Table 3.
Comparison of concentrations with sensitising effects in human (HRIPT) or in mice (LLNA) to the estimated concentrations of application in products of daily use
| Active substance | Sensitising concentration in human (HRIPT) | Sensitising concentration in animal testing (LLNA) | Concentration of application | ||
|---|---|---|---|---|---|
| Cleaning & washing | Cosmetics | Home improvement | |||
| CMI/MI | 12.5 ppm [26](challenge conc. 12.5 ppm) | 75 ppm (EC3) [27] | ≤ 60 ppm | 2.5 - 7.5 ppm (15 ppma) | |
| Glutardialdehyde | 5% [28](challenge conc. 0.5%) | 0.1% (EC3) [29] | 0.01 - 0.5% | ≤ 0.1% (0.1%a) | |
| Formaldehyde | 1% [28](challenge conc. 1%) | 0.35% (EC3) [30] | ≤ 0.05% | ≤ 0.2% (0.2%a) | ≤ 0.1% |
| Bronopol | 5% [28](challenge conc. 2.5%) | 0.0011 - 0.035% | 0.01 - 0.1% (0.1%a) | 0.0011 - 0.035% | |
| Chloroacetamide | 0.5% [31](challenge conc. 0.5%) | 0.1 - 0.3% | ≤ 0.3% (0.3%a) | 0.1 - 0.3% | |
CMI/MI = mixture of 5-chloro-2-methyl-2H-isothiazolin-3-one and 2-methyl-2H-isothiazolin-3-oneHRIPT: Human Repeat Insult Patch test
LLNA: Local lymph node assay
EC3: concentration leading to a triplicate proliferation rate in the Local lymph node assay.
a = max. value of cosmetics directive [17]