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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:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Stepantex VS 90
- Physical state: pale yellow paste, supplied by Stepan Europe
- Analytical purity: dry content 89.6 %
- Purity test date: 1991-04-29
- Lot/batch No.: LOT 111257
- Storage condition of test material: room temperature
- Other: Specific gravity (SG ) 0.95
- pH: 3 at a 5 % solution in IPA

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Credo, 69210 L'Arbresle, France
- Age at study initiation: 6 weeks
- Weight at study initiation: males: 185 +/- 6 g; females: 151 +/- 7 g
- Fasting period before study: approx. 18 hours before administration of the test substance
- Housing: in groups of 5 animals of the same sex during the study, in polycarbonate cages (48 x 27 x 20 cm)
- Diet: ad libitum, Rats - Mice sustenance fef. A04 C (U.A.R. 91360 Villemoisson-sur.Orge, France)
- Water: ad libitum, tap water filtered by a 0.22 micron filter membrane
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): conventional air- conditioned animal room
- Photoperiod (hrs dark / hrs light): 12 hours of light / 12 hours of dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The administrations were performed in a single dose by oral route using a stainless steel round-shaped probe fitted to a 1 mL glass syringe.
The specific gravity of the test substance of 0.95 was taken into account.
Doses:
2000 and 5000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
other: historical laboratory data
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signes: after administration and at least once a day thereafter; mortality: twice daily; body weight:
just before administration and then on day 5, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, after opening the thoracic and abdominal cavities,

After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs was performed:
digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities.

In the presence of macroscopic lesions, organ samples will be taken and histological examination will be performed.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: nominal
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 480 mg/kg bw
Remarks on result:
other: based on a.i.
Mortality:
No deaths occurred at the dose levels of 2000 and 5000 mg/kg during the observation period.
Clinical signs:
No clinical signs were observed in the animals treated at the dose level of 2000 mg/kg bw.
Hypokinesia was noted only in the treated males at the dose level of 5000 mg/kg bw, 30 minutes and one hour after treatment, then in all the animals
after 2 and 4 hours. From day 2 to day 15, no clinical signs were observed.
Body weight:
The body weight gain of the animals was normal at 2000 mg/kg and of the females at 5000 mg/kg. A slight slowed down of the body weight gain was
noted between day 1 and day 5 in the males at 5000 mg/kg.
Gross pathology:
Due to the absence of macroscopic lesions, no organ samples were taken and no histological examination was performed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met