Registration Dossier
Registration Dossier
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EC number: 295-765-2 | CAS number: 92128-68-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, available as unpublished report, performed in a reliable laboratory (BASF), signed by key scientists, no GLP certificate, but otherwise acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydrocarbons, C5, ethylene-manuf.-by-product, hydrogenated
- EC Number:
- 295-765-2
- EC Name:
- Hydrocarbons, C5, ethylene-manuf.-by-product, hydrogenated
- Cas Number:
- 92128-68-2
- Molecular formula:
- Unspecified
- IUPAC Name:
- (2E)-pent-2-ene; 2-methylbut-2-ene; 2-methylbutane; cyclopentane; cyclopentene; pentane
- Reference substance name:
- C5 produkt
- IUPAC Name:
- C5 produkt
- Details on test material:
- - C5 produkt
- no data (reported as available in the raw data)
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Savo med Versuchsteirzuchten, GMBH, FRG
- Age at study initiation: no data
- Weight at study initiation: mean: 3.18 kg
- Housing: In stainless steel wire mesh cages
- Diet: Kliba 341 (approximately 130 g per animal per day)
- Water: approximately 250 mL per animal per day
- Acclimation period: At least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes: Fully air conditioned
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: Dosed: 11 December 1989
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the eyes were not washed
SCORING SYSTEM:
- According to the 83/467/EEC criteria of July 29th 1983
- Eyes examined at 1, 24, 48 and 72 hours after application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 hours
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The overall mean score for conjunctival redness was 0.3, and for chemosis was 0.2. All eyes were normal 72 hours following instillation of the test substance.
- Executive summary:
C5 Produkt (CAS 92128 -68 -2) was non irritating to the rabbit eye and does not warrant classification under DPD or GHS/CLP.
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