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EC number: 237-323-3 | CAS number: 13746-66-2
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Carcinogenicity
Administrative data
Description of key information
In a long term (two year) repeated dose toxicity study with sodium ferrocyanide in rats, the NOAEL was determined to be ≥ 630 and ≥ 450 mg/kg bw/day for females and males, respectively, based on the absence of effects seen at the highest concentration (5000 ppm in the food). This result is read across to potassium ferricyanide (the read across hypothesis is attached in section 13).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: 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 presence of identical metal-cyanide complex species, sodium ferrocyanide and potassium ferricyanide can be regarded as analogues, which implies that data from sodium ferrocyanide can be read across to tpotassium ferricyanide. The read across hypothesis is attached in 'Attached justification'.
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Description (incidence):
- Findings were generally similar in both the control and treated groups. The percentage mortality of the control rats for both sexes was higher than that of the three treatment groups at the end of the study.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weight of male and female rats in the control and treatment groups were similar throughout the course of the 2-y study. Female rats given 5000 ppm had a slightly lower mean body weight compared to control rats during the latter of the study, resulting in statistically significance during some weeks, 41-49 and 57-61 and week 92, but the weights were all within 7% of the control values for these periods. This is not considered to be toxicologically relevant.
Interim I and II study: Comparable trends. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption differed during the study, sometimes being less compared to controls, sometimes being more compared to controls. In some weeks this was statistically significant, but these differences were not considered to be related to treatment.
Interim I and II study: comparable trends.
The calculated intake (mg/kg bw/d) over the whole study period expressed for m/f:
2-y study; Interim I; Interim II;
50 ppm 4.4/6.2; 5.4/6.8; 4.7/6.8
500 ppm 45.0/62.5; 51.8/69.8; 46.8/63.8
5000 ppm 450.7/630.1; 519.5/692.5; 461.8/672.5 - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- The pattern of water consumption by male and female rats in the control and 50 and 500 ppm treatment groups was similar throughout the study. Male and female rats administered 5000 ppm drank more than control animals during the first nine months of the study. During the last year of the study water quantities were comparable between 5000 ppm group and controls. While the difference seen in the first year of the study must be attributed to treatment with sodium ferrocyanide there is no indication that this is an adverse effect (see also Urinalysis results).
Interim I and II study: Comparable trends, however, the high water intakes seen in rats given 5000 ppm substance during the earlier part of the 2-y study were not repeated in the corresponding periods of the interim studies. - Ophthalmological findings:
- not examined
- Description (incidence and severity):
- not required
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Changes observed in treated animals were not dose-related or common to both sexes on any single occasion, and were not found consistently on different occasions. Therefore none of the effects seen are considered to be a consequence of treatment.
- Clinical biochemistry findings:
- not examined
- Description (incidence and severity):
- No adverse effects were observed on weight, macroscopically or microscopically of/on organs nor on urinalysis, therefore adverse effects on clinical chemistry are not expected
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- Some differences were seen between the results of renal function tests for treated rats compared with control rats. No permanent disturbance of the renal system was apparent. Kidney functions were normal during the study, therefore, the increased water intake of 5000 ppm treated male and female rats in the first part of the 2-y study is not expected to be an adverse effect of the substance.
A trend of increased protein excretion in the urine of both control and treated rats was found. This is a characteristic of ageing rats, which severity or onset was not accelerated by the substance. - Behaviour (functional findings):
- not examined
- Description (incidence and severity):
- not required
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Although there was some suggestion of increased caecum weight in male rats given 5000 ppm substance in the interim studies, this increase was not seen in the corresponding group in the 2-y study. Other differences were seen (increased spleen weight, decreased intestinal weight both at 50 ppm in male rats, increased pituitary glands in female rats at 50 ppm), but never consistent over sexes or dose dependent. It was thus concluded that the increased organ weights were not a toxicological relevant adverse effect.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Occasionally a single histopathological finding was found with a higher prevalence in one or more groups (lung, liver). However, no clear dose trend is found, no consistent pattern is seen in the male and female groups, therefore it is unlikely that these differences can be attributed to the treatment. In addition, periartritis was seen, but not statistically significant, and this is commonly found in old rats. An increased number of fibrous polyps was seen in the uteri of high dose females, however this is commonly found in old female rats. Since no clear dose response is seen, this was considered not to be related to treatment.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- No dose related effect was seen in tumours of the pituitary, pancreas and thyroid, which are relatively common in aged rats. Basal cell carcinoma, lipoma, sarcoma, fiborsarcoma and squamous cell carcinoma were found either in the skin or subcutaneous tissues of several animals. However, these kind of tumours have frequently been reported in control rats and therefore, it is unlikely they result from treatment.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 630 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No dose-related carcinogenicity was observed up to the highest dose level tested.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 450 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No dose-related carcinogenicity was observed up to the highest dose level tested.
