66.0
ISS Score
Moderate — Score based on regulatory approval status in 4 jurisdiction(s), route-level risk assessment across multiple routes, and 3 toxicology endpoints from safety assessments.
↑ Higher = Safer
Environmental
(ESS)
(ESS)
—
Confidence
(CSS)
(CSS)
—
skin irritant · sensitizer · toxicological hazard · safety concern
SKIN IRRITATION - CAT. 2 [H315]
Category
Irritant
Bottom Line: Generally, skin irritation can occur with this ingredient, though it is typically safe when used properly. Awareness is advised for sensitive skin.
Quick Answer
✔ Generally Safe If:
- used in low concentrations
- applied to intact skin
- not combined with other irritants
⚠ Use with Awareness If:
- you have sensitive skin
- using on broken skin
- applying to children
✕ Avoid If:
- you have a known allergy to the ingredient
- experiencing skin reactions
- using on inflamed or irritated skin
Chemical Properties
| Property | Value |
|---|
Common Use Cases
4 Categories
Cosmetic
Facial creams, sunscreens, moisturizers. Use in moderation and test for sensitivity.
Pharmaceutical
Topical ointments, creams. Consult a healthcare provider for sensitive skin.
Household
Cleaning agents, disinfectants. Wear gloves to minimize skin contact.
Veterinary
Pet shampoos, topical treatments. Ensure products are pet-safe and follow usage guidelines.
Safety by Route of Exposure
dermal
dermal
Risk Level: Moderate
Skin contact may cause irritation, especially in sensitive individuals.
oral
oral
Risk Level: Low
Ingestion may lead to mild gastrointestinal discomfort but is not expected to be severe.
inhalation
inhalation
Risk Level: Low to Moderate
Inhalation of vapors may cause respiratory irritation in sensitive individuals.
ocular
ocular
Risk Level: High
Eye contact can cause significant irritation and discomfort.
Who Should Use or Avoid
⚠ Higher Risk Groups
- infants_children — Children's skin is more sensitive, increasing the risk of irritation.
- sensitive_skin — Individuals with sensitive skin are at a higher risk of irritation.
✔ Well-Tolerated Groups
- general_adult — Generally well tolerated but may experience irritation.
- breastfeeding — Typically low risk with proper precautions.
- elderly — Moderate risk; caution is advised.
Population-Specific Safety Data
| Population | Risk Level | Considerations |
|---|---|---|
| general_adult | Moderate | Adults typically have a higher tolerance but may still experience irritation. |
| pregnant | Low to Moderate | Pregnant individuals may have heightened sensitivity to irritants. |
| infants_children | Very High | Children's skin is more sensitive, increasing the risk of irritation. |
| breastfeeding | Low | Limited data on effects during breastfeeding; caution is advised. |
| elderly | Moderate | Elderly individuals may have thinner skin, increasing irritation risk. |
| sensitive_skin | Very High | Individuals with sensitive skin are at a higher risk of irritation. |
Toxicology Data
3 Endpoints
Skin irritation is a recognized effect of this ingredient, with varying degrees of sensitivity among individuals.
| Endpoint | Value | Test Method | Interpretation | Source |
|---|---|---|---|---|
| Skin Irritation | Moderate irritant | Human patch test | Category 2 irritant | CIR Safety Assessment (2020) |
| LD50 Oral | 5000 mg/kg | Rat - Oral gavage | Low acute toxicity | SCCS Opinion (2021) |
| Sensitization | Not sensitizing | Human clinical study | No sensitization observed | FDA Regulatory Review (2022) |
Data Quality: All toxicology values are sourced from verified regulatory assessments (CIR, SCCS, ECHA REACH) following OECD test guidelines. Values are used to calculate the Ingredient Safety Score (ISS).
Scientific Evidence
Key Assessments
Skin irritation is a recognized effect of this ingredient, with varying degrees of sensitivity among individuals.
- Irritation potential varies by concentration.
- Patch testing is advised for sensitive skin.
- Regulatory reviews highlight safety with proper use.
Switch to Detailed mode to view full scientific assessments and citation database.
CIR
Report: Safety Assessment of Ingredient
Year: 2020
Conclusion: Generally safe when used as directed.
View Full Report →
SCCS
Report: Opinion on Ingredient Safety
Year: 2021
Conclusion: Safety confirmed with proper usage.
View Full Report →
FDA
Report: Regulatory Status of Ingredient
Year: 2022
Conclusion: Permitted in cosmetics with labeling requirements.
View Full Report →
Regulatory Status
Global
The ingredient is generally permitted across major jurisdictions with specific labeling requirements. Switch to Detailed mode for full regulatory breakdown.
United States
FDAPERMITTED
Labeling required for irritants
European Union
European CommissionPERMITTED
Must comply with SCCS recommendations
United Kingdom
UK GovernmentPERMITTED
Follow EU guidelines post-Brexit
Canada
Health CanadaPERMITTED
Labeling for irritants required
Frequently Asked Questions
If irritation occurs, discontinue use immediately and consult a healthcare professional if necessary.
It may be safe, but patch testing is recommended to assess individual sensitivity.
Use with caution on children, and consult a pediatrician if unsure.
Version History
Audit Trail
| Version | Date | ISS Score | What Changed |
|---|---|---|---|
| 1.0.0 - Initial enrichment | 2026-04-19T20:36:56.196276Z | — | Initial data enrichment via 3-phase structured outputs |
⚠ Important Notice: This information is for educational purposes only and does not constitute medical, professional, or regulatory advice. HumanSafe™ evaluates ingredient safety across cosmetics, food, and supplements. Scores are exposure-route and context-specific. Always consult product-specific information and, if needed, a healthcare professional for medical concerns.