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Description of key information

The test substance was tested for acute oral toxicity according to OECD TG 423 and under GLP. A single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with any signs of toxicity or mortality during an observation period of 14 days. The LD50 cut-off (rat) was therefore determined to amount 5000 mg/kg bw.

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:
2016-06-30 to 2016-09-26
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)
Version / remarks:
adopted 17 December 2001
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
WISTAR rats Crl: WI(Han)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: animals no. 1 – 3: 11 - 12 weeks old; animals no. 4 – 6: 8 - 9 weeks old
- Weight at study initiation: animals no. 1 – 3: 171 – 187 g; animals no. 4 – 6: 152 – 161 g
- Fasting period before study: 16 to 19 hours

- Housing: group housing in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): ad libitum, Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): ad libitum, tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: Step 1, animals no. 1 - 3: 07 June - 05 July 2016; Step 2, animals no. 4 - 6: 05 - 12 July 2016

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg.
- Justification for choice of vehicle: preparation with corn oil yielded a well applicable suspension, corn oil has non-toxic characteristics, test substance is insoluble in water
- Lot/batch no. (if required): Sigma-Aldrich, lot no. MKBV2080V


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: toxicity was not expected
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
3 per step, 2 steps performed
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animal were examined once daily, on the day of dosing, examination was carried out several times (at least once during the first 30 minutes and special attention was given during the first 4 hours post-dose), animals were weighed on day 1 (prior to the administration), day 8 and day15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
not observed
Clinical signs:
no specific findings during the whole observation period
Body weight:
none of the animals showed weight loss during the observation period (please see attached file for individual data)
Gross pathology:
no specific gross pathological changes were recorded for any animal

Please see attached file for results.

Interpretation of results:
GHS criteria not met
Conclusions:
- A single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality
- The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 5000 mg/kg bw
- According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for toxicity and is not classified.
- According to GHS (Globally Harmonized Classification System), the test item has no obligatory labelling requirement for toxicity and is not classified.
Executive summary:

A valid test for acute oral toxicity according to OECD Guideline and under GLP was carried out with the test substance and did not identify any signs of toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Justification for classification or non-classification

The LD50 cut-off (rat) was determined to amount 5000 mg/kg bw in a test for acute oral toxicity according to OECD TG 423 and under GLP. According to Annex I of Regulation (EC) 1272/2008 and GHS (Globally Harmonized Classification System), the test substance therefore has no obligatory labelling requirement for toxicity and is not classified.