Registration Dossier
Registration Dossier
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EC number: 500-004-7 | CAS number: 9003-29-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- 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, adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
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:
- Reference substance 002
- Cas Number:
- 11071-47-9
- Molecular formula:
- C8H16
- Details on test material:
- Di-n-butene. According to the report's owners the substance di-n-butene can be classified as CAS 11071-47-9 (Isooctene).
Components: 18 % n-Octene, 58 % Methylheptene and 24 % Dimethylhexene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: small, white Russian (Chbb-SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.2
- Housing: stainless steel cages
- Diet (e.g. ad libitum): K4 Alleindiat for rabbits
- Water (e.g. ad libitum): tapwater
- 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:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after application and also at 6 days after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): saline solution
- Time after start of exposure: 72 hours
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant
- Remarks on result:
- other: score also 0 at 6 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant
- Remarks on result:
- other: score also 0 at 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant
- Remarks on result:
- other: score also 0 at 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant
- Remarks on result:
- other: score also 0 at 6 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, di-n-butene was not irritating to rabbit eyes
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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