Registration Dossier
Registration Dossier
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EC number: 231-665-7 | CAS number: 7681-38-1
Endpoint summary
Administrative data
Description of key information
No data specifically for sodium hydrogensulfate on repeated dose toxicity are available, thus read-across to sodium sulfate was performed. In a sub-acute oral toxicity study with sodium sulfate no adverse effects were noted, and the NOAEL (oral, rat) was established at 1000 mg/kg bw/day (Ceccatelli R., 2010 OECD 421 Main Study C79103).
Key value for chemical safety assessment
Additional information
Sodium hydrogensulfate is known to readily dissociate in water to yield hydrogensulfate and sulfate ions, which will be in a pH-dependent equilibrium. Thus, ingestion of both sulfate and hydrogensulfate will ultimately yield a ratio of both ionic species which is driven by the gastric pH more than the choice of which of the two substances was administered. For this reason, read-across from oral repeated dose toxicity data data generated for sodium sulfate to sodium hydrogensulfate is justified without restriction. The following data can be summarised for sodium sulfate for such read-across:
Sodium sulfate:
ORAL, RAT - 28 d
Ceccatelli R., 2010 OECD 421 Main Study C79103: The NOAEL 28 d (rat, oral) is 1000 mg/kg/day
This study is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item Sodium Sulfate to rats. Sodium Sulfate was administered in highly purified water as vehicle at dosages of 100, 300, and 1000 mg/kg body weight/day, and controls received the vehicle only. Sodium Sulfate was administered to male rats for at least 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. In absence of any effect the general NOEL (No Observed Effect Level) was established at 1000 mg/kg/day.
Moinuddin & Wing-Tsit Lee, 1960: the NOAEL 28 d (rat, oral) from this study is 2000 mg/kg/day
NOAEL (NOEL): The oral administration of sodium sulfate to rats by dietary admixture for a period of 4 weeks at a dose level of 0.88 mmol/kg feed did not result in any effects. A dosing regime of 8.64 mmol/kg feed on days 1-8, 17.28 mmol/kg feed on days 9-16, 34.56 mmol/kg feed on days 17-24 and 65.12 mmol/kg feed from day 25 for 4-6 days resulted in two slight cases of diarrhea that lasted for a day. At a dose level of 138 mmol/kg feed one rat showed diarrhea on 4 different days (3 consecutive days) in the middle of the feeding period. At the top dose the food contained around 2% sodium sulfate based on which the NOAEL was calculated to be around 2000 mg/kg bw/day.
ORAL, RAT - 28 d and 27/44 week
A clear NOAEL cannot be derived from the available data. Tentatively a chronic NOAEL of >= 320 mg/kg/day may be deduced from a 27 / 44 week study and a sub-chronic NOAEL of 2000 mg/kg from a 28 day study in rats. Ruminating animals are at risk at much lower levels because of the potential formation of sulfide in the rumen. Since this substance has no discernable systemic toxicity, the tentative chronic NOAEL of >= 320 mg/kg in rats would seem to provide a reasonable margin of safety compared to the estimated daily intake of 453 mg/person/day or around 6.5 to 7.5 mg/kg/day
DERMAL
Based on a lack of any quantitatively relevant dermal absorption for this substance, this study requirement should be waived. Route-to-route extrapolation from avalable oral data is not considered to be restricted.
INHALATION
Based on a lack of any quantitatively inhalation exposure because of particle size considerations and the low dustiness of the substance, relevant inhakation exposure of this substance can be ruled out, which is why this study requirement should be waived. In addition, route-to-route extrapolation from avalable oral data is not considered to be restricted.
Justification for classification or non-classification
Based on read-across from sodium sulfate (NOAEL oral, rat=1000 mg/kg bw/day Ceccatelli R., 2010), sodium hydrogensulfate does not require classification for repeated dose toxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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