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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:
other: according to guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
content: 95.54 weight %
high viscosity, brown

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals 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:
2000 mg/kg bw:
piloerection, abdominal position, labored breathing
300 mg/kg bw
no clinical signs
Body weight:
no toxicological effects on body weight or body weight gain in animals treated with 300 mg/kg bw
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