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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

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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

Constituent 1
Chemical structure
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

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.