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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral: rat and mouse LD50 4000 mg/kg. Reliability = 2

Inhalation: No study available

Dermal: No study available

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Acute oral toxicity test in the rat at 4000 mg/kg
GLP compliance:
no
Test type:
other: acute oral toxicity
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system 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:
other: none reported
Gross pathology:
none reported

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

Interpretation of results:
GHS criteria not met
Conclusions:
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
Value:
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

Several studies in multiple species and via multiple routes of exposure have demonstrated low acute toxicity of xylitol. Xylitol does not show acute toxicological effects when it is administered by oral, intraperietoneal, subcutaneous or intravenous routes. The LD50 ranges from greater than 2000 mg/kg bw for oral toxicity (greater than 4000 mg/kg bw in mice and rats and over 2000 mg/kg bw in rabbits).

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 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 EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.