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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 270-365-0 | CAS number: 68425-65-0
- 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:
- October 04, 2017 to October 05, 2017.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Most data for the substance is provided by read-across to the similar aluminium complex aluminum, benzoate C16-18-fatty acids complexes (CAS 94166-87-7), but the Target Substance contains isopropanol, which is released from the substance during hydrolysis, and classified as an eye irritant (CLP Regulation, Annex VI and REACH disseminated dossier), so we investigated eye irritancy of the Target Substance through experimental study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 6 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant, non-guideline study, available as an unpublished report.
- Justification for type of information:
- The substance is the Source Substance of the read-across. However in this case a study was conducted on the Target Substance, because it rapidly hydrolyses giving propan-2-ol which has a classification for eye irritation in the CLP Regulation Annex VI and the REACH disseminated dossier.
- Principles of method if other than guideline:
- The rabbit enucleated eye test is used as a first stage in the assessment of ocular irritancy potential. The assay has undergone inter-laboratory validation and has been shown to reliably detect test items that are negligible, or moderate to severe ocular irritants.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- - State of eyes: Enucleated
- Selection of eyes: Prior to enucleation, the eyes of the provisionally selected rabbits were examined for evidence of ocular irritation or defect, following application of Fluorescein Sodium drops BP (1% w/v). Corneal thickness values were recorded. Only animals whose eyes showed no evidence of ocular irritation or defect were used for testing purposes (see below).
- Enucleation of eyes: Rabbits were sacrificed and two to three drops of saline solution at approximately 32°C were immediately applied to the cornea. The eye was carefully removed, positioned in a perspex clamp and placed within the superfusion chamber, with the surface irrigated by a saline drip. The eyes were then allowed to equilibrate for approximately thirty minutes, before being re examined and the corneal thickness measured. Any eyes in which the corneal swelling was greater than 10% relative to the pre-enucleation measurement, or in which the cornea was stained with fluorescein, were rejected.
- Environmental conditions: The superfusion apparatus was set to a stable temperature of 32 ±1.5°C within the chamber and a peristaltic pump supplied saline solution at approximately 32°C at a flow rate of 0.15 to 0.4 mL/minute. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL, equivalent to approximately 71 mg of the test item, was sprinkled as evenly as possible over the surface of the cornea - Duration of treatment / exposure:
- - Exposure: Ten seconds, then the test item was washed off the cornea using a minimum of 20 mL of saline solution at approximately 32°C
- Observation period (in vivo):
- - Assessment of corneal cloudiness: Assessment was made pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment
- Measurements for corneal thickness: Pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment
- The condition of the corneal epithelium: Approximately 60, 120, 180 and 240 minutes following treatment
- The uptake of fluorescein by the corneal epithelium: Pre-enucleation, post equilibration and approximately 240 minutes following treatment - Number of animals or in vitro replicates:
- - Number of eyes: Three eyes were treated with test item, two additional eyes remained untreated for control purposes.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, the test item was washed off the cornea using a minimum of 20 mL of saline solution (approximately 32 ºC)
- Time after start of exposure: Ten seconds
SCORING SYSTEM: Assessment of corneal cloudiness was made according to the numerical evaluation adopted from Advances in Modern Toxicology: Dermatoxicology, 4th Ed, (F Marzulli and H Maibach, eds) Hemisphere Publishing Corporation, Washington DC, 1991, pp 749-815.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: A slit-lamp biomicroscope was used to examine the eye and the thickness of the cornea was measured using an ultrasonic pachymeter. For each enucleated eye a measurement was made at the optical centre, and at a further four locations at the apex of the cornea.
- Statistics: A mean value for corneal thickness was calculated from the values for the optical centre and the apex. - Irritation parameter:
- cornea opacity score
- Remarks:
- The mean value is given below.
- Run / experiment:
- 1
- Value:
- 0
- Remarks on result:
- other: No corneal opacities or corneal swelling observed
- Irritation parameter:
- fluorescein retention score
- Remarks:
- Fluorescein uptake. Mean value is given below.
- Run / experiment:
- 1
- Value:
- 0
- Remarks on result:
- other: No Fluorescein uptake noted 240 minutes after treatment
- Other effects / acceptance of results:
- Corneal opacity: No corneal effects were noted in the test eyes or control eyes during the study period.
Corneal thickness: Corneal swelling of the test eyes during the study period was comparable to that observed in the control eyes over the same period.
Corneal condition: The condition of the corneal epithelium of the test eyes and control eyes appeared normal during the study period.
Fluorescein uptake: No fluorescein uptake was noted in the test eyes or control eyes 240 minutes after treatment.
