Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
2010
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Principles of method if other than guideline:
- For routine measures in the plant on produced batches: pH measured at 25°C with a pH-meter Seven Easy (METTLER TOLEDO)
- for pH measure preliminary to the in vivo skin irritation assay: Merck-pH paper
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

pH valueopen allclose all
pH value:
5 - 7
Temp.:
25 °C
Remarks on result:
other: specifications for the substance as produced
pH value:
6
Temp.:
20 °C
Remarks on result:
other: test substance as described in section 1

Any other information on results incl. tables

pH is measured routinely on the batch solutions as produced at the plant.

The pH measured on the test substance preliminary to the in vivo skin irritation study was consistent with the range of concentrations for the substance produced in aqueous solution.

Applicant's summary and conclusion

Executive summary:

The plant specifications for the substance in aqueous solution are pH 5.0 to 7.0.