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EC number: 241-624-5 | CAS number: 17639-93-9
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was based on EEC methodology and performed at a reputable testing facility, however no information on GLP was provided in the test report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Report states study was in accordance with EEC methodology, however no specific method was cited.
- GLP compliance:
- not specified
- Remarks:
- No information on GLP was provided
Test material
- Reference substance name:
- 2-chloropropionic acid methyl ester
- IUPAC Name:
- 2-chloropropionic acid methyl ester
- Details on test material:
- - Name of test material (as cited in study report): Methyl ACPA/ 2-Chloropropionic acid methyl ester
- Physical state: Liquid
- Analytical purity: 99.4%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1 screen animal and 3 test animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 72 hour observation period
- Score:
- 1.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hour observation period
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hour observation period
- Score:
- 1.65
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hour observation peiod
- Score:
- 1.77
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
The details of the results are tabulated below.
Table 1.
Rabbit Number and Sex |
Region of Eye |
One Hour |
Day after Instillation |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||||
2966* Male |
Cornea |
Density |
0 |
0 |
0 |
0 |
|
|
|
|
Area |
0 |
0 |
0 |
0 |
|
|
|
|
||
Iris |
0 |
0 |
0 |
0 |
|
|
|
|
||
Conjunctiva |
Redness |
2 |
2 |
2 |
0 |
|
|
|
|
|
Chemosis |
1 |
1 |
1 |
0 |
|
|
|
|
||
2967 Male |
Cornea |
Density |
1 |
1 |
2 |
2 |
2 |
2 |
1 |
0 |
Area |
3 |
3 |
1 |
2 |
2 |
1 |
1 |
0 |
||
Iris |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
2 |
2 |
2 |
3 |
2 |
2 |
1 |
0 |
|
Chemosis |
1 |
3 |
3 |
3 |
3 |
1 |
0 |
0 |
||
590 Female |
Cornea |
Density |
4 |
2 |
1 |
1 |
1 |
0 |
|
|
Area |
1 |
2 |
1 |
1 |
1 |
0 |
|
|
||
Iris |
|
0 |
1 |
0 |
0 |
0 |
0 |
|
|
|
Conjunctiva |
Redness |
2 |
2 |
2 |
1 |
1 |
0 |
|
|
|
Chemosis |
1 |
2 |
1 |
1 |
0 |
0 |
|
|
||
418 Female |
Cornea |
Density |
2 |
2 |
1 |
1 |
0 |
0 |
|
|
Area |
1 |
1 |
1 |
1 |
0 |
0 |
|
|
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
Conjunctiva |
Redness |
1 |
1 |
1 |
1 |
1 |
0 |
|
|
|
Chemosis |
1 |
1 |
1 |
1 |
1 |
0 |
|
|
* Screen animal - eye rinsed 30 seconds after dosing.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Instillation of Methyl ACPA into the rabbit eye produced corneal lesions (up to grade 4 opacification), inflammation of the iris (grade 1) and moderate conjunctival irritation.
- Executive summary:
The eye irritation effect of methyl-2-chlorpropionic acid was evaluated in a study performed in accordance with EEC methodology. Methyl-2-chloropropionic acid (0.1ml) was dosed into one eye of each of four rabbits.
One animal was treated in advance of the others as a screen; the eye of this animal only was washed for 30 seconds after 30 seconds exposure. The treated eyes were assessed for up to 21 days after treatment.
Instillation of the test substance into the rabbit eye produced corneal lesions (up to grade 4 opacification), inflammation of the iris (grade 1) and moderate conjunctival irritation.
Although the observed effects are not sufficient to trigger a classification requirement as ‘irritating to eyes’ according to CLP criteria, the classification listed under Annex VI of Regulation (EC)1272/2008 includes classification for eye irritation.
In view of this, the registrant adopts the classification 'Eye Irritant 2' as listed in Annex VI.
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