Registration Dossier
Registration Dossier
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EC number: 401-990-0 | CAS number: 106990-43-6 CHIMASSORB 119; LOWILITE 19
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The assessment of PBT/vPvB properties has been done on the basis of the data available from the testing programme as well as from some calculated approaches.
- Likely routes of exposure:
Persistent assessment
On the basis of a ready biodegradation study, HALS11 resulted “not readily biodegradable”. This results is also confirmed by the ready biodegradation study on the similar substance Uvasorb HA88.
Moreover, as HALS11 is a quite insoluble substance, it is not expected to undergo to hydrolysis.
No transformation products are expected as no hydrolytic behaviour has been recorded experimentally (< 10% at pH 4).
As a consequence of its low solubility, HALS11 is not expected to distribute in the aquatic compartment and the substance is not expected to enter into the atmosphere because of the low vapour pressure of the similar substance Uvasorb HA88 (7 ∙ 10-13kPa at 20 °C).
In soil, HALS11 is expected to have a low mobility, based on the value of the predicted absorption/desorption coefficient (Koc) of 5,560 (L/kg), and therefore it can accumulate in soil.
However, the exposure assessment shows that under adequate control measures, negligible releases to the environmental compartments are expected to occur during the life-cycle.
As a result of the previous data, the substance will not undergo to significant degradation or hydrolysis.
Therefore the substance meets the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent”.
Bioaccumulation assessment
The substance is not expected to bioaccumulate in aquatic organisms. Although the relatively high logPOW value, it is expected to be very poorly absorbed through oral and dermal routes, due to its high molecular weight and of its logPOW higher than 4 (4.50 at pH =7) (Milman and Weisburger, 1994; European Commission, 2004).
Furthermore, the results of a toxicokinetics study on mammals, confirm that the substance is completely excreted after oral administration and therefore the probability of a bioaccumulation is very low.
On the basis of the above considerations, HALS11 is not expected to bioaccumulate.
Toxicity assessment
The L(E)C50values were > 119, 7.3 and 1.2 mg/L for fish (96 hours), daphnia (48 hours) and algae (72 hours), respectively. Although long-term data on aquatic organisms are not available, a very low NOEC (< 0.01 mg/l) can be assumed basing on the low value of algal EC50.
On the basis of the above consideration, it can be reasonably assumed that the substance meets the criteria ofAnnex XIII of Regulation EC 1907/2006 for the classification as “Toxic”.
Summary and overall conclusions on PBT or vPvB properties
On the basis of the available data, HALS11 is not expected to degrade neither by biotic nor abiotic pathways. Although environmental emissions are negligible, the substance, if released in the environment, is not expected to bioaccumulate in the aquatic organisms. HALS11 is however expected to be toxic for aquatic organisms (algae).
In conclusion, considering all the available data, the substance meets the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “ Persistent” and “Toxic”, but it does not meet the criteria for the “Bioaccumulation” endpoint. Therefore HALS11 is not considered to be neither a PBT nor a vPvB substance.
Emission characterization
Because the substance does not fulfil the PBT and vPvB criteria, no emission characterisation is performed. Furthermore on the basis of the risk characterisation, the risk is evaluated as adequately controlled during all steps of life cycle.
References.
Milman and Weisburger, 1994. Handbook of Carcinogen Testing. William Andrew. 856 pages.
European Commission, Health and Consumer Protection Directorate, 2004. Guidance Document on Dermal Absorption. Sanco/222/2000 rev.7.
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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