Reaction mass of 3-O-acetyl-1,5-anhydro-4-butyl-2,4-dideoxy-2-methyl-D-xylitol and (2R,3S)-2-methyloctane-1,3-diyl diacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 22, 1979 - November 5, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

This information is used for read-across to Jessemal.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No details on test material, no purity, no details on environmental conditions.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Wistar-strain albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Suitable licensed dealer
- Age at study initiation: approx. 6 to 8 weeks
- Weight at study initiation: 200 - 238 g
- Fasting period before study: approx. 18 hours
- Housing: Animals were housed in galvanized cages with indirect bedding
- Diet: Free access to diet consisted of a growth and maintenance ration from a commercial producer
- Water: Free access to water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Individual doses, calculated on the basis of bodyweight, were administered using a stainless steel intragastric feeding needle.

Doses:

5000 mg/kg bodyweight

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: The animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6 and 24 hours after application and thereafter daily.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed, necropsied and subjected to complete gross necropsy, with all findings noted.
- Body weights: Individual body weights were recorded immediately before treatment and then on the 14th day of the observation period.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

Slight depression was oberserved among all animals at 3, 6 and 24 hours after application of the substance.

Body weight:

Normal bodyweight increases were observed on the 14th day of the observation period.

Gross pathology:

No gross changes were observed.

Applicant's summary and conclusion

Interpretation of results:

other: Not acutely orally toxic

Remarks:

according to EU CLP(EC No. 1272/2008 and its amendments)

Conclusions:

The acute oral toxicity test showed an LD50 of >5000 mg/kg bw

Executive summary:

In this study performed equivalent to OECD TG 401 guideline and GLP principles, 10 rats (5 males and 5 females) were administered to the substance at a dose level of 5000 mg/kg bw. No deaths occurred. Slight depression was oberserved among all animals at 3, 6 and 24 hours after application of the substance. Normal bodyweight increases were observed on the 14th day of the observation period. No gross changes were observed. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.