Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
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:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
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)
- pH value: ca. 5 (undiluted test substance moistened with water)
- Analytical purity: 97.4 g/100 g
- Lot/batch No.: EMIMCI 31F221105

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: 7 – 8 months
- Weight at study initiation: 3.71 kg – 3.76 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before application

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 g of undiluted semi-solid test substance
The solid test substance was heated at about 85°C for better handling. Before application, the test substance was cooled down to body temperature. At this temperature the test substance was semi-solid and could be applied evenly on the test patch.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
At least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animal.
Application area: 2.5 x 2.5 cm
Application site: flank
The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1 : 1).
Readings: Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14.
Body weight determination just before application of the test substance and after the last reading.
A check for any dead or moribund animal was made twice each workday (at the beginning and end of work) and once daily at weekends and on public holidays.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.6
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Readings

Animal

Exposure period: 4 h

Erythema

Edema

Additional findings

0 h

01

1

0

 

02

2

0

 

03

2

0

 

1 h

01

1

0

 

02

2

0

 

03

2

0

 

24 h

01

0

0

 

02

2

0

 

03

1

0

 

48 h

01

0

0

 

02

1

0

 

03

1

0

 

72 h

01

0

0

 

02

0

0

 

03

0

0

 

Mean  24 - 72 h

01

0.0

0.0

 

02

1.0

0.0

 

03

0.7

0.0

 

Mean

 

0.6

0.0

 

Applicant's summary and conclusion