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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26/07/2010-18/08/2010
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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
other: Commission Regulation (EC) No.440/2008, L142, Annex part B, 30 May 2008
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
ethyl 3-[5-(3-chloro-2-fluorobenzyl)-2,4-dimethoxyphenyl]-3-oxopropanoate
EC Number:
638-801-8
Cas Number:
949465-81-0
Molecular formula:
C20H20ClFO5
IUPAC Name:
ethyl 3-[5-(3-chloro-2-fluorobenzyl)-2,4-dimethoxyphenyl]-3-oxopropanoate
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: 163-167 g; Animals N.4-6, step 2: 147-159 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
Details on oral exposure:
The test item was administered at a single dose by gavage using a feeding tube.
Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
3 per step
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:
No compound-related mortality was recorded for any animal of step 1 or 2.
Clinical signs:
No signs of toxicity.
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-9207 to rats at a dose of 2000 mg/kg bw was associated with no signs of toxicity nor mortality.
The median lethal dose of GS-9207 after single oral administration to female rats, observed over a period of 14 days is: LD50 cut off (rat): unclassified.
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item GS-9207 has no obligatory labelling requirement for toxicity.
According to Annex I of regulation (EC) 1272/2008 the test item GS-9207 was unclassified.
According to OECD-GHS the test item GS-9207 has no obligatory labelling requirement for toxicity.