:
Not specified
Observation period:
Not specified
Number of animals:
Not specified
Details on study design:
Not specified
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Not specified
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin irritation reaction was observed
Interpretation of results:
other: Not classified
Conclusions:
Prussian blue when subjected as acute exposure to the skin of rabbit produced no skin irritation reactions. Hence , Prussian blue was considered to be not irritating on rabbit skin.
Executive summary:

Prussian blue was used as test material to evaluate skin irritation potential on rabbit. Prussian blue when subjected as acute exposure to the skin of rabbit produced no skin irritation reactions. Hence , Prussian blue was considered to be not irritating on rabbit skin.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from reliable handbooks
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the eye irritation potential of Prussian blue in rabbits
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: Prussian blue
- IUPAC name: iron(2+);iron(3+);octadecacyanide
- Common name: C.I. Pigment Blue 27
- Molecular formula: C6FeN6.4/3Fe
- Molecular weight: 859.23 g/mol
- Smiles : [CH-](#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[CH-](#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[CH-] (#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[Fe+3].[Fe+3].[Fe+3].[Fe+3]
- InChI : 1S/18CN.7Fe/c18*1-2;;;;;;;/q18*-1;3*+2;4*+3
- Substance type: Inorganic
- Physical state: Solid powder (dark blue)
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
no data available
Duration of treatment / exposure:
no data available
Observation period (in vivo):
no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Details on study design:
no data available
Other effects / acceptance of results:
no data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Permanent coloration of the cornea was observed, but no signs of irritation.
Interpretation of results:
other: not irritating
Conclusions:
Tattooing the corneas of rabbits with Prussian Blue led to permanent coloration of the corneas, but did not cause any irritation.
Hence, Prussian Blue can be considered to be not irritating to rabbit eyes.
Executive summary:

The eye irritation potential of Prussian blue was assessed in rabbits.The test chemical was introduced into the eyes by tattooing into the corneas of rabbits. Tattooing the corneas of rabbits with Prussian Blue led topermanent coloration of the corneas, but did not cause any irritation.

Hence,Prussian Blue can be considered to be not irritating to rabbit eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

Various studies were summarized to determine the amount of dermal irritation caused by Prussian blue[CAS: 14038 -43 -8] in living organisms.The studies are based on in vivo experiments in rabbits along with for target chemical and its similar read across chemicals,Turnbull's blue[CAS: 25869-98-1] and Sodium ferrocyanide [CAS:13601-19-9].The results are summarized as follows:

Prussian blue was used as test material to evaluate (Hazardous Substance Databank [HSDB], U.S National Library of Medicine, last updated 2012) skin irritation potential on rabbit. Prussian blue when subjected as acute exposure to the skin of rabbit produced no skin irritation reactions. Hence, Prussian blue was considered to be not irritating on rabbit skin.

This result is supported by the experimental study summarized in IUCLID Dataset, EUROPEAN COMMISSION – European Chemicals Bureau, 2000; for thesimilar read across chemical,Turnbull's blue[CAS: 25869-98-1].The test was performed according to OECD 404 Guidelines. Turnbull's blue was applied to the skin of rabbits and observed for signs of dermal irritation (dose, duration and observation period not mentioned). Turnbull's blue did not cause any dermal reactions to rabbit skin.

Hence, Turnbull's blue can be considered to be not irritating to skin.

The above results are further supported by the experimental study summarized in IUCLID Dataset - Tetrasodium Hexacyanoferrate, European Chemicals Bureau (ECB), 2000; for the similar read across chemical, Sodium ferrocyanide [CAS:13601-19-9]. The test was performed according to OECD 404 Guidelines. Sodium ferrocyanide was applied to the skin of rabbits and observed for signs of dermal irritation (dose, duration and observation period not mentioned). Sodium ferrocyanide did not cause any dermal reactions to rabbit skin.

Hence, Sodium ferrocyanide can be considered to be not irritating to skin.

Based on the available data for the target substanceas well as similar read across chemicals and applying the weight of evidence approach, Ferric Ferrocyanide[CAS: 14038 -43 -8] can be considered to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.

Eye Irritation:

In different studies,Prussian Blue[CAS: 14038 -43 -8] has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits and humans for the target chemical.

The eye irritation potential of Prussian blue was assessed in rabbits and humans and the results were summarized by W. Morton Grant et.al (Toxicology of the Eye: Effects on the Eyes and Visual System from Chemicals, Drugs, Metals and Mineral, Plants, Toxins and Venoms: Also, Systemic Side Effects from Eye Medications, pg 1216, 4th Edition,1993).

In rabbits, Prussian Blue was introduced into the eyes by tattooing into the corneas of rabbits, whereas in humans, it was introduced into the eyes by tattooing into the scarred corneas of humans. Tattooing the corneas of rabbits and humans with Prussian Blue led to permanent coloration of the corneas, but did not cause any irritation.

Hence, Prussian Blue can be considered to be not irritating to rabbit and human eyes.

These results are further supported by the study summarized in Hazardous Substance Databank [HSDB], U.S National Library of Medicine, last updated 2012, for assessing the degree of irritation caused by Prussian Blue in rabbits. Prussian blue was instilled in to the eyes of rabbits and observed for effects (dose, duration and observation period not mentioned). Prussian blue did not cause any irritation or reaction to the rabbit eyes.

Hence, Prussian blue can be considered to be not irritating to eyes.

The results from above studies indicate a very strong possibility that Prussian Blue is indeed not irritating to eyes.

Applying the weight of evidence approach, Prussian Blue[CAS: 14038- 43 -8] can be considered to be not irritating to eyes.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.

Justification for classification or non-classification

Based on the available data for the target,it can be concluded that Prussian blue was not irritating to skin and eye; and it can be classified under the category “Not Classified” as per CLP regulation.