CLARIANT
Regulatory Product Information
Only Valid for Use in Cosmetics (Version 2.0)
Nipasol M
1. General Information
1.1 Trade name Nipasol ® M
1.2 Manufacturer / Supplier Clariant Produkte (Deutschland) GmbH,
(address, phone no., fax no., contact 65926 Frankfurt
person)
Application Development Personal Care
Phone: +49 (0)69 305 18172
Fax: +49 (0)69 305 38467
•
Corporate Product Stewardship
Phone: +49 (0)6196 757 6228
Fax: +49 (0)6196 757 6244
1.3 Raw material category Preservative
1.4 Chemical name Propyl 4-hydroxybenzoate
1.5 INCI (CTFA) name Propylparaben
Composition
1.6 EC (EINECS/ELINCS) no. 202-307-7
1.7 CAS no. 94-13-3
Listed on the chemical inventories of European
1.8 Registration status
Union (EINECS), Switzerland, United States (TSCA),
(e.g. EU, US, Japan) Canada (DSL), Japan (ENCS), China, Korea (KECI),
Philippines, Australia (AICS), New Zeeland (NzloC).
1.9 Regulations for cosmetic use In conformity with the requirements relevant to
cosmetic ingredients of the Cosmetics Regulation
(EC) 1223/2009.
Europe: 0,14 % (as acid) for the sum of the individual
concentrations, and 0,8 % (as acid) for mixtures of
substances mentioned in entry 12 and 12a, where
the sum of the individual concentrations of butyl- and
propylparaben and their salts does not exceed
0,14%, Regulation (EC) 1004/2014.
Not to be used in leave-on products designed for
application on the nappy area of children under
three years of age.
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CLARIANT
Regulatory Product Information
Only Valid for Use in Cosmetics (Version 2.0)
Nipasol ® M
Japan: maximum concentration 1 % in cosmetic
product, no restrictions.
USA: considered safe as used by Cosmetic
Ingredient Review (2006), Propylparaben up to 0.4%
if used alone (paraben mixes up to 0.8%)
1.10 Country of origin China
2. Information on Production
2.1 Origin of starting material synthetic
(plant, animal, synthetic) Product is based on materials which do not originate
from animal sources and which are not produced
from genetically modified material.
2.2 Does the material contain Product does not contain genetically modified
genetically modified organisms (GM0s).
organisms?
2.3 Information on production Esterification of para-Hydroxybenzoic acid with n-
process Propanol
(general description)
3. Additives
3.1 Preservatives The product is a preservative.
3.2 Antioxidants not added by recipe
3.3 Solvents not added by recipe
3.4 Bleaching agents not added by recipe
3.5 Fragrances (Allergens) not added by recipe
according to the European
Cosmetics Regulation (EC)
1223/2009, Annex Ill
3.6 CMR classified ingredients not added by recipe
3.7 Dangerous ingredients See EU safety data sheet, chapter 2 or 3 (regulatory
according to Annex I of information, hazardous components).
Directive 67/548/EEC resp.
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CLARIANT
Regulatory Product Information
Only Valid for Use in Cosmetics (Version 2.0)
Nipasol 0 M
Annex VI of Regulation
(EC)1272/2008 or ingredients
self-classified as dangerous
3.8 Others Food allergens as of Directive 2000/13/EC (as
amended), Annex lila and Regulation (EU)
1169/2011, Annex II are not added by recipe.
4. Microbiological Specification
4.1 Total viable count < 10
(colony-forming units/g)
5. By-products
The presence of traces of the substances listed in Annex II of Regulation
(EC)1223/2009 (incl. cmr category. I-Ill substances marked with *) shall be allowed
provided that such presence is technically unavoidable in good manufacturing practice
and that it conforms with Article 3 of Regulation (EC)1223/2009.
5.1 1,4-Dioxane * not expected from the process
5.2 Ethylene oxide * not expected from the process
5.3 Residual solvents Ethanol < 0.2 %, n-Propanol < 0.5 %
5.4 Residual monomers not expected from the process
5.5 Amines not expected from the process
5.6 Nitrosamines not expected from the process
5.7 Heavy metals max. 10 ppm
typical values: Ni,Cr,Co,Cd,Hg,Pb,As,Sb,
each < 1 ppm
5.8 Monochloroacetic acid not expected from the process
5.9 Dichloroacetic acid not expected from the process
5.10 Phthalates not expected from the process
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CLAR IANT
Regulatory Product Information
Only Valid for Use in Cosmetics (Version 2.0)
Nipasol ® M
5.11 Pesticides Based on information concerning raw materials,
production process and equipment used, pesticides
are not likely to be present.
