Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Dec 2008 to 9 Mar 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17th December 2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed

Test animals

Species:
rat
Strain:
other: Crl: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Atsugi Breeding Center, Charles River Laboratories Japan, Inc.
- Age at study initiation: 8 weeks
- Weight at study initiation: 197 - 204 g
- Fasting period before study: 16 h
- Housing: two animals per cage during the quarantine/acclimation period, afterwards one animal per cage in bracket-type stainless-steel wire mesh cages
- Diet: pelleted diet CRF-1 (Oriental Yeast Co., Ltd., Lot No.: 080904), ad libitum (4 h after exposure)
- Water: tap water ad libitum
- Acclimation period: approximately 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: December 24, 2008 (first step), December 26, 2008 (second step) To: January 7, 2009 (first step), January 9, 2009 (second step)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Lot/batch no.: PEM1838 (Wako Pure Chemical Industries Ltd.)

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Since the acute oral toxicity of the test article was expected to be extremely low, the starting dose level was set at 2000 mg/kg bw.
Doses:
2000 mg/kg bw (first and second step)
No. of animals per sex per dose:
first step: 3females
second step: 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality, clinical signs, external appearance, nutritional condition, posture, behavior and excrement were recorded first 6 h after administration (from immediately to 5 min, up to 15 min, 30 min, 1 h, 2 h, 4 h and 6 h after administration), and then once daily for 14 days. Body weight was measured on day 0 (immidiately before dosing) and on days 1, 3, 7 and 14 after administration.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology
Statistics:
Mean values and standard errors were calculated.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
Body weight and body weight gain were unremarkable.

Gross pathology:
Animals sacrificed at the end of the post-treatment observation period showed no evidence of test-substance related grossly visible organ lesions.

Any other information on results incl. tables

Table 1: Summary acute oral toxicity in rats

Dose step

Dose level

(mg/kg)

Dose concentration (mg/mL)

Dose volume

(mL/kg body weight)

Sex

Number of animals

Clinical signs/Mortality

First

2000

400

5

Female

3

0/0/3

Second

2000

400

5

Female

3

0/0/3

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
In this acute oral toxicity study performed in rats a LD50 value of > 2000 mg/kg bw was determined.