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Administrative data

short-term repeated dose toxicity: dermal
Data waiving:
exposure considerations
Justification for data waiving:
Reason / purpose for cross-reference:
data waiving: supporting information
Log Pow (OECD Guidelines No. 117): < 0.3 

A GLP study was performed using a HPLC with a C18 column according to OECD Guidelines No.117. Six reference items with different retention times and thiourea for the determination of the dead time were used to produce a calibration curve, since retention time on hydrophobic columns and Pow are correlated. The reference items were chosen on behalf of the pre-test.

For each reference item, the capacity factor K was calculated from the retention time of thiourea and the retention time of the respective reference item. A calibration function (log K versus log linear fit) was determined using the literature values for Pow of the reference items and the retention times in the six determinations. The chromatogram of the test item gave one peak at 1.45 minutes. With the calibration function log K versus log Pow, the corresponding log Pow of the test item peak was not determinable, as the peak of the test item solution lay in the dead time of the method. Therefore, the log Pow of NEOSORB 70/70-LIQUID SORBITOL is stated as < 0.3 (lowest log Pow of the used references items in the mix).

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion