Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records
Reference
Endpoint:
genetic toxicity in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

According to Annex XI section 1 of the REACH Regulation, the study does not need to be conducted when testing does not appear scientifically necessary. Annex XI considers the opportunity of evaluating historical human data.

As documented in the "BIOPESTICIDES REGISTRATION ACTION DOCUMENT" for Quillaja Saponaria, the U. S. Environmental Protection Agency (http://www.epa.gov/opp00001/chem_search/reg_actions/registration/decision_PC-097095_11-Sep-09.pdf) considered Quillaja Saponaria as not mutagenic and not related to any known classes of mutagens since humans are regularly exposed to Quillaja saponins via their use as an FDA-approved flavoring agent and food additive without any reported adverse effects on human health.

Chronic feeding studies have shown that Quillaja Saponaria is not carcinogenic to mice and rats even when fed up to levels of 2200 mg/kg bw. For a long time Quillaja saponaria extracts are widely used as foaming agents in beverages and emulsifiers in foods with no report of any adverse effects. In soft drinks Quillaja extracts are used at levels of 100-500 mg/kg.

Quillaja is used in cocktail mixes and as emulsifiers in foods such as baked goods, candies, frozen dairy products, gelatine, and puddings. Other saponins are widely used in commonly consumed human food, flavoring, herbs, and spices also with no report of any adverse effects.

The WHO /FAO Expert Committee on Food Additives established an ADI (Acceptable Daily Intake) for Quillaja extracts of up to 5 mg/kg (http://www.inchem.org/documents/jecfa/jecmono/v48je03.htm#4.0).

The General Standard for Food Additives (GSFA) of the Codex Alimentarius Commission lists Quillaja Saponaria as suitable for use as foaming agent in water-based flavoured drinks, including sport, energy or electrolyte drinks with a maximum use level of 500 mg/kg (Codex Alimentarius Commission, Joint/WHO Food Standards Programme, Codex Committee on Food Additives and Contaminants, Thirty-seventh Session, The Hague, The Netherlands, 25-29 April 2005, CX/FAC 05/37/9).

Quillaja Saponaria extract are generally considered as safe (GRAS) by the Food and Drug Administration (FDA) of the United States (FEMA GRAS number 2973).

Based on the existing human data and human experience with Quillaja Saponaria the substance is not mutagenic nor carcinogenic. Therefore testing for mutagenicity is scientifically unjustified.

Justification for classification or non-classification

As outlined above, no classification and subsequent labelling of Quillaja saponaria ext. for mutagenicity is required.