Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River (UK) Ltd, Margate, Kent, UK- Age at study initiation: 8-12 weeks- Weight at study initiation: Males: 252-270g, females: 204-222g- Fasting period before study: overnight + 3-4 hours after dosing- Housing: solid-floor polypropylene cages furnished with woodflakes- Diet (e.g. ad libitum): With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.- Water (e.g. ad libitum): See above- Acclimation period: at least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19-23- Humidity (%): 49-70- Air changes (per hr):15- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
One dose by gavage, using a metal cannula attached to a graduated syringe
Doses:
Using all available information, 200 mg/kg bodywitht was selected as the starting dose. A group of three fasted females was treated with the starting dose. Based on the result from this dose level further groups of fasted animals were treated t a dose level of 200 mg/kg bodyweight.
No. of animals per sex per dose:
3 Females: 2000 mg/kg 3 Females + 3 males: 200 mg/kg
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations: ½, 1, 2, 4 hours after dosing and then once daily for 14 days.- Frequency of weighing: At day 0 (Day of dosing) + on day 7 +14.- Necropsy of survivors performed: Yes- Other examinations performed: clinical signs: Signs of systemic toxicity noted were hunched posture, lethargy, pilo-erection, decreased respiratory rate, laboured respiration and ataxia, developing on the day of dosing and lasting up to one day after dosing.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
500 - 1 000 mg/kg bw
Based on:
test mat.
Mortality:
Two animals treated with 2000 mg/kg were found dead.
Clinical signs:
Signs of systemic toxicity noted in animals treated with 200 mg/kg were hunched posture, lethargy, pilo-erection, decreased respiratory rate, laboured respiration, clonic convulsions, tonic convulsions, prostration, increased salivation, splayed gait and tiptoe gait, lasting up to five days after dosing.Hunched posture was noted in one male treated with 200 mg/kg two and four hours after dosing.
Body weight:
The surviving animals showed expected gains in bodyweight over the study period.
Gross pathology:
Abnormalties noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver, pale spleen and dark kidneys. Nor abnormalities were noted at necropsy of animals killed at the end of the study.

Applicant's summary and conclusion

Conclusions:
The acute oral LD50 of the test material, Fluorlacton, in the Sprague-Dawley CD strain rat was estimated as being in the range of 500 to 1000 mg/kg.
Executive summary:

Mortalities were noted at 2000 mg/kg bodyweight (2/3). No mortalities were noted at 200 mg/kg bodyweight.