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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 309-363-2 | CAS number: 100231-63-8
- 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:
- weight of evidence
- Study period:
- 03 Feb 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 guidelineopen allclose all
- 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)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM, Medicines & Healthcare products Regulatory Agency
Test material
- Reference substance name:
- Pentyl D-glucoside
- EC Number:
- 309-363-2
- EC Name:
- Pentyl D-glucoside
- Cas Number:
- 100231-63-8
- Molecular formula:
- (C6H10O5)nC5H12O, n - number of D-glucopyranose units
- IUPAC Name:
- (2R,3S,4S,5R,6R)-2-(hydroxymethyl)-6-{[(2R,3S,4S,5R,6R)-3,4,5-trihydroxy-6-(pentyloxy)oxan-2-yl]methoxy}oxane-3,4,5-triol; (2S,3R,4R,5S,6S)-2-(hydroxymethyl)-6-(pentyloxy)oxane-3,4,5-triol
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: local abattoir
- Characteristics of donor animals: adult animals (typically 12 to 60 months old)
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Isolated eyes were stored in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 μg/mL). They were transported to the test facility over ice packs on the same day of slaughter.
- Time interval prior to initiating testing: The corneas were refrigerated on arrival and used within 24 hours of receipt.
- indication of any existing defects or lesions in ocular tissue samples: All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
- Indication of any antibiotics used: penicillin at 100 IU/mL and streptomycin at 100 μg/mL
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.75 mL
NEGATIVE CONTROL
- Amount(s) applied: 0.75 mL
POSITIVE CONTROL
- Amount(s) applied: 0.75 mL
- Purity: > 99.8% - Duration of treatment / exposure:
- 10 min at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 120 min at 32 ± 1 °C
- Number of animals or in vitro replicates:
- triplicates for each treatment and control groups
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed in a dish containing Hanks’ Balanced Salt Solution (HBSS) until they were mounted in special BCOP holders. The anterior and posterior chambers of each BCOP holder were filled with complete Eagle’s Minimum Essential Medium (EMEM) without phenol red and plugged. The holders were incubated at 32 ± 1 ºC for 60 minutes.
QUALITY CHECK OF THE ISOLATED CORNEAS
At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used. A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer. The average opacity for all corneas was calculated. Three corneas with opacity values close to the median value of all corneas were allocated to the negative and positive control as well as to the test item.
APPLICATION DOSE AND EXPOSURE TIME
The EMEM was removed from the anterior chamber of the BCOP holder and 0.75 mL of the test item or control items were applied to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 10 minutes.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 4
- POST-EXPOSURE INCUBATION: Test item and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red. The anterior chamber was refilled with fresh complete EMEM without phenol red. The holders were incubated, anterior chamber facing forward, at 32 ± 1 ºC for 120 minutes.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The change in opacity for each cornea was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting 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.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of Anthos 2001 microplate reader (OD492)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS) :
In Vitro Irritancy Score (IVIS) = mean opacity value + (15 x mean permeability OD492 value)
DECISION CRITERIA:
Test substance with an IVIS > 55 was regarded as severe irritant/corrosive and labelled Category 1.
Test substance with an IVIS ≤ 3 was regarded as non-irritant and labelled in no category.
Test substance with an IVIS > 3; ≤ 55: no prediction can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 21.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
The corneas treated with the test item were cloudy 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.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, opacity = 2.7, permeability = 0.030 (criterion: opacity ≤ 2.8 and permeability ≤ 0.115)
- Acceptance criteria met for positive control: yes, IVIS = 43.3 (criterion: IVIS within two standard deviations of the historical mean collated during 2015 for this testing facility [IVIS 27.2 to 53.4])
Any other information on results incl. tables
Table 1: Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea number |
Opacity |
Permeability (OD) |
In Vitro Irritancy Score (IVIS) |
|||||
Pre-Treatment |
Post-Treatment |
Post-Incubation |
Post-Incubation – Post-Treatment |
Corrected value |
|
Corrected value |
|||
Negative control |
10 |
3 |
4 |
6 |
3 |
|
0.052 |
|
|
12 |
4 |
5 |
6 |
2 |
|
0.016 |
|
|
|
14 |
4 |
4 |
7 |
3 |
|
0.021 |
|
|
|
|
|
|
|
2.7* |
|
0.030** |
|
3.1 |
|
Positive control |
11 |
2 |
25 |
29 |
27 |
24.3 |
1.336 |
1.306 |
|
13 |
5 |
28 |
31 |
26 |
23.3 |
1.319 |
1.289 |
|
|
15 |
2 |
31 |
30 |
28 |
25.3 |
1.256 |
1.226 |
|
|
|
|
|
|
|
24.3*** |
|
1.274*** |
43.4 |
|
Test item |
16 |
5 |
16 |
22 |
17 |
14.3 |
0.798 |
0.768 |
|
17 |
5 |
16 |
21 |
16 |
13.3 |
0.418 |
0.388 |
|
|
18 |
3 |
14 |
18 |
15 |
12.3 |
0.480 |
0.450 |
|
|
|
|
|
|
|
13.3*** |
|
0.536*** |
21.4 |
OD = Optical density
*: Mean of the post-incubation – pre-treatment values
**: Mean permeability
***: Mean corrected value
Applicant's summary and conclusion
- Interpretation of results:
- other: no prediction of eye irritation can be made
- Conclusions:
- Under the conditions of this in vitro Bovine Corneal Opacity and Permeability Test (BCOP), the test item caused an increase of the corneal opacity and of the permeability above the values characteristic for substances not requiring classification as eye irritants according to the criteria of Regulation (EC) No. 1272/2006 (CLP). The calculated mean in vitro irritancy score (IVIS) was 21.4. However, the values determined are not sufficiently high to indicate the test item to cause serious eye damage. In conclusion, no prediction of the eye irritation potential of the test item can be made and further data are required.
The test item was shown to have an irritating or corrosive potential towards reconstructed human epidermis tissue. Moreover, in a Bovine Corneal Opacity and Permeability Test capable of identifying substances that can induce serious eye damage and substances not requiring classification for eye irritation or serious eye damage, no prediction could be made for the registered substance. In conclusion, accounting for both in vitro investigations in a Weight-of-Evidence approach, the registered substance is considered to meet the criteria for classification as Eye Irrit. 2, H319, according to the CLP Regulation (EC) No. 1272/2008.
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.