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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05. Oct. 2004 - 22. Oct. 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Species : Albino Rabbit, New Zealand White, (SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. EC, OECD)
Source : Charles River Deutschland, Kisslegg, Germany
Number of animals : 3 Males.
Age and body weight : Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.
Identification : Earmark.
Conditions : Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0°C (actual range: 16.7 - 22.2°C), a relative humidity of 30-70% (actual range: 37 - 74%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
Accommodation : Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet : Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g. per day, Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netherlands) was provided at least three times a week.
Water : Free access to tap-water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Each animal was treated by dermal application of 0.5 ml of the test substance. The test substance was applied to the skin of one flank, using a metalline patchll of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
Suppliers: Lohmann GmbH, Neuwied, Germany (Metalline) and 3M, St. Paul, Minnesota, U,SA (Micropore and Caban).
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.
Number of animals:
3
Details on study design:
All available data relevant to the potential dermal irritation/corrosivity of the substance indicated that no severe effects were to be expected. An in-vitro test was considered, but a negative test result was anticipated that still would have to be confirmed in an in-vivo study. Since no severe harm for the animals was to be expected, this in-vivo skin irritation study was performed and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner two weeks later, after considering the degree of skin irritation observed in the first animal.
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10 x 15 cm2). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.
A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Other effects:
There was no evidence of a corrosive effect on the skin. No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Animal no.

Sex

Age at start [weeks]

Body weight [grams]

Mean 24 -72 hrs

 

 

 

Prior to application

At termination

Erythema

Oedema

243

Male

7 - 9

1353

1468

0

0

281

Male

7 - 9

1490

1610

0

0

286

male

7 - 9

1361

1468

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No skin irritation was caused by 4 hours exposure to 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE .
Based on these results and according to:
- the OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE does not have to be classified for skin irritation.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

Primary skin irritation/corrosion study with 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE in the rabbit (4-hour semi-occlusive application). The study was carried out based on the guidelines described in: OECD No.404, "Acute Dermal Irritation/Corrosion" (2002); EC Commission Directive 2004/73/EC, BA, "Acute Toxicity - Skin irritation" (2004); US EPA, OPPTS 870.2500, Acute Dermal Irritation (1998) and JMAFF, Japanese Test Guidelines (2000). Three rabbits were exposed to 0.5 ml of 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

No skin irritation was caused by 4 hours exposure to 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE . Based on these results and according to the:

- OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE does not have to be classified for skin irritation.

- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE does not have to be classified and has no obligatory labelling requirement for skin irritation.