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Diss Factsheets

Administrative data

Description of key information

Oral (OECD 423), rat: LD50 > 2000 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:
22 Mar - 18 Apr 2016
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 Dec 2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
other: Crl:CD(SD), SPF
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 170.9 - 214.6 g
- Fasting period before study: overnight, approx. 16 h prior and 4 h after dosing
- Housing: 1 animale per cage in stainless wire mech 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

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 - 24.0
- Humidity (%): 43.5 - 58.5
- 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.: MKBV2080V and MKBS6944V (SIGMA-ALDRICH, Co., USA)

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 300 mg/kg bw because there was no available toxicity information on the test substance.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
6
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
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off of 5000 mg/kg bw according to OECD 423
Mortality:
No mortality was observed at 300 and 2000 mg/kg bw, respectively.
Clinical signs:
other: Mucous stool was observed in two animals at 300 mg/kg bw on Day 1. The clinical sign disappeared on Day 2. Therefore, it was considered to be a test substance-related temporary change. No clinical abnormalities were observed in any animal at 2000 mg/kg bw
Gross pathology:
No grossly visible evidence of morphological abnormalities was observed in any animal at 300 and 2000 mg/kg bw, respectively.
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 performed in rats a LD50 > 2000 mg/kg bw was found.
Executive summary:

There were no deaths of animals at 300 mg/kg. Mucous stool was observed in animals at 300 mg/kg on Day 1, and it disappeared on Day 2. No test substance-related effects were observed in body weight data or necropsy findings in any animal at 300 mg/kg.

There were no deaths of animals at 2,000 mg/kg. No test substance-related effects were observed in clinical signs, body weight data or necropsy findings in any animal at 2,000 mg/kg.

Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was classified as Category 5 or Unclassified according to the GHS classification and the median lethal dose derived was: LD50 cut off≥ 5,000 mg/kg b.w.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
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 study according to OECD Guideline 423 and in compliance with GLP (2016). In this study, no mortality was observed and a LD50 > 2000 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 conclusive but not sufficient for classification.