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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 255-730-4 | CAS number: 42233-75-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Jul - 09 Aug 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
Test material
- Reference substance name:
- Didocosyl sebacate
- EC Number:
- 255-730-4
- EC Name:
- Didocosyl sebacate
- Cas Number:
- 42233-75-0
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Decanedioic acid, diesters with Fatty alcohols C20-22 (even numbered)
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white solid
- Storage condition of test material: room temperature in the dark
- Expiration date of the lot/batch: 30 Jun 2013
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 Laboratories UK, Ltd., Leicestershire, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2600 – 2920 g
- Housing: Animals were caged individually in suspended cages
- Diet: 2930C Teklad Global Certified Rabbit diet (Harlan Laboratories UK, Ltd., Oxon, UK), ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 3 days
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 2 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean over 2 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean over 2 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- other: mean over 2 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Neither corneal nor iris effects were noted after application with the test material during the study period. Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation period noted in the other treated eye one hour after treatment. Minimal conjunctival irritation was noted in one treated eye at the 24-hour observation time point. One treated eye appeared normal at the 24-hour observation time point abd the other treated eye appeared normal at the 48-hour observation time point.
- Other effects:
- No mortalities occured during the study period. One animal showed bodyweight loss and the other animal showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1: Individual scores for occular irritation
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
1 |
1 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
|
2
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.33 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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.
