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EC number: 816-856-0 | CAS number: 5205-01-6
- 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 14 June 2021 to 3 September 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 491 (Short Time Exposure In Vitro 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 June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methyl-1,3-butanediol-1-ethylate
- EC Number:
- 816-856-0
- Cas Number:
- 5205-01-6
- Molecular formula:
- C7H14O3
- IUPAC Name:
- 3-methyl-1,3-butanediol-1-ethylate
Constituent 1
- Specific details on test material used for the study:
- 86.0% purity
IDP-AC
CAS 5205-01-6
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- Rabbit cornea (SIRC) cells
- Details on test animals or tissues and environmental conditions:
- Mycoplasma negative rabbit cornea (SIRC) cells specified in the OECD test guideline were obtained from Health Science Research Resources Bank, Japan Health Sciences Foundation. The doubling time was 18-31 hours. Cells were stored frozen in liquid nitrogen, in medium containing 10% FBS and 10% DMSO. The cell passage number was 14-16 for the three experiments.
Test system
- Vehicle:
- physiological saline
- Remarks:
- 5% w/w
- Controls:
- yes, concurrent no treatment
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 200 microlitres/well
5% (w/w)
0.05% (v/v) - Duration of treatment / exposure:
- 5 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- The test material, solvent and positive controls were tested in triplicate.
- Details on study design:
- - Number of repetitions and replicates used:
The assay was perforemd in triplicate with three independent valud repetitions. An inititial repetition was discounted as it did not meet the acceptance criteria for the positive control.
- Test chemical concentrations used:
5% (w/w), 0.055 (v/v), as specified by the OECD Test Guideline
- Justification for choice of solvent for each test chemical
Based on solubility of the test material and positive control chemicals, and compatability with the test system.
- Duration of exposure to the test chemical:
5 minutes, as specified by the OECD Test Guideline
- Description of any modifications of the test procedure:
None
- Description of evaluation and decision criteria used
Acceptability criteria:
Mean OD in the medium control group >=0.3
Cell viability of the negative control >=80% of the medium control
Cell viability of the positive control 21.1-62.3%
SD for the mean final cell viability <15% for both test material concentrations
Decision criteria:
Category 1 is assigned on the basis of mean cell viability (5% or 0.05%) <=70%
No prediction can be made on the basis of mean cell viability <=70% (5%) and >70% (0.05%)
Category 2 is assigned on the basis of mean cell viability (5% or 0.05%) >70%
- Reference to historical positive control data:
Included in the study report
- Demonstration of proficiency of the laboratory in performing the test method:
Included in the study report
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent tissue viability
- Remarks:
- (%)
- Run / experiment:
- Runs 2-4 (0.05% test material)
- Value:
- >= 90.4 - <= 114.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent tissue viability
- Remarks:
- (%)
- Run / experiment:
- Runs 2-4 (5% test material)
- Value:
- >= 65.8 - <= 92.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- All acceptance criteria were met for the three independent experiments presented. An initial experiment was rejected.
Any other information on results incl. tables
Summary of results
Group | Experiment # | Viability (%) | Mean (%) | SD (%) | |
Medium control | 2 | 100.0 |
|
|
|
3 | 100.0 | ||||
4 | 100.0 | ||||
Negative control | 2 | 97.3 | 100.0 | 96.8 | 5.1 |
3 | 91.5 | 100.0 | |||
4 | 101.7 | 100.0 | |||
Positive control | 2 |
| 38.7 | 47.2 | 9.0 |
3 | 56.6 | ||||
4 | 46.3 | ||||
5% | 2 |
| 65.8 | 76.9 | 13.9 |
3 | 72.5 | ||||
4 | 92.6 | ||||
0.05% | 2 |
| 90.4 | 104.3 | 12.6 |
3 | 107.8 | ||||
4 | 114.9 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The results of this study indicate that IPD-AC does not require classification in any GHS Category for eye irritation.
- Conclusions:
- The results of this study indicate that IPD-AC does not require classification for eye irritation according to CLP criteria.
- Executive summary:
The ability of the test material IPD-AC to cause serious eye damage or serious eye irritation was investigated in a short-term exposure (STE) assay in rabbit cornea SIRC cells, performed to GLP and OECD TG 491. The mean cell viabilities over the three independent experiments were 76.9% (5% w/w) and 104.3% (0.05% v/v). The results of this study indicate that IPD-AC does not require classification for eye irritation according to CLP criteria.
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