Registration Dossier
Registration Dossier
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EC number: 684-879-1 | CAS number: 848641-69-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-Ethyl-3-methylimidazolium Diethyl Phosphate
- Cas Number:
- 848641-69-0
- Molecular formula:
- C6H11N2 C4H10O4P
- IUPAC Name:
- 1-Ethyl-3-methylimidazolium Diethyl Phosphate
- Test material form:
- liquid
- Details on test material:
- Batch No 187-9-113-Y
Expiry date: 2021-1-30
Constituent 1
- Specific details on test material used for the study:
- Yellow liquid
Batch no.: Batch 1.3
20% water (Correction factor 1.25)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Manfred Bauer Kaninchen, 74632 Neuenstein, Germany
- Age at study initiation: approx. 8.5 months
- Weight at study initiation: 3.5 - 3.9 kg
- Housing: individually in cages measuring 380 mm x 425 mm x 600 mm
- Diet (e.g. ad libitum): ssniff k-H V 2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany), ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 07.11. To: 29.11.2016
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- other: the surrounding untreated skin served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.625 mL
- Concentration (if solution): pure
VEHICLE
- Amount(s) applied (volume or weight with unit): n.a.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): no required
POSITIVE CONTROL
- Amount(s) applied (volume or weight): not required - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
readings: 60 min, 24, 48, 72 h, 7 and 14 d after patch removal - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm(2)
- % coverage: 100
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n.a.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
60 min, 24, 48, 72 h, 7 and 14 days after patch removal
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Under the present test conditions, none of the three rabbits exposed for 4 hours to 0.625 mL of the test item (semi-occlusive conditions) revealed any skin reaction.
- Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to GHS and EC regulation 1272/2008 the test item is non-irritating.
- Executive summary:
The test substance was tested for its skin irritant properties in 3 New Zealand White rabbits. Due to the water content of 20% 0.625 mL of the substance were applied to the clipped skin. None of the three rabbits exposed for 4 h revealed any skin reaction. There were no systemic intolerance reactions.
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