Trehalose

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trehalose

EC Number:

202-739-6

EC Name:

Trehalose

Cas Number:

99-20-7

Molecular formula:

C12H22O11

IUPAC Name:

trehalose

Test material form:

solid: crystalline

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 931129
- Expiration date of the lot/batch:28 May 1995
- Purity test date: not specified

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: assumed stable and soluble
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not expected

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

FORM AS APPLIED IN THE TEST (if different from that of starting material)
not different

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Females (if applicable) nulliparous and non-pregnant: [yes/no] not specified
- Age at study initiation: 4-7 weeks
- Weight at study initiation: 95 - 114 g
- Fasting period before study: not specified
- Housing: in groups of up to 5 of same sex
- Diet (e.g. ad libitum): standard laboratory rodent diet ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 80 % w/v
- Amount of vehicle (if gavage): the formulated test substance was administered as two equal dosage volumes over a one hour period giving a total dose volume of 20 ml/kg bodyweight
- Justification for choice of vehicle: according to Guideline
- Lot/batch no. (if required): not relevant
- Purity: not relevant

MAXIMUM DOSE VOLUME APPLIED: see above

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

16 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations on day of administration: every 6 hours, then twice each day for the subsequent days.
weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Statistics:

none performed

Results and discussion

Preliminary study:

A preliminary study was carried to establish the feasability of administration of a dosage of 16 g/kg
bodyweight by dosing two male and two female rats at 16 g/kg bodyweight.
The results of the preliminary study indicated that the acute lethal oral dose to male and female rats
of Trehalose Crystals was greater than 16 g/kg bodyweight.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Piloerection was observed in all rats within five minutes of dosing and throughout the remainder of Day 1 and also at later intervals during the study. There were no other signs with the exception of soft to liquid faeces which was evident in one male dur

Gross pathology:

No macroscopic abnormalities were observed for animals killed on Day 15.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal oral dose to rats of Trehalose Crystals was found to be greater than 16 g/kg
bodyweight.

Executive summary:

A study was performed to assess the acute oral toxicity of Trehalose Crystals to the rat. The method

followed was that described in the OECD Guideline for Testing of Chemicals No. 401 "Acute Oral

Toxicity". Adopted: 24 February 1987.

A group of ten fasted rats (five males and five females) was given a total dose by oral gavage of the

test substance, formulated in distilled water, at a dose level of 16.0 g/kg bodyweight. All animals

were killed and examined macroscopically on Day 15, the end of the observation period.

There were no deaths. Clinical signs of reaction to treatment were limited to piloerection and soft

to liquid faeces. Recovery was complete in all instances by Day 4.

A slightly low bodyweight gain was recorded for one female on Day 8; this rat achieved the

anticipated gain on Day 15. All other rats achieved satisfactory bodyweight gains throughout the

study.

No abnormalities were recorded at the macroscopic examination on Day 15.

The acute lethal oral dose to rats of Trehalose Crystals was found to be greater than 16 g/kg

bodyweight.