Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2015

Materials and methods

GLP compliance:
no

Test material

Constituent 1
Reference substance name:
PMC D-532
IUPAC Name:
PMC D-532
Test material form:
other: waxy solid

Results and discussion

Any other information on results incl. tables

Physicochemical properties are available for PMC D-532. The water solubility is extremely low< 2x10-16mg/l and the partition coefficient extremely high (log Kow 19.1). The test substance has a low vapour pressure (1.1 Pa@ 1100C) indicating that it is not likely that vapours will reach the nasopharyngeal, tracheobronchial or pulmonary region. In addition, the substance is a waxy solid indicating that particles are not expected to enter respiratory tract and if so, they will most likely deposit in the nasopharyngeal region and subsequently be coughed or sneezed out of the body or swallowed. Subsequent absorption through pores is not likely taking into account the size of the particles. This assumption is also confirmed in 2 skin absorption studies (in vitro and in vivo studies) showing negligible adsorption of the test substance.

(1) Overall, it is concluded that if any PMC D-532 is inhaled absorption is not expected and for risk assessment purposes the inhalation absorption is set at 1%.

 

(2) The criteria for 10% dermal absorption as given in the REACH guidance (1) (<W > 500 and log Pow > 4) is met – 1% will be used in the risk assessment as realistic worst case estimate based on the available dermal adsorption studies.

 

(3) Oral adsorption is based on dermal adsorption. Conversion factor used is 1. Hence, for PMC D-532, a worst case adsorption factor of 1% will be used in the risk assessment.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results