Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
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 results

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

Constituent 1
Chemical structure
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

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:
not measured/tested
Remarks:
zirconium has a low potential for systemic reproductive toxicity

Results: P1 (second parental generation)

Effect levels (P1)

Remarks on result:
not measured/tested
Remarks:
zirconium has a low potential for systemic reproductive toxicity

Results: F1 generation

Effect levels (F1)

Remarks on result:
not measured/tested
Remarks:
zirconium has a low potential for systemic reproductive toxicity

Results: F2 generation

Effect levels (F2)

Remarks on result:
not measured/tested
Remarks:
zirconium has a low potential for systemic reproductive toxicity

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Assessment

Applicant's summary and conclusion

Executive summary:

An OECD 422 test has been performed with zirconium acetate. The test results indicate that zirconium acetate is a substance of low toxicological potential as the NOAEL for reproduction/developmental toxicity was considered to be1000 mg/kg bw/day, the highest dose tested (based on anhydrous zirconium acetate). In addition, and based on the assessment of the available data, low absorption of zirconium acetate is expected. Taking into account all available information, it can be concluded that zirconium acetate neither affects fertility nor mating performance in rats of both sexes at doses up to and including 1000 mg/kg bw/day. On this basis, it can be concluded that zirconium has a low potential for systemic reproductive toxicity. In addition, the SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity. Based on these data sets, no further testing is required for silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide and no additional test is proposed.

The above should be considered as an expert statement to fulfil the REACH registration requirements under Annex VII and IX for endpoint 8.7.