Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
other: Assessment
Type of information:
other: Expert Assessment
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Expert assessment as opposed to experimental result

Data source

Reference
Reference Type:
other: Expert Assessment
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Principles of method if other than guideline:
Assessment
GLP compliance:
no
Type of study:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro / in chemico

Results
Remarks on result:
other: The substance in water has a pH of >13 due to the presence of residual sodium hydroxide and would be highly corrosive to skin due to the residual alkali; testing would not be required to show this as the properties of sodium hydroxide are well-known

Any other information on results incl. tables

Assessment

Applicant's summary and conclusion

Interpretation of results:
other: Not applicable
Executive summary:

This substance is the product of a reaction between Zircon (EC no 239-019-6) and sodium hydroxide. The substance in water has a pH of > 13 due to the presence of significant amounts of residual sodium hydroxide. The UVCB substance as produced would be highly corrosive to skin due to the residual alkali; testing would not be required to demonstrate this is the properties of sodium hydroxide are well-known. In vivo testing of the substance would be inappropriate on animal welfare grounds, and such testing for substances where the pH is >11 is prohibited. The substance is classified based on this as skin corrosion/irritation, category 1A (H314), i.e. corrosive. Disodium metasilicate (229-912-9) has been tested for skin sensitisation as have a number of zirconium salts. None of these would contribute at all to the corrosiveness due to the sodium hydroxide present in this substance. In view of the corrosive nature of this substance, its potential for sensitisation is irrelevant.

The above should be considered as an expert statement to waive the requirement for testing for skin sensitisation under REACH Annex VIII for endpoint 8.3