Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Adequacy of study:
key study
Reliability:
other: Expert statement is attached.
Rationale for reliability incl. deficiencies:
other: No studies are available on the toxicokinetics, metabolism and distribution of dihexadecyl peroxodicarbonate. Predictions were made based on physical-chemical properties and information from tox. studies.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihexadecyl peroxodicarbonate
EC Number:
247-611-0
EC Name:
Dihexadecyl peroxodicarbonate
Cas Number:
26322-14-5
Molecular formula:
C34H66O6
IUPAC Name:
hexadecyl hexadecyloxy dicarbonate

Results and discussion

Applicant's summary and conclusion

Executive summary:

Basic Toxicokinetics for dihexadecyl peroxodicarbonate (CAS# 26322-14-5)


 


In order to fulfil the requirements for submission of a REACH dossier according to Annex IX of REACH Regulation (EC) No.1907/2006 (for substances >100 tones/year) andin absence of data on the toxicokinetics and dermal absorption, an assessment of toxicological behaviour is required.No studies are available on the toxicokinetics, metabolism and distribution of dihexadecyl peroxodicarbonate.


 


Below are some physical chemical properties of dihexadecyl peroxodicarbonate relevant for toxicokinetic behaviour:


 


 

































Endpointdihexadecyl peroxodicarbonate
MW570.88
WS Insoluble in water
MP 49.0°C to 57.0°C
Log Pow15.5 (calculated)
VP << 0.01 Pa at20°C(calculated)
Skin irritationNot irritating

 


There is no information on hydrolysis since the substance is readily biodegradable.


 


NOTE: Dihexadecyl peroxodicarbonate is classified as a peroxide type F. Flammability is an intrinsic hazard in this class. The Self-Accelerating Decomposition Temperature (SADT) of the substances is 40°C (reference SADT: CLP regulations 2.15.2.3 and UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, 5th revised edition, sub-sections 28.1, 28.2, 28.3 and Table 28.3.)


 


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.


The ECHA “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance May 2008” document provides guidance, which physico-chemical properties commonly determine oral, inhalatory and dermal absorption, distribution, metabolism and elimination of substances (Link: http://echa.europa.eu/documents/10162/13632/information_requirements_r7c_en.pdf)


 


 


Dermal Absorption


Low skin permeability features are characterized by high melting point, high molecular weight, low water and lipid solubility and a low vapour pressure. Therefore, the registered substance will not be significantly absorbed via the skin based on the values above.


The substance is not irritating to skin and increased absorption due to damaged skin is therefore not very likely. 


 


Inhalation Absorption


The measured vapor pressure of the registered substance was << 0.01 Pa. The substance is available as flakes and in powder form. For the flakes less than 1% w/w is <100 µm. For the powder 3.6% of the particles is < 100 µm of that fraction only 0.036% is <10 µm and no particles are <5 µm.


Based on the low vapor pressure and particle size inhalation of the registered substance appears very unlikely. However, if inhaled it absorption by the respiratory mucous tissue is expected to be very low based on its high molecular weight, very high logPow and very low water solubility.


 


Oral Absorption


Based on its physicochemical properties, the registered substance is also not expected to be readily absorbed via the gastrointestinal tract.


This is supported by acute as well as repeated oral toxicity studies (OECD 401, 422, 414, 408) which has been conducted in rats with either the registered substance or its structural analogue. None of the studies revealed any relevant adverse effects up to dose levels of 1000 mg/kg bw/day.


 


Conclusion


While no experimental toxicokinetic data are available for the registered substance, it is expected to be not absorbed to relevant amounts, based on its physico chemical properties. Further information on distribution, metabolism or excretion is neither available nor considered relevant in this case.