Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: 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

Additional information on results:
Assessment

Any other information on results incl. tables

Assessment

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: Assessment
Executive summary:

According to REACH Annex IX section 8.4, column 2, no further in vivo testing is required if no positive results were obtained in any of the three in vitro studies performed according to REACH Annexes VII and VIII section 8.4. Test data for zirconium acetate (231-492-7) (in vitro) showed no potential for genetic toxicity; in addition, no effects in an in vivo test on silicic acid, sodium salt (215-687-4) were observed; an in vitro study on silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide is planned in order to confirm the absence of potential for genetic toxicity.

The above should be considered as an expert statement to fulfil the REACH registration requirements under Annex IX for endpoint 8.4.