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EC number: 257-077-0
CAS number: 51240-95-0
1,1,3,3-tetramethylbutyl peroxyneodecanoate is unstable with a hydrolysis half life less than 24 hours at 15°C (OECD111).The pure peroxide is not commercially available and always used in closed systems. Due to its instability, a phlegmatizer is added. Therefore the commercial product is always a mixture of peroxide and phlegmatizer.
Multiple breakdown products were identified (Datta, 2012). The breakdown products were not quantified. 1,1,3,3-tetramethylbutyl peroxyneodecanoate is converted to TMBH hydroperoxide (CAS#5809-08-5) which is broken down to neopentyl alcohol (CAS#75-84-3). Other breakdown products are 2,2,4-trimethylpentanol-2 (CAS# 123-44-4) and acetone (CAS# 67-64-1).
The available physico-chemical and toxicological information of the substance has been evaluated and used to assess the toxicological behaviour. The results of this analysis will address the question on how the chemical will react in the body.
Based on the log Pow of 6.9, the peroxide is expected to stay partitioned in the phlegmatizer. Based on the log Pow of 6.96, vapor pressure and water solubility, the phlegmatizer is not expected to penetrate the skin to a significant degree. Therefore, the peroxide would not be expected to be significantly absorbed either. The substance is mildly irritating to skin and increased absorption due to damaged skin is therefore not very likely.
If absorbed however, the peroxide would quickly undergo thermal decomposition to multiple breakdown products at body temperature.
The measured vapor pressure of the peroxide isododecane mixture was <0.24 Pa at 25°Cand of the peroxide 0.0001-0.01Pa. Based on the low vapor pressure and pattern of use, inhalation is not expected to be a major route of exposure. If inhalation of the peroxide does occur, as stated above it will rapidly decompose to multiple breakdown products.
In repeated oral gavage studies with the peroxide (70%) in phlegmatizer, findings were noted in kidneys of male rats (alpha-2μ-globulin) and livers of male and female rats (higher mean liver weight and hepatocellular hypertrophy). The liver effects were considered adaptive and the alpha-2μ-globulin is specific to the male rat with no human relevance.
In a 90-day oral gavage study reported in the REACH disseminated dossier, the phlegmatizer was administered to rats at 500, 2500 and 5000 mg/kg/day. Similar liver findings were reported at 2500 and 5000 mg/kg/day and similar kidney effects in all dose groups.
While it is not possible to establish the causative agent of the findings noted in the 28-day study with the product (i.e. the solvent or peroxide), the peroxide is expected to quickly decompose to multiple breakdown products at body temperature .
While toxicokinetic data is not available on 1,1,3,3-tetramethylbutyl peroxyneodecanoate, if absorbed, it is expected to be rapidly converted to multiple breakdown products. 1,1,3,3-tetramethylbutyl peroxyneodecanoate is not expected to bioaccumulate.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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