Sodium formate

Carcinogenicity

Description of key information

Studies of carcinogenicity in the rat and mouse are available for the read-across substance, potassium formate (secondary sources).

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Reference

Reference 1

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 sodium formate.

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 2000 mg/kg bw/d. It is unlikely that the sodium formate would have the potential to exhibit carcinogenicity (OECD, 2008).

Reference 2

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 (actual dose received)

Based on:

test mat.

Sex:

male/female

Conclusions:

Potassium diformate did not show potential for carcinogenicity in a rat long-term rodent feed study. The results of this study can be extrapolated to sodium formate.

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 2000 mg/kg bw/d. It is unlikely, therefore, that sodium formate would have the potential to exhibit carcinogenicity (OECD, 2008).

Reference 3

Endpoint:

carcinogenicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across source

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 sodium formate.

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 2000 mg/kg bw/d. It is unlikely that the sodium formate would have the potential to exhibit carcinogenicity (OECD, 2008).

Reference 4

Endpoint:

carcinogenicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across source

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 (actual dose received)

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 sodium formate.

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 2000 mg/kg bw/d. It is unlikely, therefore, that sodium formate would have the potential to exhibit carcinogenicity (OECD, 2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

2 092 mg/kg bw/day

Study duration:

chronic

Species:

rat

Quality of whole database:

Studies of carcinogenicity in the rat and mouse are available for the read-across substance, potassium formate.

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

There is no indication of carcinogenicity in studies performed with potassium diformate in the rat and mouse. It can therefore be concluded that sodium formate is not carcinogenic and does not require classification according to CLP criteria.

Additional information

Potassium diformate, tested at dose levels of up to 2000 mg/kg bw/d; did not show a 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 is equivalent to 2120 mg sodium formate/kg bw/d.