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

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

17 December 2001

Test guideline 2

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

Test material information

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:

other: not observed

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.