L-arabinose

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

repeated dose toxicity: inhalation, other

Type of information:

other: Expert Statement

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Expert Statement

Justification for type of information:

An Intake Assessment was performed to estimate the average daily intake of L-Arabinose (L-ARA) with a habitual diet. Three main foodstuffs were considered, complemented by the intake of L-Arabinose by gum arabic as food additive. A rough estimate of the dietary L-Arabinose consumption could be calculated. The highest contributor to the L-Arabinose intake in humans is gum arabic, which is widely used as food additive. The range of L-Arabinose intake by consumption of gum arabic as food additive varies from 0.61 to 25.1 g for adolescents and 0.37 g to 19.8 g for adults. Natural plant based foodstuffs contain L-ARA as a part of the NSP fraction, which at least to some extend are broken down to monomeric L-ARA in the GI-tract. Through the intake data of three main foodstuffs: apples, pears and beans, they provide evidence of a substantial L-ARA consumption with the habitual diet. Dried beans may contribute substantially to the L-arabinose intake. With this high daily intake of L-ARA in polysaccharide bound form and partial hydrolysis in the GI tract in human, thereof it can be concluded that safety of L-ARA is substantiated. As there is no evidence of any adverse effect of this ubiquitous pentose, which is part of the human food chain, no further animal safety testing is necessary for REACH registration of L-ARA.
According to REGULATION (EC) No 1907/2006, Annex VIII/IX, testing for repeated dose toxicity (section 8.6) may be omitted, if testing does not appear scientifically necessary. According to Annex XI section 1.1.2, adequate data on human health properties should be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13 (3) if the following conditions are met: 1) adequacy for the purpose of classification and labelling and/or risk assessment; 2) adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3); 3) exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3); and 4) adequate and reliable documentation is provided. In addition and in accordance with Annex XI section 1.2, relevant independent sources of information are available, leading to the conclusion that the substance has not a particular dangerous property. Therefore, further testing on vertebrate animals for that property shall be omitted where adequate and reliable data for the absence of a particular dangerous property is available.

Based on adequate data from the Intake Assessment, a history of safe use of L-Arabinose in humans can be concluded. There is no evidence of any adverse effect of this ubiquitous pentose, which is part of the human food chain. In the light of this habitual exposure to L-Arabinose, the safety of L-Arabinose is evident and additional animal trials to study repeated dose toxicity including reproductive and developmental toxicity is unjustified. Also from an animal welfare perspective, unnecessary animal trials should be avoided when there is no indication for toxicity.

Data source

Reference

Reference Type:

other: Expert statement

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Principles of method if other than guideline:

Expert Statement

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

L-arabinose

EC Number:

226-214-6

EC Name:

L-arabinose

Cas Number:

5328-37-0

Molecular formula:

C5H10O5

IUPAC Name:

L-arabinose

Test material form:

solid

Results and discussion

Effect levels

Key result

Remarks on result:

not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Key result

Critical effects observed:

no