Registration Dossier
Registration Dossier
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EC number: 233-433-0 | CAS number: 10163-15-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
No study was selected since studies for all 3 in vitro genotox endpoints were negative.
Short description of key information:
In vitro gene mutation study in bacteria: Two studies are available for this endpoint;
- The GLP key study (Thompson 2010) is conducted according to OECD guideline 471. Under the conditions of this test, disodium fluorophosphate was considered to be non-mutagenic.
- A supporting study (Gocke 1981) is not conducted according to modern day standards and is therefore not considered as reliable evidence for this endpoint. Nevertheless, the published data supports the conclusions made in the key study.
In vitro cytogenicity study in mammalian cells: A single key study is available for this endpoint.
- The non-GLP key study (Ishidate 1988) is comparable to the current guideline (OECD 473) with acceptable restrictions. Under the conditions of this test, disodium fluorophosphate was considered to be non-clastogenic.
- In vivo studies (described below) support the findings made in the key study.
In vitro gene mutation in mammalian cells: A single key study is available for this endpoint.
- The key study (Flanders 2010) is conducted under the conditions of GLP and according to OECD guideline 476. Under the conditions of this test, disodium fluorophosphate was considered to be non-mutagenic.
In vivo cytogenicity study in mammalian cells: Two studies are available for this endpoint;
- The non-GLP key study (Gocke 1981) is equivalent to OECD guideline 475 with acceptable restrictions. Under the conditions of this test disodium fluorophosphate was considered to non-clastogenic, thus supporting the results obtained in the in vitro analysis.
- The supporting study (Hayashi 1988) is not considered to be sufficient as key data. The authors reported that the test material non-clastogenic.
In vivo gene mutation studies:
- The supporting study (Buchi 1981) is not considered to be sufficient as key data. The authors reported no mutagenic potential.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
In accordance with Regulation (EC) No 1272/2008, no classification for in vitro genetic toxicity is proposed because reliable in vitro studies in bacterial and mammalian cell lines indicated that the test material is negative for mutagenicity and clastogenicity.
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