Registration Dossier
Registration Dossier
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EC number: 304-802-4 | CAS number: 94279-56-8
Repeated dose toxicity: dermal
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:
- 2 015
- Report date:
- 2015
Materials and methods
- Principles of method if other than guideline:
- Assessment
- GLP compliance:
- no
Test material
- Reference substance name:
- Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide
- EC Number:
- 304-802-4
- EC Name:
- Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide
- Cas Number:
- 94279-56-8
- Molecular formula:
- Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide
- IUPAC Name:
- Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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