Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Stability under test conditions: The analytical data verify that the test compound formulations are stable at room temperature for at least 2 hours.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: HsdCpb:Wu
- Source: Harlan/Winkelmann GmbH, 33178 Borchen, Germany
- Age at study initiation: 10-12 weeks approximately
- Weight at study initiation: 157-186 g
- Fasting period before study: Food was withheld from the animals for approximately 16-24 h before administration of the test item, and animals were fed again approximately 2-4 h after administration.
- Housing: The animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding.
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: acetone/corn oil 1/10
Details on oral exposure:
- Administration volume: 10 mL/kg bw
- Concentration in vehicle: The test substance was formulated in acetone / corn oil 1/10 (test compound + 1 ml acetone ad 10 ml with corn oil)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (3 for 1st and 3 for 2nd testing)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations: Deaths and overt signs of toxicity were recorded repeated times on day of dosing and daily for 14 days. Bodyweights were recorded on the day of dosing and on days 7 and 14. At the end of the study all animals were subject to gross necropsy, macroscopic abnormalities were recorded, no tissues were retained.
Statistics:
The LD50 value was estimated according to OECD TG 423 (2001).

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
A dose of 2000 mg/kg bw was tolerated by female rats without mortalities.
Clinical signs:
No clinical signs were observed.
Body weight:
There were no toxicological effects on body weight or body weight gain.
Gross pathology:
No gross pathology findings.

Applicant's summary and conclusion

Executive summary:

In an acute oral toxicity study according to OECD TG 423 female rats were given a limit dose of 2000 mg/kg bw. No mortalities, no clinical signs, no effects on weight gain and no gross pathological findings were observed. The LD50 for the test substance was therefore > 2000 mg/kg bw.