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Administrative data

Description of key information

Oral (OECD 423), rat LD50 cut off 5000 mg/kg bw (limit test)

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:
30 May - 20 Jun 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted: 17 Dec 2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Remarks:
(Crl:CD(SD)), SPF
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 8 weeks
- Weight at study initiation: 186.9−197.8 g
- Fasting period before study: overnight, approx. 26 h prior to dosing
- Housing: individually in stainless wire mesh cage, 260W×350D×210H (mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS, Inc., U.S.A.), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9−23.6
- Humidity (%): 45.5−53.3
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Lot/batch no.: MKBZ9899V
- Concentration in vehicle: 400 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance, 2,000 mg/kg was selected as the
starting dose for this study based on the information supplied by the sponsor.
Doses:
2000 mg/kg bw (step 1 and step 2)
No. of animals per sex per dose:
3 females per step
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min and 1, 2, 4 and 6 h after dosing and thereafter once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
Statistics:
Statistical analysis was not performed. Mean scores and values were determined.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Mucous stool was observed in two animals at 2000 mg/kg bw on Day 1, and it disappeared on Day 2. Therefore, it was considered to be a test substance-related temporary change.
Body weight:
A decrease in body weight was observed in one animal at 2000 mg/kg bw on Day 3. Normal body weight gain was observed in this animal from Day 7. It was not considered to be a test substance-related effect because there were no clinical signs or necropsy findings of morphologic abnormalities.
Gross pathology:
No grossly visible findings were observed in any animal.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
In this acute oral toxicity study in rats a LD50 value of ≥ 5000 mg/kg bw was found.
Executive summary:

The purpose of this study was to assess the potential toxicity of the test substance following a single oral dose administration to female Sprague-Dawley rats and to classify the test substance under the category of GHS classification.

Two dose groups of three females were utilized as follows:

Groups 1 and 2 (Steps 1 and 2): 2,000 mg/kg of the test substance

There was no mortality.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch Score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006.

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

The acute oral toxicity of the test substance was assessed in a limit test according to OECD Guideline 423 and in compliance with GLP (2017). In a first step, a group of 3 female rats was given a single dose of 2000 mg/kg bw oral by gavage. Since no mortility occured, a further group of 3 female rats was administred 2000 mg/kg bw. No mortality occured. Mucous stool was observed in animals on Day 1, and it disappeared on Day 2. No test substance-related effects were observed in body weight data or necropsy findings.

Based on the results of this study, the oral LD50 value was determined to be 5000 mg/kg bw in rats.

Justification for classification or non-classification

The available data on acute oral toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.