Registration Dossier
Registration Dossier
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EC number: 216-653-1 | CAS number: 1634-04-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: non-GLP guideline study, no restrictions, fully 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 405 (Acute Eye Irritation / Corrosion)
- 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 / tissue source
- Species:
- rabbit
- Strain:
- other: Kleine weisse Russen, Chbb-SPF
- Details on test animals or tissues 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the unexposed left eye of the animals
- Amount / concentration applied:
- 0.1 cm3
- Duration of treatment / exposure:
- once, without washing
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and 6, 8, 10 and 14 days after treatment
- Number of animals or in vitro replicates:
- 3 males and 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects were seen at all
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects were observed at all
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- Only slight redness of the conjuctiva was observed. MTBE was not irritating for the eyes in this study.
Applicant's summary and conclusion
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