Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
See discussion in the original assessment reports for the notification of the substance under directive 67/548/EEC about path, frequency and duration of exposure from the substance.
No data about toxicokinetics, absorption, distribution, biotransformation and excretion paths are available for the registrant. The most likely routes of exposure are dermal during production of the substance and by workers or professionals and consumers by dermal or accidental oral exposure.
The route of inhalation is very unlikely with a substance with a very low vapour pressure and in a polymer matrix.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

Discussion about bioaccumulation potential.

A QSARvalue of Bioconcentration factor (BCF) was retrieved (11 Nov. 2010) to assess the potential for bioaccumulation. An experimental log Kow value (from the registrant) is available and this value was used in the software EPISUITE BcFwin ver. 2.15 (free from US EPA). The SMILE notation used for the BCF calculation was created with the software Toxtree 2.1.0. This software is free available from Joint Research Centre. BCF is not required in the original notification dossier and not according to the REACH regulation in the actual tonnage band of the registration.

Result was: BCF 24.

The formula used was a linear regression that is most suitable with a log Kow < 4, according to ECHA Guideline on information requirements for the Chemical Safety Report R7c, section R7.10.3.2. The BCF value retrieved by QSAR methods could vary depending on the algorithm and method used, but it is not likely that a value would be > 500 if one use the experimental logKow.

Conclusion of the calculation is that the Gelpaste Urea has a rather low potential for bioaccumulation.

Water solubility 0.05 mg/l.

No data about toxicokinetics, absorption, distribution, biotransformation and excretion paths are available for the registrant. The most likely routes of exposure are dermal and inhalation during production of the substance. The contact and possible uptake are however low. The substance is placed on the market in a polymer matrix and uptake in any organism will be very limited because this form probably makes the substance less biologically available.

Discussion about bioaccumulation potential.

A QSARvalue of Bioconcentration factor (BCF) was retrieved (11 Nov. 2010) to assess the potential for bioaccumulation. An experimental log Kow value (from the registrant) is available and this value was used in the software EPISUITE BcFwin ver. 2.15 (free from US EPA). The SMILE notation used for the BCF calculation was created with the software Toxtree 2.1.0. This software is free available from Joint Research Centre. BCF is not required in the original notification dossier and not according to the REACH regulation in the actual tonnage band of the registration.

Result was: BCF 24.

The formula used was a linear regression that is most suitable with a log Kow < 4, according to ECHA Guideline on information requirements for the Chemical Safety Report R7c, section R7.10.3.2. The BCF value retrieved by QSAR methods could vary depending on the algorithm and method used, but it is not likely that a value would be > 500 if one use the experimental logKow.

Conclusion of the calculation is that the Gelpaste Urea has a rather low potential for bioaccumulation.

Water solubility 0.05 mg/l.

No data about toxicokinetics, absorption, distribution, biotransformation and excretion paths are available for the registrant. The most likely routes of exposure are dermal and inhalation during production of the substance. The contact and possible uptake are however low. The substance is placed on the market in a polymer matrix and uptake in any organism will be very limited because this form probably makes the substance less biologically available.