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Toxicological information

Acute Toxicity: oral

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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:
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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate
EC Number:
601-478-9
Cas Number:
117428-22-5
Molecular formula:
C18H16F3NO4
IUPAC Name:
methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate
Test material form:
solid
Details on test material:
- Purity: 99.3%

Test animals

Species:
mouse
Strain:
CD-1
Remarks:
(CRL: CD1(ICR))
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bred at IIBAT animal house facility
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 23-28 g
- Fasting period before study: 3 hours prior to dosing.
- Housing: Standard polypropylene mouse cages with stainless steel top grills
- Diet: ad libitum except during fasting
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20.1-23.0°C
- Humidity: 51-58%.
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
0.5% aqueous methylcellulose
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg.b.w.
Doses:
1750 and 5000 mg/kg bw
No. of animals per sex per dose:
1750 mg/kg: 1
5000 mg/kg: 3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs at half an hour, 1, 2, 3 and 4 hours after dosing, then once daily for 14 days. Body weight of each animal was recorded on day 0 (prior to dosing) and on day 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
The LD50 was calculated by using the software AOT425 StatPgm

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No morbidity/mortality was observed in treated animals throughout the observation period.
Clinical signs:
Two mice dosed at 5000 mg/kg b.w. exhibited dullness at 30 minutes after the test substance administration and recovered by 1 hour. No clinical signs were observed in the remaining animals.
Body weight:
All of the animals showed body weight gain during the experimental period.
Gross pathology:
No macroscopic lesions were present in the animals at necropsy conducted at the end of the experimental period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (Female): >5000 mg/kg bw
Executive summary:

Acute oral toxicity of the test substance was tested in female CD1 mice. The study was conducted as per the OECD guideline (Guideline No. 425, Adopted 3rd October, 2008) and U.S. EPA Heath Effects Test Guidelines OPPTS 870.1100 (2002).

The test substance, mixed with 0.5% aqueous methylcellulose, was administered as a single oral gavage dose to one fasted female mouse at a dose level of 1750 mg/kg and to three fasted female mice at a dose level of 5000 mg/kg using a stainless steel ball tipped oral intubation needle. The animals were dosed in sequence at a minimum of 48 hour intervals.

Animals were observed for clinical signs of toxicity, morbidity/mortality for a 14 day observation period. Weekly body weights were recorded. At the end of the observation period, the animals were sacrificed for gross pathology observation.

No deaths occurred. Two of the mice dosed at 5000 mg/kg exhibited dullness at half an hour after dosing. No other clinical signs were observed. Weekly body weight gain was observed. Gross pathology examination revealed no lesions.

In conclusion, the acute oral LD50 of the test substance was determined to be greater than 5000 mg/kg bw.