Registration Dossier
Registration Dossier
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EC number: 257-196-8 | CAS number: 51422-54-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-04-07 to 1987-04-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)-2-methylpropane
- EC Number:
- 257-196-8
- EC Name:
- 2-(2-ethoxyethoxy)-2-methylpropane
- Cas Number:
- 51422-54-9
- Molecular formula:
- C8H18O2
- IUPAC Name:
- 2-(2-ethoxyethoxy)-2-methylpropane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.0 - 2.1 kg
- Housing: Stainless steel cages, one animal per cage
- Diet: Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 cm3
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours and 7, 8, 10 and 14 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2 skin area
- Type of wrap: cotton wool rolls and polyethylenfilm
REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- The test item showed skin irritating effects. According to CLP criteria a classification is not necessary.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
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