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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26/07/2010-19/08/2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
other: Commission regulation 440/2008, L142, Annex Part B
Qualifier:
according to guideline
Guideline:
other: EPA OPPTS 870.1000 (Acute Toxicity testing background)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
ethyl 6-(3-chloro-2-fluorobenzyl)-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate
EC Number:
638-800-2
Cas Number:
949465-91-2
Molecular formula:
C25H27ClFNO5
IUPAC Name:
ethyl 6-(3-chloro-2-fluorobenzyl)-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: Animals N. 1-3, step 1: 153-180 g; Animals N. 4-6, step 2: 152-170 g
- Housing: Full-barrier in an air-conditioned room
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55+/- 10%
- Air changes (per hr): 10 x/ hour
- Photoperiod (hrs dark / hrs light): Artificial light, 12/ 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Doses:
2000 mg/kg bw
The test item was suspended in a veichel (Cottonseed oil) at a concentration of 0.4 g/ml and administered at a dose V of 5 mL/kg.
No. of animals per sex per dose:
3 per step/ 2 steps performed
Control animals:
yes
Details on study design:
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived until the end of the study without showing any signs of toxicity.
Clinical signs:
No signs of toxicology.
Body weight:
None of the animals showed weight loss during the observation period.
Gross pathology:
The test item showed no acute oral toxicity characteristics after a single dose administration.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, single oral application of the test item GS-9205 to rats at a dose of 2000 mg/kg bw was associated with no signs of toxicity or mortality.
The LD50 after a single oral administration to female rats, observed over a period of 14 days is >2000 mg/kg bw.
According to Annex I of Reg 1272/2008 EC the test item is not classified.