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Description of key information

OECD 423, RL1: LD50 > 2000 mg/kg bw (female rats)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Jun - 15 Aug 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 162 - 176 g
- Fasting period before study: 17-20 h before start of treatment until 4 h thereafter
- Housing: Type III Macrolon cages with a shelter on softwood bedding material. A play tunnel was placed in the cages as additional enrichment.
- Diet (e.g. ad libitum): maintenance diet (V1534, ssniff Spezialdiäten GmbH, Germany), ad libitim
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light):
Route of administration:
oral: gavage
Vehicle:
other: Methocel K4M Premium solution (0.25% aqueous Hydroxypropylcellulose)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Due to the fact, that no information concerning the toxic potential of the compound to be tested is available, the study was started in 3 females with 300 mg/kg body weight.
Doses:
300, 2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
Mortality and Clinical Signs:
On the day of treatment, each animal was observed for mortality and for symptoms of intoxication at scheduled intervals. On the following days, the rats were examined once daily. Symptoms were recorded individually for each animal.

Body weight:
All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13 and 15.

Pathology:
At the end of the experimental part the surviving animals were sacrificed via air / carbon dioxide mixture ans exsanguination after opening the abdominal vessels. All rats were subject to a gross pathological examination and macroscopic findings were noted.

Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was seen.
Clinical signs:
No clinical signs of toxicity were observed.
Body weight:
There were no effects on body weight development throughout the study.
Gross pathology:
No organ alterations were identified during the gross pathological examination.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item has no acute toxic potential under the conditions of the present study, and the LD50 value is > 2000 mg/kg bw after single oral administration in rats.
Executive summary:

The objective of the present study was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure.

The study was started with 300 mg /kg in 3 female rats, continued with further 3 females treated with 300 mg/kg. Due to the fact, that no mortality was seen after treatment with 300 mg /kg, 6 further females were treated with 2000 mg/kg.

Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.

No mortality occurred during this study. No clinical signs of toxicity were observed.

The body weight development was inconspicuous throughout the study. The gross pathological examination revealed no organ alterations.

The test item has no acute toxic potential under the conditions of the present study, and the LD50 value is higher than 2000 mg/kg after single oral administration in female rats.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
OECD Guideline study under GLP conditions

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity study

The objective of the present study was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure.

The study was started with 300 mg /kg in 3 female rats, continued with further 3 females treated with 300 mg/kg. Due to the fact, that no mortality was seen after treatment with 300 mg /kg, 6 further females were treated with 2000 mg/kg.

Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.

No mortality occurred during this study. No clinical signs of toxicity were observed.

The body weight development was inconspicuous throughout the study. The gross pathological examination revealed no organ alterations.

The test item has no acute toxic potential under the conditions of the present study, and the LD50 value is higher than 2000 mg/kg after single oral administration in female rats.

 

Justification for classification or non-classification

The substance is not classified for acute oral toxicity according to Regulation (EC) No 1272/2008.