Conclusion: Following assessment of the data for all endpoints, the test item was considered unlikely to have the potential to cause severe ocular irritancy in vivo. - Conclusions:
- No corneal effects or fluorescein uptake were noted, corneal swelling of the test eyes was comparable to the control eyes and the condition of the corneal epithelium appeared normal. Following assessment of the data for all endpoints, aluminum, benzoate C16-18-fatty acids complexes was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
- Executive summary:
Aluminum, benzoate C16-18-fatty acids complexes was considered unlikely to have the potential to cause severe ocular irritancy in vivo. The occular irritation potential of test item was assessed in a GLP-compliant, non-guideline study on enucleated rabbit eyes (Harlan 2013). The test item was applied to the cornea of three enucleated rabbit eyes maintained at 32°C in a superfusion chamber and maximal ocular irritation observations were recorded at 60, 120 and 240 minutes, for corneal opacity, fluorescein uptake and condition of the corneal epithelium. The study is considered reliable and relevant for use for this endpoint.
Table1 Individual Scores for Corneal Opacity
Test Eyes
Control Eyes
Chamber Number
1
3
5
2
4
Time After Treatment (minutes)
60
120
180
240
60
120
180
240
60
120
180
240
60
120
180
240
60
120
180
240
Degree of Corneal Opacity
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Area of Corneal Opacity
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Maximum Corneal Opacity (corneal cloudiness x area)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Table2 Individual Measurements for Corneal Thickness (µm)
Test Eyes
Time After Treatment (minutes)
60
120
180
240
Corneal Position
1·
2
3
4
5
mean
1·
2
3
4
5
mean
1·
2
3
4
5
mean
1·
2
3
4
5
mean
Chamber Number
1
409
376
404
363
368
384.0
371
375
399
362
365
374.4
376
371
390
360
365
372.4
370
368
380
349
360
365.4
3
421
437
433
414
419
424.8
424
418
436
400
419
419.4
425
420
438
395
400
415.6
397
404
415
380
403
399.8
5
425
402
377
383
384
394.2
406
387
375
395
394
391.4
397
383
371
384
383
383.6
386
369
363
384
357
371.8
Control Eyes
Time After Treatment (minutes)
60
120
180
240
Corneal Position
1·
2
3
4
5
mean
1·
2
3
4
5
mean
1·
2
3
4
5
mean
1·
2
3
4
5
mean
Chamber Number
2
398
363
380
374
369
376.8
379
354
367
373
364
367.4
384
348
362
373
359
365.0
377
340
363
371
356
361.4
4
411
391
418
410
403
406.6
415
396
418
401
396
405.2
400
384
404
395
392
395.0
394
389
387
389
385
388.8
·= Optical centre
Table3 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
1
Post equilibration
372.4
N/A
3
Post equilibration
399.4
N/A
5
Post equilibration
368.4
N/A
60 Post treatment
384.0
3.1
60 Post treatment
424.8
6.4
60 Post treatment
394.2
7.0
120 Post treatment
374.4
0.5
120 Post treatment
419.4
5.0
120 Post treatment
391.4
6.2
180 Post treatment
372.4
0.0
180 Post treatment
415.6
4.1
180 Post treatment
383.6
4.1
240 Post treatment
365.4
0.0
240 Post treatment
399.8
0.1
240 Post treatment
371.8
0.9
Control 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
Test Eyes
Mean corneal swelling 1 hour following treatment 5.5%
Mean corneal swelling 2 hours following treatment 3.9%
Mean corneal swelling 4 hours following treatment 0.3%
2
Post equilibration
364.8
N/A
4
Post equilibration
392.0
N/A
60 Post treatment
376.8
3.3
60 Post treatment
406.6
3.7
Control Eyes
120 Post treatment
367.4
0.7
120 Post treatment
405.2
3.4
Mean corneal swelling 1 hour following treatment 3.5%
Mean corneal swelling 2 hours following treatment 2.0%
Mean corneal swelling 4 hours following treatment 0.0%
180 Post treatment
365.2
0.1
180 Post treatment
395.0
0.8
240 Post treatment
361.4
0.0
240 Post treatment
388.8
0.0
a = % Corneal swelling = (mean corneal thickness post-treatment) – (mean corneal thickness post equilibratiom)x 100
Mean corneal thickness post equilibration
N/A= Not applicable
Table 4 Corneal Epithelium Condition
Test Eyes
Chamber Number
Time After Treatment (minutes)
60
120
180
240
1
Normal
Normal
Normal
Normal
3
Normal
Normal
Normal
Normal
5
Normal
Normal
Normal
Normal
Control Eyes
Chamber Number
Time After Treatment (minutes)
60
120
180
240
2
Normal
Normal
Normal
Normal
4
Normal
Normal
Normal
Normal
Table 5 Individual Scores for Fluorescein Uptake (240 Minutes Post Dosing)
Test Eyes
Control Eyes
Chamber Number
1
3
5
2
4
Intensity of Fluorescein Uptake
0
0
0
0
0
Area of Fluorescein Uptake
0
0
0
0
0
Maximum Fluorescein Uptake
(intensity x area)
0
0
0
0
0
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Principles of method if other than guideline:
- Draize test.
