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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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:
- Experimental start date: 11 February 2016 Experimental completion date: 11 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The Rabbit Enucleated Eye Test
- Version / remarks:
- The Rabbit Enucleated Eye Test has been included in evaluations of the validity of eye irritancy test methods, but is not currently considered to be a validated 'stand-alone' test method. No formally adopted test guideline is available, but a protocol has been proposed which was based upon the method detailed in this document (ICCVAM, 2006 and 2009).
A positive result in the rabbit enucleated eye test is accepted within the EU as an indication of severe eye irritancy potential without the need for confirmation in a rabbit eye irritation test (European Chemicals Bureau, 2006). - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: yellow semi-solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Envigo RMS (UK) Limited, Leicestershire, UK. At the start of the study the animals were 12 to 20 weeks old. Rabbits that have previously been used in skin or eye irritation studies at the test facility may. be used as eye donors. If the donor animals have been used in an eye irritation study, only the untreated eyes were used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- For the purpose of the study the test item was used as supplied.
- Controls:
- yes
- yes, concurrent no treatment
- Amount / concentration applied:
- Three eyes were treated with the test item. Two additional eyes remained untreated for control purposes. The treatment eye was removed from the superfusion apparatus whilst still being held in the perspex clamp. The clamp/eye was then placed horizontally into a petri dish.
The test item was used undiluted as supplied.
A volume of 0.1 mL of the test item was applied as evenly as possible to the surface of the cornea - Duration of treatment / exposure:
- After ten seconds the test item was washed off the cornea using a minimum of 20 mL of 0.9% saline solution (pre-warmed to approximately 32 °C).
Immediately following washing of the corneal surface, the treated eye was returned to the superfusion chamber and the saline drip repositioned to irrigate the eye.
The untreated eyes were similarly washed and used for control purposes. - Duration of post- treatment incubation (in vitro):
- Immediately following washing of the corneal surface, the treated eye was returned to the superfusion chamber and the saline drip repositioned to irrigate the eye.
- Number of animals or in vitro replicates:
- 5 eyes
- Details on study design:
- Please see below
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Remarks:
- Mean Corneal Swelling
- Run / experiment:
- 60 runs
- Value:
- 31.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Remarks:
- Mean Corneal Swelling
- Run / experiment:
- 120 runs
- Value:
- 54.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Remarks:
- Mean Corneal Swelling
- Run / experiment:
- 240 runs
- Value:
- 90
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Corneal Opacity
Individual scores for corneal opacity are given in the attached Appendix 1.
Some loss of transparency was noted in all test eyes. No corneal effects were noted in the control eyes during the study period.
Corneal Thickness
Individual and mean measurements for corneal thickness are given in the attached Appendix 2. The determination of corneal swelling is given in Table 1 and Table 2. The calculated mean corneal swellings are given in Table 3.
Corneal swelling of the test eyes was considerably greater than that observed in the control eyes over the same period and exceeded the 2.25% cut-off value.
Corneal Condition
The condition of the corneal epithelium following treatment is given in the attached Appendix 3.
Sloughing of the corneal epithelium was noted in test eyes. The condition of the corneal epithelium of the control eyes appeared normal during the study.
Fluorescein Uptake
Individual scores for fluorescein uptake are given in the attached Appendix 4.
Fluorescein uptake was noted in the test eyes 240 minutes following test item application. No fluorescein uptake was noted in the control eyes 240 minutes following treatment.
