Registration Dossier
Registration Dossier
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EC number: 271-240-3 | CAS number: 68526-92-1 A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isotridecanal from the hydroformylation of dodecene. It consists predominantly of C10-12 olefins and paraffins and C13 alcohols and aldehydes and boils in the range of approximately 160°C to 253°C (320°F to 487°F).
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- Eye irritation in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- between 26 August 2008 and 04 September 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affcet the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).
Test material
- Reference substance name:
- Dodecene, hydroformylation products, low-boiling
- EC Number:
- 271-240-3
- EC Name:
- Dodecene, hydroformylation products, low-boiling
- Cas Number:
- 68526-92-1
- Molecular formula:
- The substance consists of 46 isomers of unsaturated and branched dodecene structures (see Test Report No. A170002983).
- IUPAC Name:
- Dodecene, hydroformylation products, low-boiling
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Oxooil LS 13
- CAS no.: 68526-92-1
- Physical state: clear colourless liquid
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: 12 to 20 weeks old.
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) followed twelve hours darkness.
IN-LIFE DATES: From: day 1 To: day 3
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted and used as supplied
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 3 animals were tested in total (After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not applicable
SCORING SYSTEM:
Draize Scale
TOOL USED TO ASSESS SCORE: None
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects observed.
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: No effects observed.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No effects observed.
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of Opacity
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects observed.
- Irritation parameter:
- cornea opacity score
- Remarks:
- Area of |Cornea involved
- Basis:
- mean
- Remarks:
- results for 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects observed.
- Irritant / corrosive response data:
- No irreversible eye damage was observed.
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation.
All treated eyes appeared normal at the 48-hour observation. - Other effects:
- All animals showed expected gain in bodyweight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)
- Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC
Result. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48-hour observation.
Conclusion. This substance is not classified as an eye irritant.
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