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Diss Factsheets

Administrative data

Description of key information

LD50 Acute Oral rat ≥5000 mg betaine hydrochloride /kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute 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
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The defined LD50-value for betaine is 11179 mg/kg (female/male), and it can be considered as practically nontoxic.
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 stomache, betaine hydrochloride will be completely dissociated and there will be no distinction between toxicokinetics of betaine administered as such or as betaine hydrochloride. Therefore, it is concluded that the LD50-value for betaine hydrochloride is also well above of the limit for classification (5000 mg/kg bw).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Oral acute toxicity

The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:

Oral (mg/kg bodyweight)

Category 1: ATE ≤ 5

Category 2: 5 < ATE≤ 50

Category 3: 50 < ATE≤ 300

Category 4: 300 < ATE≤ 2 000

Results for betaine hydrochloride suggest the acute toxicity estimate (ATE) to be greater than 5000 mg/kg body weight.