Table 1 Determination of Corneal Swelling-Test Eyes
Chamber Number |
Observation Period (minutes) |
Mean Corneal Thickness(µm) |
Corneal Swelling(%)a |
Chamber Number |
Observation Period (minutes) |
Mean Corneal Thickness(µm) |
Corneal Swelling(%)a |
Chamber Number |
Observation Period (minutes) |
Mean Corneal Thickness(µm) |
Corneal Swelling(%)a |
IA |
Post equilibration |
355.8 |
na |
3A |
Post equilibration |
400.0 |
na |
5A |
Post equilibration |
414.2 |
na |
60 Post treatment |
520.2 |
46.2 |
60 Post treatment |
514.0 |
28.5 |
60 Post treatment |
493.8 |
19.2 |
|||
120 Post treatment |
643.8 |
80.9 |
120 Post treatment |
578.4 |
44.6 |
120 Post treatment |
573.6 |
38.5 |
|||
180 Post treatment |
771.6 |
116.9 |
180 Post treatment |
612.8 |
53.2 |
180 Post treatment |
633.8 |
53.0 |
|||
240 Post treatment |
854.0 |
140.0 |
240 Post treatment |
655.4 |
63.9 |
240 Post treatment |
688.6 |
66.2 |
a = % corneal swelling = (mean corneal thickness post-treatment) - (mean corneal thickness post equilibration) / mean corneal thickness post equilibrium x 100
Na = Not applicable
Table2 Determination of Corneal Swelling - Control Eyes
ChamberNumber |
Observation Period (minutes) |
Mean Corneal Thickness (µm) |
Corneal Swelling(%)a |
Chamber Number |
Observation Period(minutes) |
Mean Corneal Thickness (µm) |
Corneal Swelling(%)a |
2A |
Post equilibration |
353.0 |
na |
4A |
Post equilibration |
403.8 |
na |
60 Post treatment |
368.4 |
4.4 |
60 Post treatment |
449.8 |
11.4 |
||
120 Post treatment |
356.4 |
1.0 |
120 Post treatment |
472.6 |
17.0 |
||
180 Post treatment |
350.4 |
0.0 |
180 Post treatment |
468.4 |
16.0 |
||
240 Post treatment |
348.6 |
0.0 |
240 Post treatment |
466.6 |
15.6 |
a = % corneal swelling = (mean corneal thickness post-treatment) - (mean corneal thickness post equilibration) / mean corneal thickness post equilibrium x 100
Na = Not applicable
Table3 Mean Corneal Swelling
|
Time After Treatment |
||
60 minutes |
120 minutes |
240 minutes |
|
Test Eyes |
31.3+ |
54.7+ |
90.0+ |
Control Eyes |
7.9 |
9.0 |
7.8 |
+ = Meets or exceeds cut-off value indicating a severe ocular irritant
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Following assessment of the data for all endpoints, the test item was considered to have the potential to cause severe ocular irritancy in viva.
- Executive summary:
Introduction
Itis a legal and ethical duty under the Animals (Scientific Procedure) Act 1986 that, in the interest of animal welfare, the unnecessary use of animals is avoided, and that any testing which is likely to produc esevere responses in animals is minimized.
Therefore, before in vivo irritation testing is performed, all existing information on the test item, or its analogues should be reviewed. Available information indicated that the test item had the potential to produce severe effects in a rabbit eye and to confirm this initial assessment, a Rabbit Enucleated Eye Test (REET) was performed.
This step-wise procedure is in accordance with OECD Test Guideline 405,UK Home Office regulations and Envigo Research Limited Ethical Testing Strategy.
A study was performed to assess the ocular irritancy potential of the test item in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test item in man.
Method
0.1 mL of the test item was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32 ±1.5 °C within the superfusion chamber. A further two enucleated eyes remained untreated for control purposes.
Results
Maximal ocular irritation observations recorded for the test eyes were as follows:
Corneal Opacity
FluoresceinUptake
Mean Corneal Swelling(%)
Condition of Corneal Epithelium
Test Eyes a
Control Eyes b
Cldy x Area
Int x Area
60
ruins
120
ruins
240
ruins
60
ruins
120
ruins
240
ruins
3
4+
31.3+
54.7+
90.0+
7.9
9.0
7.8
sloughing+
a= For each time point the swelling recorded is the mean of three eyes
b= For each time point the swelling recorded is the mean of two eyes
Cldy = Corneal cloudiness
Int= Intensity of fluoresceinuptake
mms = Minutes following treatment
+= Meets or exceeds cut-off value indicating a severe ocular irritant
Conclusion
Following assessment of the data for all endpoints the test item was considered to have the potential to cause severe ocular irritancy in vivo.
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.