Reaction products of 2-hydroxyethyl methacrylate and diphosphorous pentoxide and water

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Remarks:

Registrant indicates - intention to read-across to test currently under (test proposal) assessment by the agency (ECHA). For further information see: ‘Justification for type of information’

Data waiving:

other justification

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.4 : appropriate in vivo mutagenicity studies shall be considered in case of positive result in any of the genotoxicity studies in Annex VII or VIII. With further reference to REACH Regulation (EC) No. 1907/2006 : Article 25(1) and Article 40 and in lieu of formal testing proposal on the present substance, the registrant intends to firstly adapt the information requirement according to REACH Regulation (EC) No. 1907/2006 Annex XI : section 1.5 : Grouping of substances and read-across approach, by utilising data generated associated with a test proposal already under agency (ECHA) assessment under REACH Regulation (EC) No. 1907/2006 : Article 40 and Article 41.

The registrant has contacted the agency (ECHA) and/or is contacting the test proposer in order to acquire access to the proposed and/or yet to be conducted study/studies.

NON-CONFIDENTIAL NAME OF (SOURCE) SUBSTANCE AND DETAILS OF TEST PROPOSAL
(associated with the test proposal not made by the current registrant, but which is intended to be used within the current registration):
- Name/identifiers: Reaction products of 2-hydroxyethyl methacrylate and diphosphorus pentaoxide (POEMA) ; EC/List Number: 810-703-1 / CAS Number: 1187441-10-6
- Details on the test proposal: According to the test proposer: “it is proposed to address the potential genotoxic properties of POEMA in an in vivo Comet assay. This assay addresses all potential mode-of-actions (the COMET assay recognises primary DNA damage that would lead to gene mutations and/or chromosome aberrations, but will also detect DNA damage that may be effectively repaired or lead to cell death), performance of this in vivo study is considered to be sufficient to conclude on this endpoint. The oral route is considered to be the most appropriate route. As no sex-specific toxicity is expected, the test is performed in a single species. As no tissue-specific toxicity is expected, blood and liver samples will be tested (sic).”
- Test Guideline: OECD TG 489 /
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- GLP compliance: YES
- Status: Under Agency (ECHA) assessment (2020/2021)

For the target substance: the aforementioned study will address the positive chromosome aberrations (precautionary conclusion, due to potentially artefactual positive results due to low pH of the test item replicates in comparison to the solvent control replicates) detected in an available OECD TG 473 in vitro chromosome aberration assay. This would provide further information in accordance with the requirements of REACH Regulation (EC) No. 1907/2006 Annex VIII, column 2 section 8.4 and/or REACH Regulation (EC) No. 1907/2006 Annex XI : section 1.5 : Grouping of substances and read-across approach. And is a required step prior to the proposal to test on the present (target) substance. The demonstration of ‘chemical similarity’ is provided between source and target is given in Section 13 of the current registration dossier.

References:
1. REACH Regulation (EC) No. 1907/2006 Annex VIII, column 2 section 8.4
2. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.7, July 2017)
3. REACH Regulation (EC) No. 1907/2006 Annex XI : section 1.5 : Grouping of substances and read-across approach
4. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.6: QSARs and grouping of chemicals, May 2008)
5. ECHA Read-Across Assessment Framework (RAAF), 2017 (as amended)

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information