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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:
Experiment Start 2015-03-02; Experiment Termination 2015-03-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline 423 Acute Toxic Class (ATC) was used in compliance with principles of Good Laboratory Practices

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Statement of GLP Compliance No. G-026 from the SNAS
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: clear viscous liquid
Details on test material:
Stabilized EMIM BF4:
Purity: 93.36% (EMIM+, HPLC), 86.68% (BF4-, titration); 4.89% (Stabilizer, HPLC)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Number and Sex of Animals:
Received: 3 males and 9 females
Used: 3 males and 6 females
Age at first dose:
At least 6-7 weeks; female animals were non-pregnant and nulliparous
Animal Health:
The health condition of the animals were examined by a veterinarian before inition of the study
Acclimatisation:
The animals were acclimated under the conditions identical to ther conditions during the experiments prior 5 days to
the start of treatment. The acclimation was according to the standard operation procedure.
Housing condition:
The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, males and females seperately in a room equipped with central air conditioning. The room temperature was maintained within the range of 22 +/- 2 °C, relative humidity of 55 +/- 10 %. The light regimen was set to the 12-hour light / 12-hour dark cycle (deviation +/- 30 minutes). The sanitation was performed according to the standard operation procedures.
Diet:
A laboratory food Altromin (Altromin Spezialfutter GmbH, Germany) was offered in recommended doses each day
approximately at the same time after dosing.
Water:
The animals received tap water for human consumption. Supply pf trinking water was unlimited.
Bedding:
Lignocel S3/4, Lufa - ITL GmbH, Germany

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test item was administered in a single dose by gavage using a stomach tube.
Doses:
A limit dose of 2000 mg/kg was used as starting dose.
The required amount of the test item was adminisered without dilution according to the actual body weight. The dosage was recalculated with respect to the water content in order to administer 2000 mg/kg pure test item.
No. of animals per sex per dose:
6 female and 3 male rats were tested at the dose of 2000 mg/kg
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the study. Animals lived through observation period without important visible signs of intoxication.
Clinical signs:
1/2 hour after administration all animals were a slight sleepy. Later all observed parameters were normal. Neither change of health nor negative reactions were registered.
Body weight:
The body weights of all animals were increasing during the study. No body weight losses were observed one and two weeks after application.
Gross pathology:
All animals (6 females and 3 males) were necropsied. During the examination, no macroscopically changes were noticed.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Based on OECD TG 423 it can be concluded that the used test item is classified in category 5/Unclassified with the cut off LD50 >= 5000 mg/kg, after single oral administration to Wistar rats.
Executive summary:

The purpose of the study was to evaluete the potentioal toxic effect of the test item stabilized EMIM BF4 when administered as a single oral dse to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. Available information indicated that the test item is likely to be non-toxic; therefor a limit dose of 200 mg/kg was used as starting dose. Groups of 6 females and 3 males were dosed. Since all 6/6 females and all 3/3 males survived limit dose 2000 mg/kg no further dosing was necessary. The limit dose 2000 mg/kg did not cause death, evident symtoms of toxicity or body weight loss during the 14 day long observation period.

Based on OECD 423 Flow Chart at starting dose of 2000 mg/kg it can be concluded that the test item stabilized EMIM BF4 is classified in Category 5/Unclassified with the cut off LD50 >= 5000 mg/kg, after single oral administration to Wistar rats.