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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-279-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- rel-(3R,3aS,7S,8aS)-3,6,8,8-tetramethyl-2,3,4,7,8,8a-hexahydro-1H-3a,7-methanoazulene
- Cas Number:
- 22567-43-7
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(3R,3aS,7S,8aS)-3,6,8,8-tetramethyl-2,3,4,7,8,8a-hexahydro-1H-3a,7-methanoazulene
- Reference substance name:
- rel-(3R,3aR,7R,8aS)-3,8,8-trimethyl-6-methyleneoctahydro-1H-3a,7-methanoazulene
- Cas Number:
- 1404220-60-5
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(3R,3aR,7R,8aS)-3,8,8-trimethyl-6-methyleneoctahydro-1H-3a,7-methanoazulene
- Reference substance name:
- rel-(3R,3aS,7S,8aS)-3,8,8-trimethyl-6-methyleneoctahydro-1H-3a,7-methanoazulene
- Cas Number:
- 65450-98-8
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(3R,3aS,7S,8aS)-3,8,8-trimethyl-6-methyleneoctahydro-1H-3a,7-methanoazulene
- Reference substance name:
- rel-(1R,9S,E)-4,11,11-trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene
- Cas Number:
- 17627-40-6
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1R,9S,E)-4,11,11-trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene
- Reference substance name:
- rel-(1aR,4aR,8aR)-2,4a,8,8-tetramethyl-1,1a,4,4a,5,6,7,8-octahydrocyclopropa[d]naphthalene
- Cas Number:
- 32435-95-3
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1aR,4aR,8aR)-2,4a,8,8-tetramethyl-1,1a,4,4a,5,6,7,8-octahydrocyclopropa[d]naphthalene
- Reference substance name:
- 1,8-dimethyl-4-(propan-2-ylidene)spiro[4.5]dec-7-ene
- Molecular formula:
- C15H24
- IUPAC Name:
- 1,8-dimethyl-4-(propan-2-ylidene)spiro[4.5]dec-7-ene
- Reference substance name:
- 1-methyl-4-(1,2,2-trimethylcyclopentyl)benzene
- Cas Number:
- 51773-81-0
- Molecular formula:
- C15H22
- IUPAC Name:
- 1-methyl-4-(1,2,2-trimethylcyclopentyl)benzene
- Test material form:
- liquid
- Details on test material:
- UVCB
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
- Specific details on test material used for the study:
- Batch: SH00085512
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 ul
- Duration of treatment / exposure:
- 10 +/- 1 minute
- Duration of post- treatment incubation (in vitro):
- 120 +/- 10 minutes
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 0.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The corneas treated with Cedrene Washed showed opacity values ranging from -0.5 to 0.6 and permeability values were -0.001. The corneas were clear after the 10 minutes of treatment with Cedrene Washed. No pH effect of the test item was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -0.6 to 0.6 after 10 minutes of treatment with Cedrene Washed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 61 and within two standard deviations of the current historical positive control mean (Appendix 3).
It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Cedrene Washed did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.1 after 10 minutes of treatment.
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.
