Imidazolium compounds, 2-C17-unsatd.-alkyl-1-(2-C18-unsatd. amidoethyl)-4,5-dihydro-N-methyl, Me sulfates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2007-10-03 to 2007-10-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

partially unsaturated IQAC, DMS quaternised

IUPAC Name:

partially unsaturated IQAC, DMS quaternised

Constituent 2

Reference substance name:

Imidazolium compounds, 2-(C15-17(odd numbered), C17-unsatd. alkyl)-1-[2-(C16-18(even numbered), C18-unsatd. amido)ethyl]-4,5-dihydro-N-methyl, Me sulfates)

IUPAC Name:

Imidazolium compounds, 2-(C15-17(odd numbered), C17-unsatd. alkyl)-1-[2-(C16-18(even numbered), C18-unsatd. amido)ethyl]-4,5-dihydro-N-methyl, Me sulfates)

Constituent 3

Reference substance name:

Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized

EC Number:

937-237-2

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized

Test animals

Species:

rat

Strain:

other: HanRcc: WIST(SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 11 weeks
- Weight at study initiation: 165.1 - 186.2 9 at day of application
- Fasting period before study: for approximately 17 to 18 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet: ad libitum; pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 23/07 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland)
- Water: ad libitum; community tap water from Füllinsdorf
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 -70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): the Iightening was in a 12-hour Iight/dark-cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
2000 mg/kg body weight

Doses:

Dose levels: 2000 mg/kg body weight
Concentrations: 0.2 g/mL
Dosing: one single application by gavage
Dosing volume: 10 mL/kg bw
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume).
Afterwards, the test item preparation was warmed up to 50°C. The formulations were prepared using a suitable homogenizer. The test item preparation was kept at room temperature for cooling and was administered when a temperature between 20°C and 30°C is reached. The temperature was measured before treatment with a thermometer and reached 24°C and 25.8°C.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
All animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were
performed. No organs or tissues were retained.

- Frequency of observations and weighing:

Mortality / Viability and Clinical Signs:
Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 and
twice daily during days 2-15. All abnormalities were recorded.

Body Weights:
On test days 1 (prior to administration), 8 and 15.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: no animal died

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed during the course of the study.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The partially unsaturated IQAC, DMS quaternised (100 % a.i.) is practically nontoxic based on the LD50 of greater than 2000 mg/kg body weight in female rats.  

Executive summary:

In an acute oral toxicity study test performed according to the OECD Guideline 423, 2001, 6 female 11 weeks old HanRcc:WIST (SPF) rats were given a single oral dose of partially unsaturated IQAC, DMS quaternised (100 % a.i.) in corn oil at doses of 2000 mg/kg bw and observed for 14 days.

All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.

Oral LD50     Females: > 2000 mg/kg bw