Registration Dossier
Registration Dossier
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EC number: 209-677-9 | CAS number: 590-29-4
Carcinogenicity
Administrative data
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
- 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
- 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
- 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).
Referenceopen allclose all
SIAP attached, cf. section 13
SIAP attached, cf. section 13
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.
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