Registration Dossier
Registration Dossier
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EC number: 270-393-3 | CAS number: 68427-35-0
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
A toxicokinetic assessment was performed based on the available data for the test material. Based on the physical/chemical properties of the test material, absorption factors for this test material are derived to be 50 % (oral), 100 % (inhalation) and 25 % (dermal) for risk assessment purposes. The bioaccumulation potential is expected to be low.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 25
- Absorption rate - inhalation (%):
- 100
Additional information
A toxicant can enter the body via the gastrointestinal tract, the lungs and the skin. In general, a compound needs to be dissolved before it can be taken up from the gastrointestinal tract after oral administration. The water solubility of the substance is very low (< 0.006 mg/L ) and the substance may therefore not readily dissolve into the gastrointestinal fluids. When the substance makes contact with the mucosal surface, the molecular weight (MW 413) and LogPow (2.2) are favourable for absorption via passive diffusion.
Taken together, limited oral absorption of the substance is expected based on its molecular weight and Log POW. For risk assessment purposes oral absorption is set at 50 %. The oral toxicity data do not provide reason to deviate from the proposed oral absorption factor. Yellow discoloration of the urine after oral exposure indicates systemic exposure and therefore oral absorption takes place.
For inhaled substances, the processes of deposition of the substance on the surface of the respiratory tract and the actual absorption have to be differentiated. Low vapour pressure (6.57 x 10^-19 mmHg) and a high boiling point (690.4 °C) indicate the substance has a low volatility. As the substance is a powder with at least 50 % of particles below 15 μm, it is likely that the substance will reach the nasopharyngeal region and subsequently the tracheo/bronchial/pulmonary region in humans via inhalation. If the substance reaches the tracheobronchial region, the rate at which the particles dissolve into the mucus can limit the amount that can be absorbed directly due to its low water solubility. However when the substance comes in contact with the respiratory epithelium, the log Pow (2.2) favours absorption. Based on this, for risk assessment purposes the absorption via inhalation of the substance is set at 100 %.
The substance is a powder which will have to dissolve into the surface moisture of the skin before uptake can begin. Dermal uptake of a substance with a water solubility below 1 mg/L is likely to be low. In the absence of any quantitative data and in line with the EC guidance on dermal absorption (EFSA Panel on Plant Protection Products and their Residues (PPR); Guidance on Dermal Absorption. EFSA Journal 2012;10(4):2665), 25% dermal absorption will be used for risk assessment purposes. This dermal absorption estimate is considered highly protective, given that the substance is a solid and, according to the latest version of the same guidance on dermal absorption (EFSA, Buist H, Craig P, Dewhurst I, Hougaard Bennekou S, Kneuer C, Machera K, Pieper C, Court Marques D, Guillot G, Ruffo F and Chiusolo A, 2017. Guidance on dermal absorption. EFSA Journal 2017;15(6):4873) the default value would be 10%.
Once absorbed, distribution of the test substance throughout the body is expected to be low based on its water solubility (<0.006 mg/L), molecular weight (413) and Pow (2.2). From the acute oral study in which yellow discoloration of the urine and faeces was observed, it can be deduced that the substance can be excreted via urine and faeces, likely via the bile. Based on its Pow (2.2), the substance is not expected to accumulate significantly in adipose tissue.
A toxicokinetic assessment was performed based on the available data of the substance. Based on the
physical/chemical properties of the substance, absorption factors for this substance are derived to be 50 % (oral), 100 % (inhalation) and 25 % (dermal) for risk assessment purposes. The bioaccumulation potential is expected to be low
[MD1]For consistency with the phys-chem section
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