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Administrative data

Description of key information

Acute Oral Toxicity: 

In Acute oral toxicity, LD50 value for target substance Prussian blue(14068-43-8) was considered to be >8000 mg/kg bw for rats ; >8000 mg/kg bw for mouse and >8000 mg/kg bw for rabbits. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Prussian blue(14068-43-8) cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity: 

The melting point of C.I.Pigment Blue 27 is >300 C. This suggests that Prussian blue insoluble decomposes between 210°C -360 °C without melting and does not exhibit very high vapour pressure. Inhalation is therefore not likely route of exposure and hence this end point is considered for waiver.

Acute Dermal Toxicity:

The Prussian blue insoluble (14038-43-8) has high molecular weight i.e 877.381g/mole. This suggests that Prussian blue insoluble has no potential for significant rate of absorption through skin and hence this end point is considered for waiver.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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 authoritative database
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of Prussian blue(14068-43-8) was performed in Rat
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material: Prussian blue
- IUPAC name: C.I.Pigment Blue 27
- Molecular formula: C6FeN6.4/3Fe
- Molecular weight (if other than submission substance): 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:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
8000 mg/kg bw
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed at dose 8000 mg/kg bw
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: Not classified
Conclusions:
the LD50 value was considered to be >8000 mg/kg body weight,when rats was treated with Prussian blue (14038-43-8) orally.
Executive summary:

Acute oral toxicity study was done in rats using Prussian blue (14038-43-8).No mortality was observed at dose 8000mg/kg bw.Hence LD50 was considered to be >8000mg/kgbody weight,when rats were treated with Prussian blue (14038-43-8)orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
8 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from authoritative database

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Quality of whole database:
Waiver

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Endpoint conclusion
Quality of whole database:
Waiver

Additional information

Acute Oral Toxicity: 

In different studies, Prussian blue insoluble (14038-43-8) has been investigated for acute oral toxicity to a greater or lesser extent. Often the studies are based on in vivo experiments data in rodents, i.e. most commonly in rats for Prussian blue insoluble (14038-43-8). The different studies on target substance are summarized as below –

In another experimental study conducted by U.S. National Library of Medicine (Chemidplus Database,U.S. National Library of Medicine,2017) for the target substance Prussian blue insoluble (14038-43-8). Acute oral toxicity study was done in rats using Prussian blue (14038-43-8).No mortality was observed at dose 8000mg/kg bw.Hence LD50 was considered to be >8000 mg/kg body weight,when rats were treated with Prussian blue (14038-43-8)orally.

Also these results are further supported by the experimental study conducted by U.S. National Library of Medicine (Chemidplus Database,U.S. National Library of Medicine,2017) for the target substance Prussian blue insoluble (14038-43-8). Acute oral toxicity study was done in mouse using Prussian blue (14038-43-8).No mortality was observed at dose 8000 mg/kg bw.Hence LD50 was considered to be >8000mg/kg body weight,when mouse was treated with Prussian blue (14038-43-8)orally.

This is further supported by U.S. National Library of Medicine (Chemidplus Database,U.S. National Library of Medicine,2017) for the target substance Prussian blue insoluble (14038-43-8). Acute oral toxicity study was done in rabbit using Prussian blue (14038-43-8).No mortality was observed at dose 8000 mg/kg bw.Hence LD50 was considered to be >8000 mg/kg body weight,when rabbit was treated with Prussian blue (14038-43-8)orally.

Thus, based on the above different studies on Prussian blue insoluble (14038-43-8), it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Prussian blue insoluble (14038-43-8)cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity: 

The melting point of C.I.Pigment Blue 27 is >300 C. This suggests that Prussian blue insoluble decomposes between 210°C -360 °C without melting and does not exhibit very high vapour pressure. Inhalation is therefore not likely route of exposure and hence this end point is considered for waiver.

Acute Dermal Toxicity:

The Prussian blue insoluble (14038-43-8) has high molecular weight i.e 877.381g/mole. This suggests that Prussian blue insoluble has no potential for significant rate of absorption through skin and hence this end point is considered for waiver.

Justification for classification or non-classification

Based on the above experimental studies on Prussian blue insoluble (14038-43-8), it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Prussian blue insoluble (14038-43-8) cannot be classified for acute oral toxicity. For Acute dermal and acute inhalation toxicity wavier was added so, not possible to classify.