Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 study endpoints found for Benzisothiazolinone. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 69 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 150 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 0.2 other | oral | rat | oral | REACH |
| NOAEL | 5 mg/kg bw/day | other | dog | oral | REACH |
Sensitization Profile
Contact sensitization data for Benzisothiazolinone based on clinical patch test studies and IFRA standards.
Source: NACDG 2021-22; ESSCA 2019/20
Expert Verdict
Isothiazolinone-class preservative emerging as a replacement for methylisothiazolinone (MI) following the EU ban. As MI has been removed from intimate wipes and personal care, BIT usage has increased and early sensitization signals are appearing in clinical patch-test surveillance. Structurally related to MI/MCI with potential for cross-reactivity in MI-sensitized individuals and independent sensitization. Identified as an emerging concern in intimate care contexts by clinical reviewers. Formulators should monitor dermatological society position statements and consider non-isothiazolinone preservation alternatives for intimate wipe products.
Regulatory Flags
Frequently Asked Questions
Is Benzisothiazolinone safe in cosmetics?
Isothiazolinone-class preservative emerging as a replacement for methylisothiazolinone (MI) following the EU ban. As MI has been removed from intimate wipes and personal care, BIT usage has increased and early sensitization signals are appearing in clinical patch-test surveillance. Structurally related to MI/MCI with potential for cross-reactivity in MI-sensitized individuals and independent sensitization. Identified as an emerging concern in intimate care contexts by clinical reviewers. Formulators should monitor dermatological society position statements and consider non-isothiazolinone preservation alternatives for intimate wipe products. The EU classifies Benzisothiazolinone as "restricted". Safety rating: MODERATE. 4 toxicological study endpoint(s) are available in our database.
Is Benzisothiazolinone allowed in the EU?
Benzisothiazolinone EU regulatory status: restricted. Maximum allowed concentration: Permitted in rinse-off cosmetics; restricted or banned in leave-on products. This is based on EU Regulation 1223/2009 and its amendments.
What does Benzisothiazolinone do in cosmetics?
Benzisothiazolinone functions as: Preservative; biocide. It is classified as a Preservative in our database. CAS number: 2634-33-5.
What is the Margin of Safety for Benzisothiazolinone?
adequate 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.
What is the NOAEL for Benzisothiazolinone?
The NOAEL (No Observed Adverse Effect Level) for Benzisothiazolinone is 69 mg/kg bw/day based on a oral study via oral route in rat. A total of 4 study endpoints are available. Source: REACH.
Compliance Tools
Check Benzisothiazolinone compliance across multiple jurisdictions:
Related Ingredients
Is Benzisothiazolinone in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Benzisothiazolinone in your formulation.