5.12 Glycol ethers Based on information concerning raw materials,
production process and equipment used,
Butyldiglycol, Ethyldiglycol and 2-Butoxyethanol are
not likely to be present.
5.13 Others p-HBA < 0.5 %
6. Toxicology
6.1 Information on acute toxicity LD50 > 5000 mg/kg (rat), Method: OECD 401
6.2 Information on skin irritation
Skin, rabbit: slightly irritant
(Cosmetic Ingredient Review, 1984)
6.3 Information on irritation of the Method: OECD 437
mucous membrane non corrosive / not severe irritant to the eye
Method: OECD 405
Not irritant
6.4 Information on sensitisation Not a skin sensitiser.
potential
(Cosmetic Ingredient Review, 1984)
6.5 Information on gene toxicity Method : OECD 476
In vitro Mammalian cell gene mutation assay,V79
cells (embryonic lung fibroblasts) of the Chinese
hamster
Not mutagenic
6.6 Information on percutaneous Skin permeability coefficient (guinea pig):
permeation
Kp 66,3 10 cm/h
(Cosmetic Ingredient Review, 2006)
6.7 Others 14-Day Dose Range Finding Study
Based on the results the dietary concentrations of 0,
1500, 4500, and 15000ppm were considered
suitable for the subsequent main Combined
Repeated Dose Toxicity Study with the
Reproduction/Developmental Toxicity Screening
Test in the Han Wistar Rat
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CLAR IANT
Regulatory Product Information
Only Valid for Use in Cosmetics (Version 2.0)
Nipasol M
7. Ecology
7.1 Degradability/Elimination
Aerobic biodegradation:
91% at 28 days, OECD 301F
The product is readily biodegradable
according to OECD criteria.
7.2 Acute aquatic toxicity Fish (Brachydanio rerio): Method: OECD 203, 96 hr,
LC50 6.4 mg/L
Daphnie (Daphnia magna): 48 hr, EC50 15.4 mg/L
(source literature)
Algae (P. subcapitata): Method: OECD 201,
72 hr, EC50 16 mg/L
7.3 Others
8. Additional Information
(For details on specification see enclosed instruction sheet; for details on labelling and
classification see enclosed safety data sheet.)
8.1 Nanomaterial Product is not considered as a nanomaterial
according (EC);No.1223/2009 definition art.2 (1k).
, /1
Date 11, 2(Y112_
Regulatory Affairs Manager
(Dr. Lärnmermann)
This information corresponds to the present state of our knowledge and is intended as a general description of
our products and their possible applications. Clariant makes no warranties, express or implied, as to the
information's accuracy, adequacy, sufficiency or freedom from defect and assumes no liability in connection with
any use of this information. Any user of this product is responsible for determining the suitability of Clariant's
products for its particular application. *Nothing included in this information waives any of Clariant's General Terms
and Conditions of Sale, which control unless it agrees otherwise in writing. Any existing intellectual/industrial
property rights must be observed. Due to possible changes in our products and applicable national and
international regulations and laws, the status of our products could change. Material Safety Data Sheets providing
safety precautions, that should be observed when handling or storing Clariant products, are available upon
request and are provided in compliance with applicable law. You should obtain and review the applicable Material
Safety Data Sheet information before handling any of these products. For additional information, please contact
Clariant.
For sales to customers located within the United States and Canada the following applies in addition
NO EXPRESS OR IMPLIED WARRANTY IS MADE OF THE MERCHANTABILITY, SUITABILITY, FITNESS FOR
A PARTICULAR PURPOSE OR OTHERWISE OF ANY PRODUCT OR SERVICE.
5
CLARIANT
Clariant Produkte (Deutschland) GmbH
CERTIFICATE OF COMPOSITION
Trade Name or Proposed Name: Nipasol M
INCI Name Concentration CAS number EINECS number Function
Propylparaben 100 `)/0 94-13-3 202-307-7 Active
Company representative: Dr. Dieter Lämmermann Date:
Function : Manager of Product Stewardship Signa
Geschäftsführer: Handelsregister: Sitz der Bankverbindung:
Oliver Kinkel (Vorsitz)
Lars Jansson
Frankfurt am Main
HRB 103782 Gesellschaft: Deutsche Bank AG
IBAN: DE4i500700t00092415900 EUR
Frankfurt am Main IBAN: DE84500700100092415902 USD
SWIFT: DEUTDEFF)00(
Aufsichtsratsvorsitzender:
Patrick Jan}