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Diss Factsheets

Administrative data

Description of key information

Oral (OECD 423), rat: LD50 cut-off >= 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 May - 21 Jun 2016
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 Dec 2001
GLP compliance:
Test type:
acute toxic class method
Limit test:
other: Crl:CD(SD), SPF
Details on test animals or test system and environmental conditions:
- Age at study initiation: 8 weeks
- Weight at study initiation: 172.3 - 193.1 g
- Fasting period before study: overnight, approx. 16 h prior and 4 h after dosing
- Housing: 1 animal per cage in stainless wire mesh cages (260W x 350D x 210H mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS. Ltd., USA), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 4 days

- Temperature (°C): 21.4 - 23.3
- Humidity (%): 43.1 - 59.7
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
corn oil
Details on oral exposure:
- Concentration in vehicle: 400 mg/mL
- Lot/batch no.: MKBV2080V (SIGMA-ALDRICH, Co., USA)


- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance 2000 mg/kg bw was selected as the starting dose.
2000 mg/kg bw (Steps 1 and 2)
No. of animals per sex per dose:
3 females per step
Control animals:
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
Key result
Dose descriptor:
LD50 cut-off
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred in Step 1 and 2 at 2000 mg/kg bw in an OECD 423 study
No mortality was observed during the study period.
Clinical signs:
Abnormal gait was observed in all animals at 2000 mg/kg bw from 4 to 6 h after dosing. Mucous stool was observed in three animals and soiled perineal region and decrease of fecal volume were observed in each one animal on Day 1. These animals returned to a normal appearance on Day 2. These clinical signs were considered to be test substance-related.
Body weight:
A tendency to suppressed body weight gain was observed in one animal on Day 1. This animal returned to normal on Day 3. This change was considered to be test substance-related.
Gross pathology:
No grossly visible evidence of morphological abnormalities was observed in any animal.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
In this acute oral toxicity study in rats a LD50 cut-off of >= 5000 mg/kg bw was derived.
Executive summary:

There were no deaths of animals at 2,000 mg/kg. Abnormal gait was observed in animals at 2,000 mg/kg on the day of dosing. Mucous stool, soiled perineal region and/or decrease of fecal volume were observed in animals at 2,000 mg/kg on Day 1. These animals returned to a normal appearance on Day 2 after dosing. A tendency of suppressed body weight gain was observed in animals on Day 1 after dosing. Then, this animal returned to normal on Day 3. No test substance-related effects were observed in necropsy findings in any animal.

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.

Additional information

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 and in compliance with GLP (2016). In this study, no mortality was observed at 2000 mg/kg bw (Steps 1 and 2) in female rats. Thus, a LD50 cut-off of >= 5000 mg/kg bw was derived

Justification for classification or non-classification

The available data on acute oral toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.