Preservative No. 11
Preservative for Cosmetics-Industry

Product-Description
Preservative No. 11 is based on a combination of Bronopol, Iodopropinylbutylcarbamate (IPBC) and Benzylic alcohol in a glycolic solution. It does not contain formaldehyde or substances that act as formaldehyde-releasers and conforms to the regulations of the EC cosmetics law.

Ranges of Application

Rinse-off-Cosmetics Preservative No. 11 has proven to be an effective preserving system for rinse-off-products like shampoos, shower-gels, foam-baths etc.
Care-Products Due to its good skin-compatibility Preservative No. 11 is suitable for high-quality care-cosmetics like creams, emulsions, lotions and gels. On account of its good dispensability it can be used in O/W-emulsions as well as in W/O-emulsions.
Wet tissues Preservative No. 11 has a strong fungicidal effect. Hence its use is recommended in products that are sensitive to mould, like wet tissues.



Dosage and Processing
Preservative No. 11 is used in cosmetic products in concentrations of 0.1 % to 0.2 %. When preserving simple surfactant-products sometimes dosages of 0.05 % are sufficient. Highly sensitive systems, like protein-creams or egg-shampoos or wet tissues may require quantities of 0.3 % to be added.
For the determination of the optimum dosage we recommend a test-preservation. On demand, our microbiological laboratory will give you the appropriate support.
When worked into products at ambient temperature Preservative No. 11 may be added at any phase of production. If heating is necessary - as during manufacture of creams - the addition of Preservative No. 11 is recommended after the product has cooled down below 40°C. Otherwise partial decomposition of active ingredients may occur.
Especially in aqueous products with low contents of emulsifiers intensive stirring is recommended, to achieve a quantitative solution of the IPBC-component.
It's not allowed to use Preservative No. 11, which contains Bronopol as active ingredient, together with nitrosable agents like Diethanolamides or Triethanolamine-salts. These substances contain Diethanolamine as impurity and so Nitrosamine (NDELA) can be developed.

Product Properties
- Microbiological Profile
The combination of biocides in Preservative No. 11 shows a broad and well balanced spectrum against gram-positive and gram-negative bacteria, yeast and fungi. Due to the fungicidal effect of the IPBC-component Preservative No. 11 especially is suitable for products that are sensitive to mould.

- Technical Data

Appearance : clear, yellow solution
Odour: characteristic
pH-Value: not applicable, glycolic solution
Density : 1.06 - 1.10 g/ml
Solubility: When diluted with water, turbid solutions will occur. In the range of the recommended use-concentrations Preservative No. 11 will not lead to dissipation-problems.



- Stability
Preservative No. 11 can be worked into final products at temperatures between 0 °C and 40 °C. PH-tolerance is given for acidic and neutral environment. Hydrolysis will take place at pH-values above 7. Nucleophils or reducing agents will lead to decomposition of the active ingredient. Elevated temperatures will accelerate this process.

- Toxicity and Dermatology
Acute toxicity: LD50 , rat, oral : 1000 mg/kg approx.
Skin-compatibility: The concentrate is irritant to skin, mucous membranes and eyes. At use-levels good skin-compatibility is observed. Preservative No. 11 is not a sensitizer.

- Labelling
According to EC-guideline 91/155 Preservative No. 11 has to be labelled with "Xn" (harmful). In the range of use-concentrations no labelling is necessary.

- Transport and Storage
Preservative No. 11 is not a hazardous substance in the sense of the transport-regulations (GGVE/GGVS/ ADR/RID). Storage is recommended in tight original-containers at temperatures between 5 °C and 25 °C.

INCI-Nomenclature

100-51-6   Benzyl Alcohol
13429-07-7, 34590-94-8   PPG-2 Methyl Ether
52-51-7   2-Bromo-2-Nitropropane-1,3-Diol
26183-52-8 (generic)   Deceth-8
55406-53-6   Iodopropynyl Butylcarbamate



Handling
During processing of Preservative No. 11 usual precautions for handling of chemicals are to be followed. Avoid contact with skin. Wear goggles and gloves. Clean skin with plenty of water and soap, flush eyes with water and buffer-solution.

The information contained in this leaflet is intended for your advice. It is in accordance with our best knowledge. However, no liability may be construed with respect to the results obtained in actual use.