Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 days
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern GLP study conducted in accordance with modern guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch number E0011-039E

Test animals

Species:
rat
Strain:
other: albino
Sex:
female
Details on test animals and environmental conditions:
Six female albino rats of approximately nine weeks of age were used in the study. They were individually housed during the study. The animal was maintained on a 12-hour light/dark cycle (06:00 to 18:00). Mean daily temperatures and humidities ranged from 20.8 to 21.4 deg C and 34 to 44% respectively.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bodyweight
Doses:
2,000 mg/kg bodyweight (limit test)
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: 15 minutes, 1, 2 and 4 hours after dosing, and daily thereafter.
- Frequency of weighing: Day of dosing (Day 0), Day 7 and Day 14.
- Necropsy of survivors performed: yes/no Yes.
Statistics:
Not performed. There were no deaths in the study.

Results and discussion

Effect levels
Remarks on result:
other: There were no deaths
Mortality:
There were no deaths
Clinical signs:
No clinical signs were observed, except for a transient decrease in size of faeces and/or decreased defecation in one animal during the first two days after dosing. This may have been due to the fasting period prior to dosing.
Body weight:
There were no remarkable bodyweight changes
Gross pathology:
There were no gross pathology findings.

Applicant's summary and conclusion

Conclusions:
The test material caused no mortality or signs of toxicity in this study. The acute oral LD50 of the test material in albino rats is greater than 2,000 mg/kg bodyweight.
Executive summary:

An acute oral toxcity study (acute toxic class method - limit test) of was conducted in fasted female albino rats using a dose of 2,000 mg of test material per kg bodyweight. The test material was dissolved in corn oil and administered at a dosing volume of 10 ml/kg. Three animals were dosed and, when no deaths were observed after 48 hours, a confirmatory test using a further three females was conducted. In each case, animals were maintained for a 14 -day observation period.

This GLP study was conducted in accordance with OECD Test Guideline 423.

No animals died during the study and no signs of toxicity were observed in-life or at necropsy. The acute oral LD50 of the test material in albino rats is concluded to be >2,000 mg/kg bodyweight.