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Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
one-generation reproductive toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In the assessment of calcium dihydrogenphosphite (Ca(H2PO3)2, CAS 13780-04-6), a read-across approach is followed based on the information available for potassium phosphonate (KH2PO3/K2HPO3 EC 915-179-9). This read-across strategy is based on the hypothesis that the phosphite anion is the driver for the ecotoxicological and toxicological effects of both salts.The read-across hypothesis is justified by the immediate dissociation of calcium dihydrogenphosphate and potassium phosphonate upon dissolution in aqueous media. Both phosphite salts are highly soluble (>200 g/L) and are only present in their dissociated form in solution, i.e. the calcium or potassium cation and the phosphite anion. The transformation of the salts into the ions is rapid and complete in relevant environmental and physiological media and therefore no systemic exposure to the salts as such occurs. Exposure to the non-common cations (Ca2+ and K+) does not influence the prediction of the (eco)-toxicity because both elements are abundantly present in natural environments and emissions from these salts do not significantly increase the exposure concentration for calcium and potassium. Moreover, calcium and potassium are major essential element for living organisms.Further information is included as attachment in section 13 of IUCLID.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Dose descriptor:
NOEL
Effect level:
>= 674 mg/kg bw/day
Based on:
act. ingr.
Remarks:
dihydrogenphosphite anion
Sex:
male/female
Basis for effect level:
clinical signs
body weight and weight gain
food consumption and compound intake
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
reproductive function (oestrous cycle)
reproductive function (sperm measures)
reproductive performance
Key result
Dose descriptor:
NOEL
Effect level:
>= 841 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
body weight and weight gain
food consumption and compound intake
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
reproductive function (oestrous cycle)
reproductive function (sperm measures)
reproductive performance
Dose descriptor:
NOEL
Generation:
F1
Effect level:
>= 674 mg/kg bw/day
Based on:
act. ingr.
Remarks:
dihydrogenphosphite anion
Sex:
male/female
Basis for effect level:
sexual maturation
clinical signs
mortality
body weight and weight gain
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
Key result
Dose descriptor:
NOEL
Generation:
F1
Effect level:
>= 841 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
sexual maturation
clinical signs
mortality
body weight and weight gain
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
Reproductive effects observed:
not specified
Conclusions:
NOEL: ≥ 841 mg Ca(H2PO3)2 /kg bw/dayResults indicate that KH2PO3/K2HPO3 did not induce signs of toxicity at 1000 mg/kg bw/day. Values were recalculated for Ca(H2PO3)2 based on the assumption that the phosphite anion is the active ingredient reposonsible for the effects, resulting in a predicted NOEL of ≥ 841 mg Ca(H2PO3)2 /kg bw/day.
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
841 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In the assessment of calcium dihydrogenphosphite (Ca(H2PO3)2, CAS 13780-04-6), a read-across approach is followed based on the information available for potassium phosphonate (KH2PO3/K2HPO3 EC 915-179-9). This read-across strategy is based on the hypothesis that the phosphite anion is the driver for the ecotoxicological and toxicological effects of both salts.The read-across hypothesis is justified by the immediate dissociation of calcium dihydrogenphosphate and potassium phosphonate upon dissolution in aqueous media. Both phosphite salts are highly soluble (>200 g/L) and are only present in their dissociated form in solution, i.e. the calcium or potassium cation and the phosphite anion. The transformation of the salts into the ions is rapid and complete in relevant environmental and physiological media and therefore no systemic exposure to the salts as such occurs. Exposure to the non-common cations (Ca2+ and K+) does not influence the prediction of the (eco)-toxicity because both elements are abundantly present in natural environments and emissions from these salts do not significantly increase the exposure concentration for calcium and potassium. Moreover, calcium and potassium are major essential element for living organisms.Further information is included as attachment in section 13 of IUCLID.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Dose descriptor:
NOEL
Effect level:
>= 674 mg/kg bw/day (actual dose received)
Based on:
act. ingr.
Remarks:
dihydrogenphosphite anion
Basis for effect level:
other: developmental toxicity
Key result
Dose descriptor:
NOEL
Effect level:
>= 841 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: developmental toxicity
Dose descriptor:
NOEL
Effect level:
>= 674 mg/kg bw/day
Based on:
act. ingr.
Remarks:
dihydrogenphosphite anion
Basis for effect level:
other: teratogenicity
Key result
Dose descriptor:
NOEL
Effect level:
>= 841 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: teratogenicity
Abnormalities:
not specified
Developmental effects observed:
not specified
Conclusions:
NOEL: ≥ 841 mg Ca(H2PO3)2 /kg bw/dayResults indicate that KH2PO3/K2HPO3 did not induce signs of toxicity at 1000 mg/kg bw/day. Values were recalculated for Ca(H2PO3)2 based on the assumption that the phosphite anion is the active ingredient reposonsible for the effects, resulting in a predicted NOEL of ≥ 841 mg Ca(H2PO3)2 /kg bw/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
841 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data give no indication that calcium dihydrogenphosphite is toxic for reproduction.

Classification is not warranted under CLP regulation (EC 1272/2008).

Additional information