Registration Dossier

Administrative data

Description of key information

Acute oral and dermal toxicity studies are available, performed similar to or according to OECD test guidelines respectively for the target's analogue sodium ferrocyanide. The LD50 values are > 2000 mg/kg bw for both studies.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
In all animals diarrhoea was observed on the first day (day 1) after application.
Body weight:
No data.
Gross pathology:
No data
Other findings:
None.
Interpretation of results:
other: Not classified according to Regulation EC 1272/2008
Conclusions:
In an acute oral toxicity study with male and female rats, performed equivalent or similar to OECD 401 guideline, the LD50 was calculated to be >5110 mg/kg. This result can be read across to potassium ferrocyanide.
Executive summary:

In an acute oral toxicity study, performed comparable to OECD test guideline 401, male and female rats were exposed to 5110 mg/kg via gavage. No deaths occurred during the study. In all animals diarrhoea was observed on the first day (day 1) after application. The LD50 was determined to be >5110 mg/kg.

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 110 mg/kg bw
Quality of whole database:
The study has been performed equivalent or similar to OECD 401 guideline. The report contains limited information about substance identity and was not conducted according to GLP principles.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female was found dead on day 2 of treatment.
Clinical signs:
Chromodacryorrhoea and/or piloerection were noted in the majority of animals between days 1 and 3. Hunched posture was seen in one male on Day 1 and flat posture was seen in one male on day 1.
The animal found dead showed hunched posture, piloerection, chromodacryorrhoea and ptosis on day 1.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
Gross pathology:
Macroscopic post mortem examination of the animal that died during the study and of the animals surviving to the end of the study did not reveal any abnormalities.
Pelvic dilation of the kidneys (one male), is commonly noted among rats of this age and strain and were therefore considered not toxicologically significant.
Other findings:
Scales were seen in the treated skin-area of one animal during the observation period.
Interpretation of results:
other: Not classified according to Regulation (EC) 1272/2008
Conclusions:
In an acute dermal toxicity study with rats, performed according to OECD/EC test guideline, an LD50 >2000 mg/kg bw was determined. This result can be read across to potassium ferrocyanide.
Executive summary:

An acute dermal toxicity test was performed according to OECD/EC guideline and GLP principles. Five male and five female rats were exposed to 2000 mg/kg bw for 24 hours. One female was found dead on day 2, this animal showed hunched posture, piloerection, chromodacryorrhoea and ptosis on day 1. In the majority of the other rats, clinical signs such as chromodacryorrhoea and/or piloerection were noted between days 1 and 3. Hunched posture was seen in one male on day 1 and flat posture was seen in one male on day 1. No changes in body weight gain were noted, no abnormalities were found after nacroscopical examination. Scales were seen in the treated skin-area of one animal during the observation period.

Based on these data, the test substance is not classified for acute dermal toxicity.

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Additional information

In an acute oral toxicity study, performed with the read across substance sodium ferrocyanide and comparable to OECD test guideline 401, male and female rats were exposed to 5110 mg/kg via gavage. No deaths occurred during the study. In all animals diarrhoea was observed on the first day (day 1) after application. The LD50 was determined to be >5110 mg/kg.

An acute dermal toxicity test was performed with the read across substance sodium ferrocyanide and according to OECD/EC guideline and GLP principles. Five male and five female rats were exposed to 2000 mg/kg bw for 24 hours. One female was found dead on day 2, this animal showed hunched posture, piloerection, chromodacryorrhoea and ptosis on day 1. In the majority of the other rats, clinical signs such as chromodacryorrhoea and/or piloerection were noted between days 1 and 3. Hunched posture was seen in one male on day 1 and flat posture was seen in one male on day 1. No changes in body weight gain were noted, no abnormalities were found after nacroscopical examination. Scales were seen in the treated skin-area of one animal during the observation period.


Justification for selection of acute toxicity – oral endpoint
One study is available with Klimisch reliability 2.

Justification for selection of acute toxicity – dermal endpoint
One study is available with Klimisch reliability 1.

Justification for classification or non-classification

Based on the available studies of the target's analogue sodium ferrocyanide, potassium ferrocyanide is not classified for acute toxicity according to the CLP Regulation (No) EC 1272/2008.