Registration Dossier
Registration Dossier
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EC number: 266-442-3 | CAS number: 66669-53-2
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Expert evaluation; review
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Please find the Justification attached to Chapter 13.2
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Data source
Materials and methods
Test material
- Reference substance name:
- Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate
- EC Number:
- 266-442-3
- EC Name:
- Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate
- Cas Number:
- 66669-53-2
- Molecular formula:
- C7H7Na4O9P
- IUPAC Name:
- tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate
- Details on test material:
- generic test material
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- other: Review on all available data
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified Generation not specified
- Dose descriptor:
- other: Review on all available data
- Basis for effect level:
- other: BUA concluded that 2-phosphonobutane-1,2,4-tricarboxylic acid has no toxic potential and no risk to humans could be deduced.
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified Generation not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
OECD/SIDS concluded:
"The available information on toxicity gave no evidence of damage in doses up to 375 mg/kg body weight. There is no evidence of embryo-toxicity, teratogenicity or genotxicity. Based on the available data on toxicity and the data on occupational exposure and exposure of the general population, 2-phosphonobutane-1,2,4-tricarboxylic acid is of low concern."
BUA concluded that 2-phosphonobutane-1,2,4-tricarboxylic acid has no toxic potential and no risk to humans could be deduced.
In aqueous media, PBTCNa4 and PBTC dissociate into the corresponding anion (2-phosphonatobutane-tricarboxylate ion) and the sodium ion and hydrogen ion (proton), respectively. The toxicological properties of PBTC and its tetrasodium salt are thought to be an effect of the phosphonato-carboxylate ion rather than of the sodium ion or the hydrogen ion (proton), which are normal constituents in body fluids and have no relevant toxic properties in low concentrations.
Therefore a read-across between PBTCNa4 and PBTC acid is justified.
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