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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

NOAEL oral rat subacute ≥ 7567 mg betaine hydrochloride/kg bw/day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
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 betaine hydrochloride (C5H12NO2.Cl, CAS 590-46-5), a read-across approach is followed based on the information available for betaine (C5H11NO2, CAS 107-43-7). This read-across strategy is based on the hypothesis that the betaine moiety is the driver for the ecotoxicological and toxicological effects of both substances.
The read-across hypothesis is justified by the immediate dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media. Both betaine and betaine hydrochloride are highly soluble (>400 g/L). Exposure to the non-common cations (H+ and Cl-) does not influence the prediction of the (eco)-toxicity at relevant concentrations because both elements are abundantly present in natural environments and the human body and emissions from this substance do not significantly increase their overall exposure concentration.

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
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
hepatocellular vacuolation
Histopathological findings: neoplastic:
no effects observed
Dose descriptor:
NOAEL
Effect level:
>= 7 567 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: see 'Remark'
Critical effects observed:
not specified

No other histopathological effects other than slight to moderate hepatocellular vacuolation in study groups (1, 2 and 5% groups) which were totally reversible.

Conclusions:
NOAEL for betaine hydrochloride: 7567 mg/kg bw/day (nominal) (5% test substance in diet)

Results for betaine indicate a NOAEL of 5771 mg/kg bw/day, based on high tolerance of test substance and reversibility of the slight hepatocellular vacuolation effects. Therefore it can be concluded that betaine is tolerated at very high levels and its effects are reversible.
According to a read-across approach based on the rapid dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media, it is concluded that the results for betaine are also applicable to betaine hydrochloride. After passage through the stomach, betaine hydrochloride will be completely dissociated and there will be no distinction between toxicokinetics of betaine administered as such or as betaine hydrochloride. Molecular weight conversion of the NOEAEL of 5771 mg/kg bw/day for betaine to betaine hydrochloride results in a NOAEL of 7567 mg/kg bw/day.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
7 567 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Repeated oral toxicity

The substance is not classified orally toxic because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008 on repeated exposure:

No oral repeated toxicity on organs was predicted up to 7567 mg/kg bw/day for betaine hydrochloride.