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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
Study period:
December 7, 2010 - February 21, 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
(2002)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): F10Fine
- Physical state: colourless solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation:
Step 1/animals no. 1-3: 147-159 g
Step 2/animals no. 4-6: 150-166 g
- Fasting period before study: 16 to 19 hours
- Housing: the animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 040810)
- Diet: free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1013). Free access again from 4 hrs post dosing.
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Date of Dose Administration:
Step 1, animals no. 1, 2 and 3: December 22, 2010
Step 2, animals no. 4, 5 and 6: December 29, 2010

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.4 g/mL
- Amount of vehicle: 5 mL
- Justification for choice of vehicle: due to its non-toxic characteristics
- Lot/batch no.: Sigma, lot no. MKBB7604, expiry date 30/01/2011
- Purity: not applicable

DOSE VOLUME APPLIED: 5 mL/kg

DOSAGE PREPARATION: the test item was weighed out into a tared plastic vial on a precision balance. Homogeneity was maintained by vortexing. The dosages were made shortly before administration.

CLASS METHOD
- Rationale for the selection of the starting dose: no details provided
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 females twice (6 females in total)
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: the animals were weighed on day 1 (prior to the administration), on day 8 (1 week thereafter) and on day 15 (2 weeks thereafter)
- Frequency of observations: a careful clinical examination was made several times on the day of dosing (at least once during the 1st 30 minutes and with special attention given during the 1st 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. According to the OECD Guideline.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities occurred
Mortality:
- No mortalities occurred
Clinical signs:
- At 3 and 4 hours after administration, slight to moderate reduced spontaneous activity, prone position and piloerection was observed in the 3 animals of the 1st group, until day 2
- No other signs were observed in any of the animals at any observation time
Body weight:
- No abnormalities were observed. The animals had a weight gain of 18 to 30% during the observation period
Gross pathology:
- No abnormalities were observed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study in female rats, conducted in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles, a LD50 oral of >2000 mg/kg was determined.
Executive summary:

The acute oral toxicity in female rats has been studied in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles. The substance was dosed in cotton seed oil at 2 g/kg bw in 6 female rats, in 2 steps. At 3 and 4 hours after administration, slight to moderate reduced spontaneous activity, prone position and piloerection was observed in the 3 animals of the 1st group, until day 2. No mortalities occurred. Necropsy did not show any abnormality. The acute oral toxicity (LD50) was determined to be >2000 mg/kg. Based on this result, the substance does not need to be classified for acute toxicity by the oral route.