Reaction mass of 1,4:3,6-dianhydro-D-glucitol monooleate and 1,4:3,6-dianhydro-D-glucitol dioleate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4:3,6-dianhydro-D-glucitol

EC Number:

211-492-3

EC Name:

1,4:3,6-dianhydro-D-glucitol

Cas Number:

652-67-5

Molecular formula:

C6H10O4

IUPAC Name:

1,4:3,6-dianhydro-D-glucitol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA-CREDO, 69592 L’Arbresle, France
- Age at study initiation: 5 weeks
- Weight at study initiation: 146.6 – 160.9 g for males, 124.1 – 133.6 g for females
- Fasting period before study: 18 h
- Housing: 2 animals per cage, in Makrolon cages (37.5 x 23.5 x 16 cm), stainless streel grid lid, sawdust bedding
- Diet: ad libitum A04C maintenance diets pellets, UAR – 9130 Villemoisson / Orge – France
- Water: ad libitum potable water, Chateau’eau SA, 59110 La Madeleine, France
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): >12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg bw

Doses:

2 g/kg bw

No. of animals per sex per dose:

6

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were carefully observed before and just after dosing, 1 hour and 3 hours after administration. After that animals were observed daily. Animals were weighted on day 0, day 3, day 7, day 10 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Feed and water consumption

Statistics:

Differences in the clinical observations and the observations at necropsy were analyzed using the chi-square test. Means and standard types were calculated with Excel for the following parameters: body weight, feed and water consumptions. Student t-test was used to compare the body weights between the 2 groups.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

No test item related clinical signs were observed. Animal behavior of treated animals was considered as normal.

Body weight:

- Male, control group, day 14: 277.1 - 300.6 g
- Male, test group, day 14: 272.6 - 301.3 g
- Female, control group, day 14: 185.0 - 206.0 g
- Female, test group, day 14: 183.2 - 224.4 g

Gross pathology:

No treatment related abnormalities were observed.

Other findings:

- Other observations: feed and water consumption were comparable between test group and control group

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met