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Administrative data

Description of key information

Xylitol has been shown to have a very low order of toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment
Reason / purpose:
reference to same study
Principles of method if other than guideline:
Acute oral toxicity test with rat
GLP compliance:
no
Test type:
other:
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Adult Rats: weight at study initiation: 130-175 g; Age at study initiation: not reported
- Neonatal Rats: weight at study initiation: 6 - 9 g; Age at study initiation: not more than 24 hours old


Route of administration:
oral: gavage
Vehicle:
other: suspended in 5% gum acacia solution (with and without tracer dye)
Details on oral exposure:
DOSAGE PREPARATION: Adult rats: The compound was ground in a mortar, suspended in 5% gum acacia solution and administered orally; Neonatal rats: The compound was suspended in 5% gum acacia solution containing a tracer dye and administered orally with a 20 gauge needle.

Doses:
highest dose tested 4000 mg/kg
No. of animals per sex per dose:
10 per dose level
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: daily
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
none reported

No mortality at highest dose tested (4000 mg/kg).

Conclusions:
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
LD50 > 4000 mg/kg
Executive summary:

The adult and neonatal rat oral LD50 of the test substance was determined to be greater than 4000 mg/kg/body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
4 000 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

Xylitol has been shown to have very low order of toxicity with an LD50 from 2000 mg/kg to greater than 4000 mg/kg bw for oral toxicity in multiple species.


Justification for selection of acute toxicity – oral endpoint
Scientifically valid study

Justification for classification or non-classification

Based on rat and mouse oral LD50s of > 4000 mg/kg, the substance does not need to be classified for acute oral toxicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Data lacking due to waiving arguments, so substance cannot be classified for acute inhalation or dermal toxicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.