Registration Dossier
Registration Dossier
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EC number: 216-653-1 | CAS number: 1634-04-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP guideline study, dermal application under occlusive conditions, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive application
- GLP compliance:
- no
Test material
- Reference substance name:
- tert-butyl methyl ether
- EC Number:
- 216-653-1
- EC Name:
- tert-butyl methyl ether
- Cas Number:
- 1634-04-4
- Molecular formula:
- C5H12O
- IUPAC Name:
- 2-methoxy-2-methylpropane
- Details on test material:
- - Name of test material (as cited in study report): DRIVERON (MTB)
- Physical state: clear liquid
- Analytical purity: 99.9%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleine weisse Russen, 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: 2.0-2.4 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 cm3
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours and 6, 8, 10 and 14 days after treatment
- Number of animals:
- 3 males and 3 females
- Details on study design:
- Rabbits subjected to MTBE under occlusive patch for 4 hours. After the exposure, the residual substance was washed out with water and the skin reaction was estimated and scored after 1, 24, 48 and 72 hours and 6, 8, 10 and 14 days according to OECD guidelines.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: primary irritation score
- Basis:
- mean
- Time point:
- other: 1-72 hours
- Score:
- 5
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Moderate to severe edema and moderate erythema one hour after the end of exposure was observed. The effects lasted the first 8 days of the 14 days of observation.
Applicant's summary and conclusion
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