Registration Dossier

Administrative data

Description of key information

Both for skin and eye, in vivo irritation studies are available, which have been performed according to OECD test guidelines for the target's analogue sodium ferrocyanide. In these studies, the substance did not show significant irritation in either eye or skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Based on identical metal-cyanide complex species, the source substance sodium ferrocyanide and the target substance potassium ferrocyanide can be regarded as analogues, which implies that data from sodium ferrocyanide can be read-across to the target substance potassium ferrocyanide based on this information. The complete rationale can be found in the read-across report in section 13.
Reason / purpose:
read-across source
Reason / purpose:
assessment report
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The test substance caused no erythema and no edema at any time point on the intact skin test sites.
Other effects:
No signs of systemic intoxication were observed during the study period.
Interpretation of results:
other: Not classified according to Regulation (EC) 1272/2008
Conclusions:
In a skin irritation study with rabbits, performed equivalent or similar to OECD 404 guideline, no irritation was observed. This result can be read across to potassium ferrocyanide.
Executive summary:

In a skin irritation study performed according to OECD test guideline 404, the substance (0.5 g) was applied onto the shaved skin of three rabbits using occlusive dressings for 4 hours. Under the conditions of this study, no irritation was observed for 72 hours. The test substance caused no erythema and no edema on the intact skin test sites. No signs of systemic intoxication were observed during the study period.

The result can be read across to the target substance, potassium ferrocyanide.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Based on identical metal-cyanide complex species, the source substance sodium ferrocyanide and the target substance potassium ferrocyanide can be regarded as analogues, which implies that data from sodium ferrocyanide can be read-across to the target substance potassium ferrocyanide based on this information. The complete rationale can be found in the read-across report in section 13.
Reason / purpose:
read-across source
Reason / purpose:
assessment report
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
In animal #1 a conjuctivae score (redness) grade 1 was observed. This observation was fully reversible within 72 hours.
Other effects:
No signs of systemic intoxication were observed during the study period.
Interpretation of results:
other: Not classified according to Regulation (EC) 1272/2008
Conclusions:
In an eye irritation study with rabbits, performed equivalent or similar to OECD 405 guideline, no significant irritation was observed. This result can be read across to potassium ferrocyanide.
Executive summary:

In an eye irritation study performed according to OECD test guideline 405, one eye of each of three rabbits was treated with 0.1 g sodium ferrocyanide. In one animal a conjuctivae score (redness) grade 1 was observed. This observation was fully reversible within 72 hours. No further irritation was observed in any of the animals treated. No signs of systemic intoxication were observed during the study period.

The results can be read across to the target substance, potassium ferrocyanide.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a skin irritation study performed with the read across substance sodium ferrocyanide and according to OECD test guideline 404, the (moistened) substance (0.5 g) was applied onto the shaved skin of three rabbits using occlusive dressings for 4 hours. Under the conditions of this study, no irritation was observed for 72 hours. The test substance caused no erythema and no edema on the intact skin test sites. No signs of systemic intoxication were observed during the study period.

In an eye irritation study performed according to OECD test guideline 405, one eye of each of three rabbits was treated with 0.1 g of the read across substance sodium ferrocyanide. In one animal a conjuctivae score (redness) grade 1 was observed. This observation was fully reversible within 72 hours. No further irritation was observed in any of the animals treated. No signs of systemic intoxication were observed during the study period.


Justification for selection of skin irritation / corrosion endpoint:
One study available with Klimisch reliability 2. The study has been performed equivalent or similar to OECD 404 guideline. Study has however limited information about substance identity and was not performed according to GLP guidelines.

Justification for selection of eye irritation endpoint:
One study available with Klimisch reliability 2. The study has been performed equivalent or similar to OECD 405 guideline. Study has however limited information about substance identity and was not performed according to GLP guidelines.

Justification for classification or non-classification

According to the available data, the target's analogue sodium ferrocyanide was not irritating to either eye or skin. Therefore potassium ferrocyanide does not have to be classified for skin and eye irritation according to CLP Regulation (EC) No. 1272/2008.