Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
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

Test animals

Species:
other: not tested

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

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

Results (fetuses)

Effect levels (fetuses)

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

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental 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 be 1000 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/IX for endpoint 8.7.