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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 807-534-0 | CAS number: 1228284-89-6
- 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-12-02 until 2015-06-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out in accordance with OECD guideline 438 and in cimpliance with GLP. The validity criteria have been fulfilled.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-(2,4,6-trichlorophenyl)acetone O-methyloxime
- EC Number:
- 807-534-0
- Cas Number:
- 1228284-89-6
- Molecular formula:
- C10H10Cl3NO
- IUPAC Name:
- 1-(2,4,6-trichlorophenyl)acetone O-methyloxime
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Brown liquid
- Purity test date: 25 September 2013
- Expiration date of the lot/batch: End September 2015
- Stability under test conditions: Stable until end September 2015
- Storage condition of test material: Room temperature (<30°C), protected from light and humidity
Constituent 1
Test animals / tissue source
- Species:
- other: Isolated chicken eye
- Strain:
- other: ROSS 308
- Details on test animals or tissues and environmental conditions:
- EYES
- Source: Commercial abattoir
EXPERIMENTAL DATES: 2 December 2013
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Yes (0.9% sodium chloride solution)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL - Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- 240 minutes. The negative and positive control eyes and all test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse. Corneal thickness and corneal opacity were measured at all time points. Fluorescein retention was measured on two occasions, at base line (t=0) and approximately 30 minutes after the post-treatment rinse.
- Number of animals or in vitro replicates:
- 7 isolated eyes (3 test item, 3 positive control, 1 negative control)
- Details on study design:
- METHOD
- After the zero reference measurements, the eye was held in a horizontal position and 30 μL of test item was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated in a similar way with 30 μL benzalkonium chloride 5 % (w/v). The negative control eye was treated with 30 μL of sodium chloride (0.9% solution). Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (pitting or loosening of the epithelium) evaluated.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 10 second exposure period, the cornea surface was rinsed thoroughly with 20 mL isotonic saline at ambient temperature.
SCORING SYSTEM:
- Corneal thickness or swelling. Measurements made with an optical pachymeter on a slit-lamp microscope and expressed as a percentage calculated from corneal thickness measurements. Corneal swelling was classified by the following scale: Mean cornea swelling (%) of 0-5, >5-12, >12-18 (>75 mins after treatment), >12-18 (<75 mins after treatment), >18-26, >26-32 (>75 mins after treatment), >26-32 (<75 mins after treatment), >32 classified as ICE Class I, II, II, III, III, III, IV or IV, respectively. i.e. No swelling = Class I, slight swelling = Class II, moderate swelling = Class III, severe swelling = Class IV.
- Corneal opacity. Corneal opacity was scored (on a 0-4 scale) using the area of the cornea that was most densely opacified and the mean ΔCOmax (mean value of the highest opacity scores) calculated. Mean maximum opacity scores of 0-0.5, 0.6-1.5, 1.6-2.5 and 2.6-4.0 were classified as ICE Class I, II, III and IV, respectively. i.e. No opacity = Class I, Slight opacity = Class II, Moderate opacity = Class III, Severe or total opacity = Class 4.
- Fluorescein retention: Fluorescein retention change was calculated and scored using a 0-3 scale. Mean fluorescein retention scores of 0-0.5, 0.6-1.5, 1.6-2.5 and 2.6-3.0 were classified as ICE Class I, II, III and IV, respectively. i.e. No fluorescein retention = Class I, slight fluorescein retention = Class II, Moderate fluorescein retention = Class III, Severe fluorescein retention = Class IV.
TOOL USED TO ASSESS SCORE: Hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Mean maximum corneal swelling
- Basis:
- mean
- Time point:
- other: up to 75 minutes
- Score:
- 0
- Remarks on result:
- other: ICE Class I
- Irritation parameter:
- other: Mean maximum corneal swelling
- Basis:
- mean
- Time point:
- other: up to 240 minutes
- Score:
- 0
- Remarks on result:
- other: ICE Class I
- Irritation parameter:
- other: Mean maximum corneal opacity change
- Basis:
- mean
- Score:
- 0.67
- Remarks on result:
- other: ICE Class II
- Irritation parameter:
- other: Mean fluorescein retention change
- Basis:
- mean
- Score:
- 0
- Remarks on result:
- other: ICE Class I
- Irritation parameter:
- other: Overall ICE Class
- Remarks on result:
- other: 2xI, 1xII
- Irritant / corrosive response data:
- No corneal swelling or fluorescein retention was observed during the four hour observation period. Corneal opacity (severity 0.5 or 1) was noted in all eyes. No other corneal effect was observed. The negative and positive control group results demonstrate that the study was valid.
The test item is non-irritating, GHS Classification: Non-classified.
The positive control benzalkonium chloride 5% (w/v) was classed as severely irritating, GHS Classification: Category 1.
The negative control Saline (NaCl 0.9% w/v) was classed as non-irritating, GHS Classification: Non-classified.
Any other information on results incl. tables
Table 1: Mean values of the treated eyes for maximum corneal thickness change, corneal opacity change and fluorescein retention change – Run 1
Observation |
Test item |
Positive control |
Negative control |
|||
Value |
ICE Class |
Value |
ICE Class |
Value |
ICE Class |
|
Mean maximum corneal swelling at up to 75 min |
0% |
I |
0% |
I |
0% |
I |
Mean maximum corneal swelling at up to 240 min |
0% |
I |
-5.3% |
II |
0% |
I |
Mean maximum corneal opacity change |
0.67 |
II |
4.00 |
IV |
0 |
I |
Mean fluorescein retention change |
0 |
I |
2.83 |
IV |
0 |
I |
Other Observations |
None |
Loosening of epithelium observed in all eyes (3/3) 75 mins after post-treatment rinse. |
None |
|||
Overall ICE Class |
2xI 1xII |
1xII 2xIV |
3xI |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information: non-irritant
- Conclusions:
- Based on this in vitro eye irritation study in isolated chicken eyes, the test item is non-irritating, GHS Classification: Non-classified.
- Executive summary:
An in vitro eye irritation study was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to OECD 438 (2013). After the zero reference measurements, the eye was held in a horizontal position and 30 μL of test item was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated in a similar way with 30 μL benzalkonium chloride 5 % (w/v). The negative control eye was treated with 30 μL of sodium chloride (0.9% solution). Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (pitting or loosening of the epithelium) evaluated.
No corneal swelling or fluorescein retention was observed during the four hour observation period. Corneal opacity (severity 0.5 or 1) was noted in all eyes. No other corneal effect was observed. The negative and positive control group results demonstrated that the study was valid.
Based on this in vitro eye irritation study in isolated chicken eyes, the test item is non-irritating, GHS Classification: Non-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.