Azeco Cosmeceuticals

AZECO COSMECEUTICALS BV - MUSSENBERG 1, 6049 GZ Herten, The Netherlands – Phone: +31 475 782540

SKIN : A ZELAIC ACID is not sensitizing in the guinea pig test according to OECD 406 at concentrations up to 50%. Also studies on analogues do not show sensitizing phenomena. No data available on germ cells. Experimental tests carried out on analogues show negative results in bacteria reverse mutation on S. typhimurium and genetic mutation and chromosome aberration tests on mammalian cells. No in vivo available experiments. In vitro experimental tests carried out on analogues show negative results in bacteria reverse mutation on S. typhimurium and genetic mutation and chromosome aberration tests on mammalian cells. The analogue DOCOSANOIC ACID (CAS 112-85-6) does not show any adverse effects on rats maternal and foetal development at the maximum dose (1000 mg/kg bw) according to OECD 422.

G ERM CELL MUTAGENICITY :

C ARCINOGENICITY :

R EPRODUCTIVE TOXICITY :

STOT- SINGLE EXPOSURE :

No available information

STOT- REPEATED EXPOSURE :

No available information

A SPIRATION HAZARD :

No available information.

S ECTION 12: E COLOGICAL INFORMATION

EC50 (72h, Algae ) > 100 mg/L ErC50 (72h, Algae ) > 67 mg/L

12.1. T OXICITY :

OECD 201 OECD 201

12.2. P ERSISTENCE AND DEGRADABILITY :

The substance is readily biodegradable.

12.3. B IOACCUMULATIVE POTENTIAL :

Based on the Log Kow ( PARTITION COEFFICIENT N - OCTANOL / WATER ) of 1,57 the BCF (B IO C ONCENTRATION F ACTOR ) of 3,162 can be estimated (BCFWINNT v.2.15). Therefore, Bioaccumulation potential is low. A ZELAIC ACID has a pKa ( DISSOCIATION CONSTANTS OF ORGANIC ACIDS IN AQUEOUS SOLUTION ) of 4.53, hence, for soil pH values between 5 and 9 it will be mostly ionized with a preferred partition into water. Moreover, the estimation of Koc (O RGANIC C ARBON ADSORPTION COEFFICIENT ) from Pow show a low adsorption potential to soil.

12.4. M OBILITY IN SOIL :

12.5. R ESULTS OF PBT AND V P V B ASSESSMENT :

Based on the available information A ZELAIC ACID does not respond to PBT and vPvB classification criteria.

12.6. O THER ADVERSE EFFECTS :

None known.

S ECTION 13: D ISPOSAL CONSIDERATIONS

REGULATION (EC) No 1907/2006 Date of Issue: 02/01/2020

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Date of Revision: - AZCO99 Revision Nr.: - Version Nr.: 1