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HIGH RISK

Should I Avoid formamidine sulfinic acid During Pregnancy? | VeriMom

Reviewed by · Last reviewed

ECHA regulatory hazard statements

  • H361

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Sources & references

Authoritative references used to score this ingredient.

Pregnancy-Safe Alternatives to formamidine sulfinic acid | VeriMom

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FAQ

Is formamidine sulfinic acid safe during pregnancy?
Animal reproductive/developmental data in the OECD SIDS report show reduced litter size and effects on corpora lutea at high doses and a NOAEL for reproductive performance of 15 mg/kg bw in rats, so reproductive hazard is suspected (h=2). No harmonised EU CMR Category 1 (H360/H350/H340) is listed for this substance on ECHA; the reproductive effects appear secondary to maternal toxicity rather than a characterised endocrine mechanism, so mechanism is scored as theoretical/demonstrated by animal study (m=1). Dermal/topical exposure is expected to give low but measurable systemic exposure (low logP, water soluble), so exposure score is 1. Sources: OECD SIDS (reproduction data) and ECHA substance record.
Is formamidine sulfinic acid safe while breastfeeding?
No human breastfeeding-specific data were found. Animal reproductive data (OECD SIDS) that indicate effects on reproductive performance support a suspected hazard during lactation (h=2). Mechanistic evidence is limited (m=1). Expected systemic exposure from topical use is low but measurable (e=1); transfer in milk is not documented.
Is formamidine sulfinic acid safe for baby skin?
No infant-specific studies were identified. Because animal reproductive/developmental toxicity exists (OECD SIDS), the same suspected hazard rating (h=2) is applied. Mechanistic data remain limited (m=1). Exposure for infants (0–3 yr) is increased by one point relative to adults because immature skin has higher absorption; therefore exposure is e=2 (adult e=1 → baby +1).
How does VeriMom score formamidine sulfinic acid?
VeriMom scores formamidine sulfinic acid at 27/100 (high risk) based on EU CosIng status, ECHA hazard classifications, and peer-reviewed PubMed studies. Our scoring pipeline is fully transparent.
What are pregnancy-safe alternatives to formamidine sulfinic acid?
See our curated list of pregnancy-safe alternatives to formamidine sulfinic acid based on similar function and a no-known-risks safety band.

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Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice. Safety scores are based on publicly available data and may not reflect all risks. Always consult your healthcare provider before using any product during pregnancy or breastfeeding.

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