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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 18 Jun 2017 to 3 Aug 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
17 December 2001
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Version / remarks:
30 May 2008
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax
EC Number:
911-428-0
IUPAC Name:
Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax
Test material form:
solid: flakes
Details on test material:
Test item: WARADUR® LG
Purity (certified): > 99.5%
Water solubility: not specified
Stability under test conditions: Not specified
Appearance: Pale yellow, solid flakes
Expiry date: 2018-04-11

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 12 weeks
- Weight at study initiation: 236 - 253 g
- Fasting period before study: overnight
- Housing: individually (pre-tests), group of 4 (main study)
- Diet (ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice - breeding and maintenance" by ssniff Spezialdiäten GmbH, Soest, Germany
- Water (ad libitum): tap water from the municipal supply
- Acclimation period: at least 35 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 – 24.3
- Humidity (%): 31 – 70 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 or 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: due to lack of any preliminary toxicological information, 300 mg/kg bw was selected to be the starting dose
Doses:
300, 2000 mg/kg bw
No. of animals per sex per dose:
1 in pre-tests (300, 2000 mg/kg bw), 4 in main study (2000 mg/kg bw)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter, weighing on the day before treatment (Day -1), on the day of the
treatment (Day 0) and on Day 7 and Day 14 (before necropsy).
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Preliminary study:
No mortality was observed in 1 female rat each exposed to 300 or 2000 mg/kg bw
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no evidence of any macroscopic changes in the surviving rats
Mortality:
not observed
Clinical signs:
not observed
Body weight:
no effects
Gross pathology:
no effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this acute toxicity test according to OECD guideline 420, the LD50 in female rats was > 2000 mg/kg bw
Executive summary:

The acute oral toxicity study with WARADUR LG was performed according to the acute toxic class method (OECD 420 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.bis) in Crl:WI Wistar female rats.

Initially, in the sighting study, one female was treated at the dose level of 300 mg/kg bw. As no mortality was observed, one female was treated at the dose level of 2000 mg/kg bw. As no mortality was observed, the main study was conducted with four animals treated at the same dose level. No mortality was observed in the main study; therefore, no further testing was required.

A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered formulated in PEG 400 at a concentration of 30, or 200 mg/mL at a dosing volume of 10 mL/kg bw.

Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0 and 7 and Day 14 (before necropsy). All animals were subjected to a necropsy and a macroscopic examination.

WARADUR LG did not cause mortality in the study. All treated animals were symptom-free during the observation period. Body weight gains of WARADUR LG treated animals during the study showed no indication of a treatment-related effect. There was no evidence of any macroscopic changes in the surviving rats at the dose levels of 300 and 2000 mg/kg bw.

Under the conditions of this study, the acute oral LD50 value of the test item WARADUR LG was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.

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