3-methyl-1-vinyl-1H-imidazolium chloride

Endpoint summary

Description of key information

The acute oral LD value of the test material was determined to be 4780 mg/kg bw (combined male and female).
The acute dermal LD value ot the test material analogue 3-methyl-1-vinyl-vinylimidazolium methosulfate was determined to be greater than 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:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study report which meets basic scientific principles

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. k. Thomae GmbH, Biberach, Germany
- Weight at study initiation: animals of comparable weight (+/- 20 % of mean weight)
- Fasting period before study: 16 hours
- Housing: in groups of 5 separated by sex
- Diet: Kliba Labordiaet, Klingenthalermuele, Kaiseraugst, Switzerland, ad libitum
- Water:Tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50, 38.3, 26.1 % (w/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2610, 3830, 5000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females per dose level

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily on working days, at least once on weekends and public holidays
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 values were determined by probit analysis according to Finney et al. (1971)

Sex:

male

Dose descriptor:

LD50

Effect level:

4 660 mg/kg bw

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 780 mg/kg bw

95% CL:

4 220 - 6 830

Mortality:

5000 mg/kg dose level: 4/5 males, 2/5 females
3830 mg/kg dose level: 0/5 males, 1/5 females
2610 mg/kg dose level: 0/5 males, 0/5 females

Clinical signs:

nothing abormal reported

Body weight:

nothing abnormal reported; all animals showed slight to normal body weight gain during the observation period

Gross pathology:

Deceased animals: general congestive hyperemia
Sacrificed animal: nothing abnormal detected

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 780 mg/kg bw

Quality of whole database:

Acceptable and well documented study similar to OECD TG No. 401.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Study period:

2011-10-17 and 2012-01-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-conform study according to OECD guideline, EU method as well as EPA TG; for read-across justification, please refer to section 13

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

1998

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: male: 237.4 g (mean), female: 204.6 g (mean)
- Housing: single
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip,Germany
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm2
- % coverage: at least 10% of the body surface
- Type of wrap: 4 layers of absorbent gauze and stretch bandage

REMOVAL OF TEST SUBSTANCE
- Washing: done with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 3.33 mL/kg bw
- Concentration: 60 g/100 mL
- Constant volume or concentration used: no data
- The solid test substance was dissolved in deionized water to contain a solution.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observation and weighing: before administration (day 0), weekly thereafter and on the last day of observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

No systemic and local clinical signs were observed during clinical examination.

Body weight:

The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range, with the exception of one female which still showed stagnation of body weight.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP-conform study in accordance with OECD guideline, EU method, US EPA guidline and Japan Maff guideline. Test substance analogue was used.

Additional information

Acute oral toxicity

An acute oral toxicity study in female and male rats was performed to estimate the potential acute hazard after single administration of the test substance. A solution of the test material was exposed by gavage to the following doses: 5000, 3830 or 2610 mg/kg bw. The animals fasted 16 hours before admistration, but water was available ad libitum. The animals were observed over a period of 14 days. Signs and symptoms were recorded several times on the day of admistration and at least once each workday. Check for moribund and dead animals twice each workday and once on holiday. No clinical signs were reported. All animals showed slight to normal body weight gain during the observation period. Gross pathology was performed. While deceased animals showed general congestive hyperemia, sacrificed animals showed no abnormalities of the organs. The follwing rate of death were observed after 14 days:

2610 mg/kg bw: 0/10 animals

3830 mg/kg bw: 1/10 animals

5000 mg/kg bw: 6/10 animals.

In conclusion, the acute oral LD50 value of the test material was found to be 4780 mg/kg bw (combined male and female).

Acute dermal toxicity

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the test substance analogue 3 -methyl-1-vinyl-1 H-imidazolium methyl sulfate (as solution in doubly deionized water) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. The following test substance-related observations were recorded:

- No signs of systemic toxicity or skin effects.

- The mean body weight of the male animals increased within the normal range throughout the study period.

- The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range, with the exception of one female which showed still stagnation of body weight..

- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

- No mortality occurred.

Accordingly, the acute dermal median lethal dose (LD50) was determined to be greater than 2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Only one reliable study.

Justification for selection of acute toxicity – dermal endpoint
Only one reliable study.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the test substance is not considered to be classified for acute oral and dermal toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the test substance is not considered to be classified for acute oral and dermal toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.