- Specific details on test material used for the study:
- Test substance is a hydrolysis product of Target Substance.
- Species:
- rabbit
- Irritation parameter:
- overall irritation score
- Remarks:
- Study gives maximum Draize score of 37 (out of 110). Isopropanol is reported to be irritating to eyes. Harmonised classification includes Eye Irrit, Category 2.
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Irritating in rabbit test.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Isopropanol is reported to be irritating to eyes. Harmonised classification includes Eye Irrit, Category 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 28 July 2015.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Oxo(propan-2-olato)aluminium
- EC Number:
- 270-365-0
- EC Name:
- Oxo(propan-2-olato)aluminium
- Cas Number:
- 68425-65-0
- Molecular formula:
- C3 H7 Al O2
- IUPAC Name:
- oxo(propan-2-olato)aluminium
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The three-dimensional RhCE tissue construct that is produced using primary human epidermal keratinocytes i.e., EpiOcular™ OCL-200. The EpiOcular™ OCL-200 RhCE tissues construct is similar to the in vivo corneal epithelium three-dimensional structure.
Test system
- Amount / concentration applied:
- Approximately 50 mg test item was applied (each test item treated insert) topically onto the EpiOcular™ tissues.
- Duration of treatment / exposure:
- The plates with the treated tissue units were incubated for the exposure time of 6 hours (± 15 min) at standard culture conditions (37±1°C in an incubator with 5±1% CO2, 90±10% humidified atmosphere).
- Duration of post- treatment incubation (in vitro):
- After rinsing, the tissues were transferred to and immersed in 5 mL of previously warmed Assay Medium (room temperature) in a pre-labeled 12-well plate for a 25 ± 2 minute immersion incubation (Post-Soak) at room temperature. This incubation in Assay Medium was intended to remove any test item absorbed into the tissue.
At the end of the Post-Soak immersion, each insert was removed from the Assay Medium, the medium was decanted off the tissue, and the insert was blotted on absorbent material, and afterwards transferred to the appropriate well of the pre-labeled 6-well plate containing 1 mL of warm (37°C) Assay Medium. The tissues were incubated for 18 hours ± 15 minutes at standard culture conditions (Post-treatment Incubation). - Details on study design:
- The irritation potential of a chemical may be predicted by measurement of its cytotoxic effect, as reflected in the MTT assay, on the EpiOcular™ (OCL-200-EIT) tissue. The EpiOcular™ can be used to identify chemicals that do not require classification for eye irritation or serious eye damage according to the UN GHS classification system. This test method can be used to partly replace the in vivo Rabbit eye test (OECD 405), without the need to use live animals.
The three-dimensional RhCE tissue construct that is produced using primary human epidermal keratinocytes i.e., EpiOcular™ OCL-200. The EpiOcular™ OCL-200 RhCE tissues construct is similar to the in vivo corneal epithelium three-dimensional structure. In this assay, the test item is applied to the surface of the cornea epithelial construct for a fixed period, removed, and the tissue allowed to express the resulting damage. Liquids and solids are treated with different exposure and post-exposure incubations. Two construct tissues are used for each treatment and control group. Relative tissue viability is determined against the negative control-treated constructs by the reduction of the vital dye MTT (3-[4,5 - dimethylthiazol-2-yl] - 2,5 - diphenyltetrazolium bromide). A concurrent positive control is used with each assay (Kaluzhny et al., 2011).
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % Cell viability compared to negative control
- Run / experiment:
- 1
- Value:
- 18
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- The test item XP 473 showed significantly reduced cell viability in comparison to the negative control (mean relative viability: 18 %). All obtained test item viability results were below 60% when compared to the viability values obtained from the negative control.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The results obtained from this in vitro eye irritation test, using the EpiOcular™ model, with the test item XP 473 indicated that the test item is Irritant (UN GHS Category 2) and/or Corrosive (UN GHS Category 1). However, this test method (OECD 492) cannot resolve between UN GHS Categories 1 and 2. However, the irritancy is expected to be due to isopropanol released by hydrolysis of the test substance, classified in CLP Regulation Annex VI and the REACH disseminated dossier as Eye Irrit 2, and this is considered the maximum classification.
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.