- Conclusions:
- In a long term (two year) toxicity study with rats performed mainly according to OECD 453, supplemented with two interim studies (49-51 weeks and 80-82 weeks respectively), male and females rats (48/dose) were daily exposed to sodium ferrocyanide, which was mixed in the diet. From these data, the NOAEL was determined to be ≥ 630 and ≥ 450 mg/kg bw/day for females and males, respectively, based on the absence of effects seen at the highest concentration (5000 ppm in the food). This result is read across to potassium ferricyanide.
- Executive summary:
In a long term (two year) toxicity study with rats, supplemented with two interim studies (49-51 weeks and 80-82 weeks respectively), male and females rats (48/sexe) were daily exposed to sodium ferrocyanide, which was mixed in the food. During the studies, body weight and food and water intake was monitored at regular intervals. Furthermore, blood and urine samples were examined for several relevant parameters. At the end of the study, rats were killed and organs and tissues were examined macro- and microscopically. Rats exposed to the highest concentration (5000 ppm in food) showed elevated water consumption in the first nine months. The sodium ferrocyanide in the diet did not adversely affect growth or general health of the rats in the three treatment groups. No dose-related variations were found in the haematology or urine analyses. Neither were dose-related differences found in the weight of the organs, or in the (non-neoplastic and neoplastic) histopathology of organs or tissues between the exposed groups or differences with the non-exposed groups. From these data, the NOAEL was determined to be ≥ 630 and ≥ 450 mg/kg bw/day for females and males, respectively, based on the absence of effects seen at the highest concentration (5000 ppm in the food). The results are read across to potassium ferricyanide.
Reference
Summary of tumour incidence in male rats fed sodium ferrocyanide in the diet at levels of o (control), 50, 500 or 5000 ppm for up to 105 weeks
|
Control |
50 ppm |
500 ppm |
5000 ppm |
Total animals/group |
48 |
47 |
48 |
48 |
Total primary tumors |
17 |
16 |
29 |
17 |
Total animals with tumors |
15 |
12 |
22 |
14 |
Total animals with multiple tumors |
2 |
3 |
5 |
2 |
Total benign |
13 |
14 |
22 |
10 |
Total malignant |
4 |
2 |
7 |
7 |
Total malignant with metastasis |
2 |
0 |
3 |
2 |
Summary of tumour incidence in female rats fed sodium ferrocyanide in the diet at levels of o (control), 50, 500 or 5000 ppm for up to 107 weeks
|
Control |
50 ppm |
500 ppm |
5000 ppm |
Total animals/group |
48 |
48 |
48 |
48 |
Total primary tumors |
41 |
41 |
34 |
37 |
Total animals with tumors |
36 |
33 |
29 |
27 |
Total animals with multiple tumors |
4 |
8 |
5 |
7 |
Total benign |
34 |
35 |
27 |
26 |
Total malignant |
7 |
6 |
7 |
11 |
Total malignant with metastasis |
1 |
0 |
4 |
2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 450 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- A reliable study is used (Klimisch 2).
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, potassium ferricyanide is not need to be classified for carcinogenicity according to CLP Regulation (No) EC 1272/2008.
Additional information
In a long term (two year) toxicity study rats, supplemented with two interim studies (49-51 weeks and 80-82 weeks respectively), male and females rats (48/sex) were daily exposed to sodium ferrocyanide, which was mixed in the food. During the studies, body weight and food and water intake was monitored at regular intervals. Furthermore, blood and urine samples were examined for several relevant parameters. At the end of the study, rats were killed and organs and tissues were examined macro- and microscopically. Rats exposed to the highest concentration (5000 ppm in food) showed elevated water consumption in the first nine months. The sodium ferrocyanide in the diet did not adversely affect growth or general health of the rats in the three treatment groups. No dose-related variations were found in the haematology or urine analyses. Neither were dose-related differences found in the weight of the organs, or in the (non-neoplastic and neoplastic) histopathology of organs or tissues between the exposed groups or differences with the non-exposed groups. From these data, the NOAEL was determined to be ≥ 630 and ≥ 450 mg/kg bw/day for females and males, respectively, based on the absence of effects seen at the highest concentration (5000 ppm in the food). This result is read across to potassium ferricyanide.
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