Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 March 2009 to 14 April 2009 (in-life phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions.

Data source

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

Materials and methods

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

Test material

Constituent 1
Reference substance name:
MTDID 10078
IUPAC Name:
MTDID 10078
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report: MTDID 10078
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Analytical purity: 91.9%
- Purity test date: 2/17/2009
- Lot/batch no.: 140499-21/8
- Expiration date of the lot/batch: 31 December 2011
- Storage condition of test material: At room temperature in the dark

Test animals

Species:
rat
Strain:
other: Wistar Crl:WI (Han) (outbred, SPF-Quality)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approximately 9-10 weeks old
- Weight at study initiation: 156-190 grams (On Day 1)
- Fasting period before study: Animals were fasted overnight prior to dosing and until 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm)
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiaten GmbH, Soest, Germany) ad libitum.
- Water (e.g. ad libitum): Tap water ad litibum
- Acclimation period: At least 5 days before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21.0
- Humidity (%): 41-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 24 March 2009 To: 14 April 2009

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.227 mL/kg body weight
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data
Doses:
300 and 2000 mg/kg body weight
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?)

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occured.
Clinical signs:
Hunched posture and/or piloerection was noted in all animals on Days 1 and/or 2.
Body weight:
Body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
other: Based on the results of the test article falls into GHS Acute Oral Toxicity Category 5 (>2000 mg/kg to
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Based on the results of the study, the oral LD50 of the test article is greater than 2000 mg/kg.
Executive summary:

The acute oral toxicity of the test article was evaluated in female Wistar rats. This study was performed in compliance with OECD GLP (1997). The study design was based on OECD 423 (2001), EC 440/2008, B1, EPA OPPTS 870.1100 (2002) and JMAFF guidelines (2000) including recent partial revisions. The test article was dosed as received. One group (3 females) received 300 mg/kg test article via oral gavage. In a stepwise procedure two additional groups (3 females each) received 2000 mg/kg test article via oral gavage. The rats were observed immediately and at 2, and 4 hours postdose and then once daily for 14 days. Body weights were recorded pretest, weekly, and at termination. All animals were examined for gross pathology. All animals survived. Hunched posture and/or piloerection were noted in all animals on Days 1 and/or 2. There were no abnormal body weight changes or necropsy findings in any animals. Based on the results of this study, the oral LD50 of the test article is greater than 2000 mg/kg.