Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: dermal
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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels

Remarks on result:
not measured/tested
Remarks:
The substance has a pH of around 12. The high pH makes repeated dose toxicity (oral) inappropriate for animal welfare reasons.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Assessment

Applicant's summary and conclusion

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. The high pH makes repeated dose toxicity (dermal) inappropriate for animal welfare reasons. Testing of this substance for chronic effects is unnecessary for the following reasons..        

1. Chronic effects that would result from systemic exposure to the zirconium ion are adequately addressed by 2 studies (Klimisch 1 and 2) by the oral route on zirconium acetate (qv).

2. Chronic effects that would result from systemic exposure to the silicate ion are adequately addressed by 3 studies on silicic acid, sodium salt

Thus, running a repeat dose toxicity (dermal) study would add nothing to the hazard assessment for this substance, and risk management measures are driven primarily by its corrosive nature due to the high pH. Determination of chronic toxicity is therefore considered inappropriate and unnecessary.

The above should be considered as an expert statement to waive the requirement for testing for acute toxicity by the dermal route in REACH Annexes VIII and IX for endpoint 8.6.1 and 8.6.2.