Registration Dossier
Registration Dossier
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EC number: 247-611-0 | CAS number: 26322-14-5
Endpoint summary
Administrative data
Link to relevant study record(s)
- 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.
- 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:
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 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.
Reference
Description of key information
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.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 100
Additional information
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:
| 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 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.
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.
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