Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: 1-Ethyl-3-methyl-1-imidazolium chloride (EMIM CI)
- Analytical purity: 97.4 g/100 g
- Lot/batch No.: EMIMCI 31F221105

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd Laboratory Animal Services, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: Young adult animals (male animals approx. 8 – 10 weeks, female animals approx. 12 – 14 weeks)
- Weight at study initiation: Young adult animals of a comparable weight were used (± 20% of the mean weight)
- Housing: Single housing in stainless steel wire mesh cages, type DK-III.
- Diet (e.g. ad libitum): ad libitum, Kliba-Labordiaet (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland
- Water (e.g. ad libitum): ad libitum, Tap water
- Acclimation period: t least 5 days before application

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
The aqueous formulation corresponds to the physiological medium.
For better handling the test substance was heated at ca. 85°C. The test-substance preparation was produced for the application group shortly before application by stirring with a magnetic stirrer. Before application the preparation was cooled down to body temperature.
Form of application: solution
Concentration used: 80 g/100 ml
Application volume: 2.5 ml/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Clipping of the fur about 24 hours before the beginning of the study. Rinsing of the application site with warm water.
Application area: about 40 cm² (corresponds to at least 10% of the body surface)
Observation period: at least 14 days
Individual body weight determination shortly before application (day 0), weekly thereafter and at the end of the study.
Recording of signs and symptoms several times on the day of application, at least once each workday for the individual animals.
Individual readings 30 – 60 minutes after removal of the semiocclusive dressing (day 1), as a rule weekly thereafter and at the end of the study (last day of the observation period).
The evaluation of skin reactions is performed according to Draize, J.H. (1959).
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
Necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
No systemic clinical observations or skin effects were noted in the animals.
Body weight:
The mean body weights of the animals increased throughout the study period.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Applicant's summary and conclusion