Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): DIOLO
- Substance type: Organic
- Physical state: Yellow powder
- Analytical purity: >90%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: DEPRE breeding centre (Z.I. malitorne - B.P. 70 - 3, -rue Joliot-Curie - 18230 SAINT DOULCHARD - FRANCE)
- Age at study initiation: Over 6 weeks at the time of administration
- Weight at study initiation: 154.6 ± 5.7 for female; and 170 ± 6.7 of male
- Fasting period before study: overnight
- Housing: Rats were housed in groups of five animals, males and females separated, were kept in standard size cages, on dust-free radiation sterilised white whood shavings as bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days before treatment, in the area where the study had taken place

ENVIRONMENTAL CONDITIONS
- Temperature (°C): air-conditioned between 19 an 23°C
- Humidity (%): constant relative humidity between 45 and 65%
- Air changes (per hr): ten time per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: The dose administered was expressed in mg/kg and adjusted to the weight of the animal as determined immediately before administration.
- Amount of vehicle (if gavage): max 10 mL/kg
Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were examined twice on the day of treatment, then daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and macroscopically examined.

Results and discussion

Preliminary study:
Test substance was expected to be non-toxic by opral route, thus no preliminary study had been carried out.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study
Clinical signs:
No clinical signs were observed during the course of the study
Body weight:
Mean weight gain in treated animals was normal when compared with strain data
Gross pathology:
Macroscopic examination at the end of the observation period did not reveal any teatment-related gross alteration
Other findings:
No organ or tissiue gross findings were seen at necroscopsy

Any other information on results incl. tables

Dose applied, mean body weights and mortality or rats male and female:

   Dose (mg(kg)        Mean body weight (g) on day Mortality (per 5 animals)
Sex  0  7  14
 Males  2000  170.7  236.8  287.0  0/5
 Female  2000  154.6  194.1  222.2  0/5

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of diol acetate is less than the limit for classification as harmful.
Executive summary:

Under the experimental conditions adopted, oral administration of the test substance DIOLO at dose of 2000 mg/kg caused no mortality and did not require euthanasia during 14 -day period, in the male or female Sprague-Dawley Rat.