Poor Preservative Sensitization Data

Isobutylparaben

INCI: ISOBUTYLPARABEN

CAS Number
4247-02-3
Function
Preservative
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Not specifically banned in US cosmetics under FDA/MoCRA, but a long-chain paraben with documented endocrine disruptor activity that has no place in modern intimate care formulations.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Isobutylparaben based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
paraben-group
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; SCCS/1348/10

Expert Verdict

Long-chain paraben prohibited from EU cosmetics and proposed for the EU REACH Candidate List as an endocrine disruptor of very high concern. Estrogenic potency increases with alkyl chain length; isobutylparaben has significantly greater endocrine activity than short-chain methylparaben or ethylparaben. Intimate care-specific concern: formulation into products with prolonged mucosal contact would magnify endocrine exposure risks.

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Concern Level: High

Regulatory Flags

paraben eu-banned endocrine-disruptor reach-candidate long-chain-paraben intimate-avoid estrogenic eu_children_restricted

Frequently Asked Questions

Is Isobutylparaben safe in cosmetics?

Long-chain paraben prohibited from EU cosmetics and proposed for the EU REACH Candidate List as an endocrine disruptor of very high concern. Estrogenic potency increases with alkyl chain length; isobutylparaben has significantly greater endocrine activity than short-chain methylparaben or ethylparaben. Intimate care-specific concern: formulation into products with prolonged mucosal contact would magnify endocrine exposure risks. The EU classifies Isobutylparaben as "prohibited". Safety rating: POOR.

Is Isobutylparaben allowed in the EU?

Isobutylparaben EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Isobutylparaben do in cosmetics?

Isobutylparaben functions as: Preservative. It is classified as a Preservative in our database. CAS number: 4247-02-3.

What is the Margin of Safety for Isobutylparaben?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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