Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 911-280-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed on 11 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection : 10 July 2012 Date of Signature : 05 February 2013
Test material
- Reference substance name:
- Pentyl salicylate
- EC Number:
- 218-080-2
- EC Name:
- Pentyl salicylate
- Cas Number:
- 2050-08-0
- Molecular formula:
- C12H16O3
- IUPAC Name:
- Pentyl 2-hydroxybenzoate
- Reference substance name:
- 2-methylbutyl salicylate
- EC Number:
- 256-972-3
- EC Name:
- 2-methylbutyl salicylate
- Cas Number:
- 51115-63-0
- Molecular formula:
- C12H16O3
- IUPAC Name:
- 2-methylbutyl 2-hydroxybenzoate
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Sponsor's identification : Amyl Salicylate
CAS number : 2050-08-0
Description : clear colourless liquid
Batch number : PE00022143
Purity : 99.99%
Date received : 03 October 2011
Expiry date : 19 August 2012
Storage conditions : room temperature in the dark
This study was scheduled to be conducted after the test item expiry date of 19 August 2012. The sponsor was therefore contacted prior to commencement of the study. The sponsor tested the test item in order to re-validate the quality of the batch with the conclusion that the quality of the batch is comparable to the specification given in the test item Technical Data Sheet originally supplied with the test item. This study therefore proceeded as scheduled.
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: bovine cornea from slaughterhouse
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST ITEM
-Amounts(s) applied (volume or weight with unit):
0.75 mL of the test item was applied to triplicate corneas.
-Concentration (if solution):
The test item was used as supplied.
VEHICLE
No vehicle used - Duration of treatment / exposure:
- The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes.
- Duration of post- treatment incubation (in vitro):
- Post-treatment incubation period of 120 minutes.
- Number of animals or in vitro replicates:
- triplicates for test item, positive and negative control.
- Details on study design:
- TEST SITE
-Area of exposure
0.75 mL of the test item was applied to triplicate corneas.
-% coverage:
The test item was topically applied to the cornea. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea.
-Type of wrap used:
None used
REMOVAL OF TEST ITEM
-Washing (if done):
At the end of the exposure period the test item was removed from the anterior chamber and each cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM without phenaol red.
-Time after start of exposure:
10 minutes post exposure
EVALUATION OF RESULTS
Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an In Vitro Irritancy Score.
Opacity Measurement-
The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting from each the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
Permeability Measurement
The corrected OD492 was calculated by subtracting the mean OD492 of the negative control corneas from the OD492 value of each treated cornea. The OD492 value of each treatment group was calculated by averaging the corrected OD492 values of the treated corneas for the treatment group.
In Vitro Irritancy Score
The following formula was used to determine the in vitro score:
In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)
Additionally, the opacity and permeability values were evaluated independently to determine whether the test item induced a response through only one of the two endpoints.
Visual Observation
The condition of the cornea was visually assessed immediately after rinsing and at the final opacity measurement.
DATA INTERPRETATION
A test item that induces an in vitro irritancy score greater than or equal to 55.1 is defined as an ocular corrosive or severe irritant.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- test item
- Value:
- 2.7
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test item induced an in vitro irritancy score of 2.7.
The corneas treated with the test item were clear post treatment and post incubation.
Any other information on results incl. tables
RESULTS
Corneal Opacity and Permeability Measurement
Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in Table 1.
Corneal Epithelium Condition
The condition of the cornea immediately after rinsing and at the final opacity measurement is given in Table 2.
The corneas treated with the test item were clear post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.
In Vitro Irritancy Score
The results are summarised as follows:
Treatment |
In Vitro Irritancy Score |
Test Item |
2.7 |
Negative Control |
2.7 |
Positive Control |
36.1 |
Criteria for an Acceptable Test
The positive control In Vitro irritancy Score was within the range of 30.9 to 67.7. The positive control acceptance criterion was therefore satisfied.
Table 1 Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD) |
In vitroIrritancy Score |
|||||
Pre-Treatment |
Post-Treatment |
Post-Incubation |
Post-Incubation-Pre‑Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
1 |
4 |
5 |
8 |
4 |
|
0.051 |
|
|
2 |
3 |
2 |
4 |
1 |
|
0.046 |
|
|
|
3 |
2 |
2 |
3 |
1 |
|
0.033 |
|
|
|
|
|
|
|
2.0* |
|
0.043+ |
|
2.7 |
|
Positive Control |
4 |
2 |
31 |
27 |
25 |
23.0 |
1.155 |
1.112 |
|
5 |
2 |
30 |
25 |
25 |
23.0 |
0.872 |
0.829 |
|
|
6 |
1 |
26 |
24 |
24 |
22.0 |
0.792 |
0.749 |
|
|
|
|
|
|
|
22.7· |
|
0.896· |
36.1 |
|
Test Item |
7 |
2 |
5 |
7 |
5 |
3.0 |
0.019 |
0.0 |
|
8 |
1 |
4 |
6 |
5 |
3.0 |
0.020 |
0.0 |
|
|
9 |
2 |
5 |
6 |
4 |
2.0 |
0.034 |
0.0 |
|
|
|
|
|
|
|
2.7· |
|
0.0· |
2.7 |
OD = Optical density * = Mean of the post incubation-pre‑treatment values + = Mean permeability · = Mean corrected value
Table 2 Corneal Epithelium Condition
Treatment |
Cornea Number |
Observation |
|
Post Treatment |
Post Incubation |
||
Negative Control |
1 |
clear |
clear |
2 |
clear |
clear |
|
3 |
clear |
clear |
|
Positive Control |
4 |
cloudy |
cloudy |
5 |
cloudy |
cloudy |
|
6 |
cloudy |
cloudy |
|
Test Item |
7 |
clear |
clear |
8 |
clear |
clear |
|
9 |
clear |
clear |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered not to be an ocular corrosive or severe irritant.
- Executive summary:
Introduction. A study was performed to assess the ocular irritancy potential of the test item to the isolated bovine cornea. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 437 (2009) “Bovine Corneal Opacity and Permeability Assay”
Method. The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
Results. The in vitro Irritancy scores are summarised as follows:
Treatment
In Vitro Irritancy Score
Test Item
2.7
Negative Control
2.7
Positive Control
36.1
Conclusion. The test item was considered not to be an ocular corrosive or severe irritant.
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.