Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 217-288-0 | CAS number: 1800-91-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 25, 1995 To December, 1995.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP OECD guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
- EC Number:
- 217-288-0
- EC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
- Cas Number:
- 1800-91-5
- Molecular formula:
- C10H6F12
- IUPAC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
- Reference substance name:
- 1,6 Divinylperfluorohexane
- IUPAC Name:
- 1,6 Divinylperfluorohexane
- Test material form:
- other: Liquid
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: Cornelli s.n.c.
- Age at study initiation: 2-3 months
- Weight at study initiation: 2/3 kg
- Housing: individual caging in air conditioned room ; grill cages 62x47.5x38 cm
- Diet: GLP 2RB15 (Mucedola S.r.l. Settimo M.se)
- Water: ad libitum
- Acclimation period: at least 7 days before test start
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 50 +/-15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12h/12h (light: 7am-7pm)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Single administration, not rinsed.
- Observation period (in vivo):
- 60 min, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : No
SCORING SYSTEM: The ocular reaction has been scored according to the scale proposed by the 405 OECD guideline.
TOOL USED TO ASSESS SCORE: fluorescein
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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Cornea, iris and conjunctivae: no modification was observed in any animal and at any timepoint.
- Other effects:
- No animals died.
No clinical signs or behavioral alterations were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this test, 1,6 Divinylperfluorohexane is to be considered "non irritant" for the eye.
- Executive summary:
In an acute eye irritation study, young adult New Zealand white rabbits (3 animals) were in the conjunctival sac of the right eye of each animal exposed to 0.1 mL of the test article (1,6 Divinylperfluorohexane). The eye was observed at 1, 24, 48 and 72 hours after the test application. No animals died. No clinical signs or behavioral alterations were noted. No modification of cornea, iris and conjunctivae was observed in any animal. The test article, when administered by ocular route to rabbits under the experimental conditions adopted, is to be considered "non irritant" for the eye.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
