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Carcinogenicity

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Description of key information

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Choline chloride was neither classified as mutagenic nor revealed any evidence in the available subacute, subchronic or chronic study, i.e. hyperplasia and/or pre-neoplastic lesions, for the classification as carcinogen. Hence, it does not need to be classified, neither according Regulation 1272/2008/EC nor Directive 67/548/EEC.

Additional information

According to REACH Annex X column 2, a carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:

– the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure; and

– the substance is classified as mutagen category 3 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

 

In the 2 year repeated dose toxicity study in rats (Shivapurkar N, 1986), no adverse effects were detected compared to control. In fact, although not statistically significant, Choline chloride treated animals developed less tumors than control animals. Also, no effects were seen regarding body weight gain, and the relative liver weight was also slightly, but not significantly decreased compared to control. This could be due to the fact that Choline chloride, which is also used as a feed additive, is an effective methyl donor, which does not require extensive metabolic pathways, which could possibly lead to additional liver damage due to hazardous degradation products. Hence, it is likely that CC does not only exhibit no adverse effects but also liver-protecting effects. Most likely effects for an increased liver weight can be (non)-neoplastic lesions, fatty liver or scar formation / cirrhosis due to necrosis already on only single cellular level, and also an increased requirement of metabolic enzymes. These effects are diminished by an additional gavage of Choline chloride.

 

Hence, there is no evidence from the 2 year repeated dose study, as well as in the available subacute and subchronic studies, that the substance is able to induce hyperplasia and/or pre-neoplastic lesions. Consequently, testing for carcinogenicity is not necessary and no additional testing needs to be proposed by the applicant.