1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study conducted between Januray 1982 and April 1982.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: No data

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The rats were divided into four groups, each composed of 10 males and 10 females. Three dose levels of the analyte were administered (3, 6 or 12 g/kg), based on the maximum physical intake capacity of rats as determined by previous experimentation. As a control , one group was given 4 ml/100 g (weight) of 5% gum arabic, the same quantity as the group that received the maximum analyte dosage.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol

EC Number:

402-950-5

EC Name:

1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol

Cas Number:

87826-41-3

Molecular formula:

C22 H26 O6

IUPAC Name:

(1R)-1-[(4R,4aR,8aS)-2,6-bis(4-methylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Details on test material:

- Name of test material (as cited in study report): GEL ALL MD
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:

rat

Strain:

other: SLo Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shizuoka Prefecture Experimental Animal Agricultural Cooperative Association (Nokyo)
- Age at study initiation: 7 weeks
- Weight at study initiation: 240 grams for males and 180 grams for females
- Fasting period before study: 15 to 17 hours
- Housing: Plastic cages (Aircon B from Clea Japan, Inc) with wood shavings on the floor of the cages
- Diet (e.g. ad libitum): The rats were provided unlimited quantities of feed ("MF Rat Feed" from Oriental Yeast Co. Ltd)
- Water (e.g. ad libitum): The rats were provided unlimited quantities of water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 + 1°C
- Humidity (%): 60 + 10%
- Air changes (per hr): 12 changes of air per hour

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Suspension in 5 % gum arabic

Doses:

Three dose levels of the analyte were administered (3, 6 or 12 g/kg), based on the maximum physical intake capacity of rats as determined by previous experimentation. As a control group , one group was given 4 mL/100 g (weight) of 5 % gum arabic, the same quantity as the group that received the maximum analyte dosage.

No. of animals per sex per dose:

10 males and 10 female per dose group.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: The general condition and health condition of the rats were observed for 7 days after administration. The animals weight was measured every day for 7 daya after administration.
- Necropsy of survivors performed: yes - all the animals were dissected after the end of the 7 days, and observations were made of their various organs.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 12 other: g/kg bw

Based on:

test mat.

Mortality:

No cases of deaths occurred in any of the test groups.

Clinical signs:

other: Males: No noteworthy toxic effects were observed in any of the test groups, although there was a temporary decrease in spontaneous exercise and a slight pilometer reflex after administration of the analyte. Females: As was true with the male rats, there

Gross pathology:

No abnormalities were observed during dissection.

Other findings:

Males:
There were no observations of unusual appearance or behavior in any of the test groups throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The analyte test material was administered suspended in 5 % gum arabic by gavage to SLo Wistar rats at the following dose levels:

3, 6 or 12 g/kg

The LD50 was determined to be >12 g/kg.

Executive summary:

After one week of acclimatisation, experiments were carried out on 7-week old rats with average bodyweights of 240 grams for males and 180 grams for females.

The rats were divided into four groups, each composed of 10 males and 10 females.

Three dose levels of the analyte were administered (3, 6 or 12 g/kg), based on the maximum physical intake capacity of rats as determined by previous experimentation. As a control group , one group was given 4 ml/100 g (weight) of 5% gum arabic, the same quantity as the group that received the maximum analyte dosage.

All of the animals were dissected after the end of the 7 days and observations were made of their various organs.

No cases of deaths occurred in any of the test groups.

Males:

No noteworthy toxic effects were observed in any of the test groups, although there was a temporary decrease in spontaneous exercise and a slight pilometer reflex after administration of the analyte.

Females:

As was true with the male rats, there were no toxic effects observed in any of the test groups, although there was the same temporary decrease in spontaneous exercise and slight pilometer reflex.

Weight gain trends were normal.

No abnormalities were observed during dissection.

There were no observations of unusual appearance or behavior in any of the test groups throughout the observation period.

The LD50 was determined to be >12 g/kg.