Butylparaben: What the SCCS Concluded About Safety in Cosmetics
Butylparaben safety summary from SCCS/1651/23: SCCS conclusion, NOAEL, maximum concentration or conditions, and source-linked context.
Butylparaben is covered by SCCS/1651/23, an SCCS-family cosmetic safety opinion dated 2023-10-26. The opinion conclusion for this opinion is direct enough for a substance-specific summary: On the basis of safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe.
Core Opinion Facts
- Opinion: SCCS/1651/23
- Opinion date: 2023-10-26
- Primary substance: Butylparaben
- CAS: 94-26-8
NOAEL Values Cited in the Opinion
The no-observed-adverse-effect data below is shown only from the SCCS source fields for this opinion. It is not a calculated margin-of-safety output.
| Endpoint | Value | Unit | Study context |
|---|---|---|---|
| repeated_dose_toxicity | 325 | mg/kg bw/day | rat, F0 through F2 generations |
| developmental_no_effect | 1000 | mg/kg bw/day | rat, GD 6-19 |
| male_reproductive_no_effect | 1100 | mg/kg bw/day | rat, repeat_dose_oral_diet |
Maximum Concentration or Conditions
Conditions from the Opinion
On the basis of safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe.; /; In the absence of exposure data specific for children to Butylparaben in cosmetic products, potential safety concerns cannot be excluded..
How to Read This Safety Conclusion
The key point for formulators is the match between the named ingredient, the cited NOAEL, and the SCCS conclusion. A NOAEL is a study point of departure, not a standalone permission to use Butylparaben at any level. The SCCS conclusion and any concentration or product-type conditions remain the controlling context for cosmetic use.
The source also matters because SCCS opinions can be ingredient-specific. The internal ingredient page for Butylparaben should be treated as the substance hub, while SCCS/1651/23 is the opinion-level page for the committee record.
Practical Formulation Takeaway
For a formula review, start with the identity check: confirm the INCI name, CAS number, and opinion reference align with the material in the formula. Then compare the intended product type against the SCCS concentration or condition language above. If the formulation uses a different exposure route, product category, or concentration basis, the SCCS conclusion should not be stretched beyond what SCCS/1651/23 actually assessed.
Review Notes
The conservative reading is to keep Butylparaben tied to this exact opinion. The opinion number, date, NOAEL table, and condition language all travel together. If a later formula review uses a different CAS identity, product type, or concentration basis, the source should be checked again rather than reusing this summary as a blanket answer.
This page is therefore an indexable safety summary, not a replacement for the committee text. It gives search readers the core SCCS facts for Butylparaben and keeps the source handle visible for audit.
Source
- SCCS opinion: SCCS/1651/23
- Source file: sccs_o_275.pdf
- Extraction JSON: SCCS Scientific Opinions