Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
other: reviews from authorities
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Reviews so no primary information, however prepared by recognised authorities, Scientific Committees and WHO.

Data source

Referenceopen allclose all

Reference Type:
other: Toxicological evaluation by WHO
Title:
Toxicological evaluation of some food colours, emulsifiers, stabilizers, anti-caking agents and certain other substances
Author:
WHO
Year:
1969
Bibliographic source:
FAO Nutrition Meetings Report Series, No. 46A WHO/FOOD ADD/70.36, IPCS WHO
Reference Type:
other: Toxicological evaluation by WHO
Title:
Toxicological evaluation of some food colours, enzymes, flavour enhancers, thickening agents, and certain food additives
Author:
WHO
Year:
1975
Bibliographic source:
WHO Food Additives Series 6, IPCS WHO
Reference Type:
other: Scientific Committee Opinion
Title:
Opinion of the Scientific Committee for Animal Nutrition on the safety of Potassium- and Sodium Ferrocyanide used as anticaking agents
Author:
EU Health & Consumer Protection Directorate-General
Year:
2001
Bibliographic source:
OJ EC no. L248

Materials and methods

GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Physical appearance: (light) yellow crystals

Results and discussion

Any other information on results incl. tables

The 1969 WHO report was updated in 1975:

In an acute oral toxicity study in rats, the LD50 was 1600 -3200 mg/kg bw (1958).

Groups of 10 male and 10 female rats were maintained for 13 weeks on diets containing 0, 0.05, 0.5 and 5.0% sodium ferrocyanide. Growth rate and food consumption

was normal except at the 5% level, where there was slight depression. Haematocrit and haemoglobin values were depressed at the 5% level. Kidney weight of

both males and females at the 5% level and females at the 0.5% level was increased as were male adrenal and female pituitary gland weights in the 5% group.

The kidneys of rats at the 0.5% level showed a minimal degree of tubular damage. The effect was more marked at the 5% level, in addition granular and calcified

deposits were observed (Oser, 1959).

Human studies have demonstrated that i.v. injected ferrocyanide is excreted by glomerular filtration. Some tubular reabsorption occurs in man but not in dogs.

High levels were nephrotoxic in the short-term study in rats, but studies in dogs and man showed no adverse effects. No long-term studies are available (Remark of registrant: there are studies available currently).

Level causing no toxicological effect
Rat: 0.05% (= 500 ppm) in the diet equivalent to 25 mg/kg bwEstimate of acceptable daily intake for man:0 -0.025 mg/kg bw
   Estimate of acceptab
    
    

ve demonstrated that i.v. injected ferrocyanide is excreted by glomerular filtration. Some tubular

reabsorption occurs in man but not in dogs. High levels were nephrotoxic in the short-term study in rats, but studies in

Applicant's summary and conclusion