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

Reference
Name:
Unnamed
Type:
Constituent

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

 

Endpoint

dihexadecyl peroxodicarbonate

MW

570.88

WS

 

Insoluble in water

MP

 

49.0°C to 57.0°C

Log Pow

15.5 (calculated)

VP

 

<< 0.01 Pa at20°C(calculated)

Skin irritation

Not irritating

 

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

 

NOTE:  Dihexadecyl peroxodicarbonate is classified as a peroxidetype D. 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” documentprovides 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 peroxide 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 peroxide 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 the peroxide will not be significantly absorbed via inhalation.

 

Oral Absorption

An OECD 422 oral gavage study, of the substance, in rats, did not result in any significant effects up to 1000 mg/kg bw/day. Based on the physico-chemical properties of the substance significant absorption is not expected.

 

Conclusion

While toxicokinetic data is not available on dihexadecyl peroxodicarbonate, based on the properties of the substance it is not expected to be absorbed to a great extent. Further information on distribution, metabolism or excretion is not available.