Registration Dossier
Registration Dossier
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EC number: 438-390-3 | CAS number: -
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: This study is classified as reliable without restriction because it closely followed OECD Guideline 405 and was GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Details on test material:
- - Substance type: Poly Alpha Olefin (1-decene trimer and tetramer, hydrogenated)
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: #8BU28
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature
- Other: Clear liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Clerco Research Farm
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Individual in wire mesh cages
- Diet (e.g. ad libitum): Purina Laboratory Rabbit Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 1988-03-23 To: 1988-03-31
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitres
- Concentration (if solution): Not reported - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
SCORING SYSTEM: Method of Draize (1959)
TOOL USED TO ASSESS SCORE: Gross ocular examinations only
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1 to 6
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 2
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Two animals showed signs of conjunctival erythema; for one, signs cleared up by 72 hours, while for the other, signs appeared at 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the reported results, 1-decene, tetramer, mixed with 1-decene trimer, hydrogenated was not classified as an irritant to rabbit eyes.
- Executive summary:
In a primary eye irritation study, 0.5 mL of 1 -decene, tetramer, mixed with 1 -decene trimer, hydrogenated (Undiluted) was instilled into the right eye of 6 naïve female New Zealand White rabbits for 24 hours. Eyes of the test animals were not rinsed post exposure. Animals then were observed for 72 hours and irritation was scored by the method of Draize (1959).
Two animals showed signs of conjunctival erythema; for one, signs cleared up by 72 hours, while for the other, signs appeared at 72 hours. Based on the reported results, 1 -decene, tetramer mixed with 1 -decene trimer, hydrogenated is not an eye irritant.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it closely followed OECD Guideline 405 and was GLP compliant.
This study will influence the DNEL.
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