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Toxicological information

Carcinogenicity

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Description of key information

Potassium diformate lacked potential for carcinogenicity in rodents (rats and mice). This can be extrapolated to formic acid and other formate salts including potassium formate.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to guideline
Guideline:
OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
Species:
mouse
Sex:
male/female
Route of administration:
oral: feed
Duration of treatment / exposure:
80 weeks
Frequency of treatment:
7/week
Dose / conc.:
2 000 mg/kg bw/day (nominal)
Remarks:
Based on diet
Control animals:
yes
Histopathological findings: neoplastic:
no effects observed
Relevance of carcinogenic effects / potential:
Potassium diformate did not show potential for carcinogenicity in a mouse long-term rodent feed study.
Dose descriptor:
NOAEL
Effect level:
2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

SIAP attached, cf. section 13

Conclusions:
Potassium diformate did not show potential for carcinogenicity in a mouse long-term rodent feed study. This can be extrapolated to formic acid and other formate salts.
Executive summary:

In oral feed studies comparable to OECD TG 453, potassium diformate did not show potential for carcinogenicity in mice in an 80-week test using doses up to 2,000 mg/kg bw/d. It is unlikely that the other category members would have the potential to exhibit carcinogenicity (OECD, 2008).

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to guideline
Guideline:
OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
Species:
rat
Sex:
male/female
Route of administration:
oral: feed
Duration of treatment / exposure:
104 weeks
Frequency of treatment:
7/week
Dose / conc.:
2 000 mg/kg bw/day (nominal)
Remarks:
Based on diet
Control animals:
yes
Histopathological findings: neoplastic:
no effects observed
Relevance of carcinogenic effects / potential:
Potassium diformate did not show potential for carcinogenicity in a rat long-term rodent feed study.
Dose descriptor:
NOAEL
Effect level:
2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

SIAP attached, cf. section 13

Conclusions:
Potassium diformate did not show potential for carcinogenicity in a rat long-term rodent feed study. This can be extrapolated to formic acid and the other formate salts.
Executive summary:

In oral feed studies comparable to OECD TG 453, potassium diformate did not show potential for carcinogenicity in rats in a 104-week test using doses up to 2,000 mg/kg bw/d. It is unlikely that the other category members would have the potential to exhibit carcinogenicity (OECD, 2008).

Endpoint conclusion
Dose descriptor:
NOAEL
2 585 mg/kg bw/day

Justification for classification or non-classification

Criteria of regulations 67/548/EC and 1272/2008/EC not met.

Additional information

Potassium diformate did not show potential for carcinogenicity in two valid long-term rodent feed studies using rats and mice, respectively. This can be extrapolated to formic acid and other formate salts. The highest tested dose compares to 2585 mg potassium formate/kg bw/day.