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Administrative data

Description of key information

one available study on acute toxicity, orale route present,

no study on acute toxicity, inhalative route present

no study on acute toxicity, dermal route present, but two studies for repeated dose toxicity, subcutaneous route present. Additional information is taken from skin irritation data.

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
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
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
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
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
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
16 000 mg/kg bw
Quality of whole database:
study performed according to acceptable Guideline, other information (repeated dose toxicity data) support conclusion

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
no study available. due to physico chemical properties, no study needed.

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
other: discussion of available information
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: adapting information from repeated dose toxicity studies
Reason / purpose for cross-reference:
reference to other study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
information from referenced studies is assessed and used to adapt data requirement.
GLP compliance:
no
Test type:
other: details given in referenced study summaries
Specific details on test material used for the study:
details given in referenced study summaries
Type of coverage:
other: details given in referenced study summaries
Vehicle:
other: details given in referenced study summaries
Details on dermal exposure:
details given in referenced study summaries
Duration of exposure:
details given in referenced study summaries
Doses:
details given in referenced study summaries
No. of animals per sex per dose:
details given in referenced study summaries
Details on study design:
details given in referenced study summaries
Statistics:
details given in referenced study summaries
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: species mouse
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 250 mg/kg bw
Based on:
test mat.
Remarks on result:
other: species dog
Mortality:
details given in referenced study summaries
Clinical signs:
other: details given in referenced study summaries
Gross pathology:
details given in referenced study summaries
Other findings:
details given in referenced study summaries

No signs of toxicity were noted by subcutaneous route in mouse and dog.

This piece of evidence shows that systemic toxicity does not occur, when the substance is administered under the skin. Therefore the results represent absence of effects under the assumption of 100 % dermal absorption.

Interpretation of results:
other:
Conclusions:
No signs of toxicity were noted by subcutaneous route in mouse and dog.
the results represent absence of effects under the assumption of 100 % dermal absorption.
The stated LD50 is valid for the species mouse.
Endpoint:
acute toxicity: dermal
Type of information:
other: discussion of available information
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: adapting information from repeated dose toxicity studies
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
information from referenced studies is assessed and used to adapt data requirement.
GLP compliance:
no
Test type:
other: details given in referenced study summaries
Specific details on test material used for the study:
details given in referenced study summaries
Species:
other: details given in referenced study summaries
Strain:
other: details given in referenced study summaries
Details on test animals or test system and environmental conditions:
details given in referenced study summaries
Type of coverage:
other: details given in referenced study summaries
Vehicle:
other: details given in referenced study summaries
Details on dermal exposure:
details given in referenced study summaries
Duration of exposure:
details given in referenced study summaries
Doses:
details given in referenced study summaries
No. of animals per sex per dose:
details given in referenced study summaries
Details on study design:
details given in referenced study summaries
Statistics:
details given in referenced study summaries
Sex:
male/female
Dose descriptor:
other: total dose
Effect level:
500 other: mg
Based on:
test mat.
Remarks on result:
other: no signs of toxicity noted
Mortality:
details given in referenced study summaries
Clinical signs:
other: details given in referenced study summaries
Gross pathology:
details given in referenced study summaries
Other findings:
details given in referenced study summaries

No signs of toxicity or other significant effects were noted when Trehalose was administered to the skin of rabbits in order to determine the skin irritation potential of the substance. In addition to information from repeated dose toxicity studies, subcutaneous route, this piece of information demonstrates the absence of toxic effects on the skin.

Interpretation of results:
study cannot be used for classification
Conclusions:
No signs of toxicity were noted during the test on skin irritation properties.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw
Quality of whole database:
two studies on repeated dose toxicity, subcutaneous route available and assessed reliable. Additionally observations from irritation testing support conclusion.

Additional information

Justification for classification or non-classification

In accordance with Regulation EC No. 1272/2008, the information on acute toxicity by the oral route is conclusive. The provided information is conclusive but not sufficient for classification.

Taking together all evidence on toxicity by the dermal route, the information is conclusive but not sufficient for classification.

Taking together all evidence on toxicity by inhalation, the information is conclusive but not sufficient for classification.