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:
2010
Report Date:
2010

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
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Stability under test conditions: The analytical data verify that the test item 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 GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: 8-12 weeks approximately
- Weight at study initiation: 170-207 g
- Fasting period before study: Food was withheld from the animals for approximately 16-24 h before administration of the test item, and they 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:
corn oil
Details on oral exposure:
Administration volume: 10 mL/kg bw

VEHICLE
The test substance was formulated in corn oil to yield a solution.
Doses:
2000 mg/kg bw (single dose)
No. of animals per sex per dose:
6 (3 animals per step)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily. The weight gain was checked weekly until the end of the study.
- Necropsy of survivors performed: yes
Statistics:
The LD50 value was estimated according to OECD TG 423 (2001).

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Remarks on result:
other: cut-off level according to OECD TG 423, Annex 2d
Mortality:
There were no deaths.
Clinical signs:
No clinical signs were observed
Body weight:
There were no toxicologically significant effects on body weight or body weight gain.
Gross pathology:
The necropsies performed at the end of the study revealed no particular findings.

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study according to the Acute Toxic Class Method (OECD TG 423) was performed on 6 female rats (3 per step), receiving each a single dose of 2000 mg/kg of the test item formulated in corn oil. No mortalities, no clinical signs, no effects on body weigth gain and no gross pathological findings were observed. The LD50 cut off of the test material was estimated from the flow chart of the OECD TG 423, Annex 2d, to be 5000 mg/kg bw.