Registration Dossier
Registration Dossier
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EC number: 616-466-9 | CAS number: 77501-63-4
Acute Toxicity: oral
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:
- other: according to guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- (2-ethoxy-1-methyl-2-oxoethyl)-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate
- EC Number:
- 616-466-9
- Cas Number:
- 77501-63-4
- Molecular formula:
- C19H15ClF3NO7
- IUPAC Name:
- (2-ethoxy-1-methyl-2-oxoethyl)-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate
- Test material form:
- other: solid
- Details on test material:
- content: 95.54 weight %
high viscosity, brown
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation:10-12 weeks
- Weight at study initiation: 165-192 g
- Fasting period before study: 16-24 h
- Housing:
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: corn oil with the aid of acetone
- Details on oral exposure:
- Rats received single oral dose by gavage.
For oral administration lactofen was melted at 70 °C and formulated in corn oil with the aid of 10 % acetone (dried with molecular sieve). the applied formulations were well mixed before administration. The formulations for administration were prepared at room temperature. The administration volume was 10 ml/kg bw - Doses:
- 3 females 2000 mg/kg bw
3 females 300 mg/kg bw
3 females 300 mg/kg bw - No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- Rats received single oral dose by gavage.
For oral administration lactofen was melted at 70 °C and formulated in corn oil with the aid of 10 % acetone (dried with molecular sieve). The applied formulations were well mixed before administration. The formulations for administration were prepared at room temperature. The administration volume was 10 ml/kg bw
The starting dose level should be that which is most likely to produce mortality in some of the dosed animals. Absence or presence of compound-related mortality of the amimals dosed at one step will determine the rext step.
no further testing is needed
dosing of three additional animals wth the the same dose
dosing of three addional animals at the next higher or lower dose level - Statistics:
- The LD50 was estimated according to OECD Guideline for testing of chemicals No. 423
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD100
- Effect level:
- ca. 2 000 mg/kg bw
- Remarks on result:
- other: the clinical signs were piloerection, abdominal position, labored breathing
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- ca. 300 mg/kg bw
- Remarks on result:
- other: the substance was tolerated without clinical signs
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 500 mg/kg bw
- Mortality:
- all animals dosed with 2000 mg/kg bw died
all animals dosed with 300 mg/kg bw survived the treatment - Clinical signs:
- other: 2000 mg/kg bw: piloerection, abdominal position, labored breathing 300 mg/kg bw no clinical signs
- Gross pathology:
- 2000 mg/kg bw : urinary bladder enlargedm liver spoted, kidneys pale spotted
300 mg/kg bw: no particular findings - Other findings:
- no data
Applicant's summary and conclusion
- Conclusions:
- According to OECD Guideline 423 the LD50 cut-off of lactofen is 500 mg/kg bw
- Executive summary:
Female Wistar rats were tested for acute oral toxicity according to OECD TG 423 and GLP. All animals dosed with 2000 mg/kg bw died during the observation period; the clinical signs were piloerection, abdominal position and labored breathing, The gross pathological examination revealed enlarged urinary bladderm spotted liver and pale spoted kidneys. The dose of 300 mg /kg bw was tolerated without any findings. According to OECD Guideline 423 the LD50 cut-off of lactofen is 500 mg/kg bw
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