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EC number: 238-056-5 | CAS number: 14205-39-1
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 November 1999 - 1 December 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Feb. 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- solid
- Details on test material:
- Expiry date: 21 May 2000
Batch: 624
Constituent 1
- Specific details on test material used for the study:
- The test material, a crystalline solid, was stored in the dark at ambient temperature.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three male young adult New Zealand White rabbits were used. They were within the weight range 2.10-2.34 kg on arrival, and were supplied by Harlan
UK. They arrived at lnveresk on 20 October 1999.The animals were allowed to acclimatise for at least 5 days prior to commencement of the study.
The animals were housed individually in stainless cages (approximate dimensions 77 x 70 x 48 cm) with a Noryl moulded dual level interior and
perforated floor beneath which was an absorbent paper lined tray.
Each cage was supplied with an automatic watering valve and a food hopper. Mean environmental maximum and minimum temperatures were 20°C and
19°C and mean relative humidity was 44%. A 12 h light/dark cycle was in operation (light hours 0700-1900 h) with a minimum of 15 air changes per hour.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 40.1 mg, 39.2 mg and 39.5 mg
- Duration of treatment / exposure:
- 1, 24, 48 and 72 h and extended up to day 28 (to evaluate reversibility). Eyes were not rinsed.
- Observation period (in vivo):
- Examinations after 1, 24, 48 and 72 h and extended up to day 28 (to evaluate reversibility)
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- Both eyes of each rabbit were examined prior to dosing and no ocular defects were detected.
The requisite quantity of finely ground test material was instilled into the right eye using the following technique:
The test material was placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material
was dropped. The lids were then gently held together for 1-2 s. The left eye remained untreated to serve as a control.
One rabbit was treated first and observed for signs of severe irritation for 6 days after instillation. As none were noted, the remaining 2 rabbits were
treated in the same way. All the animals were checked for viability early in the morning and again as late as possible on each day. The eyes were examined using a hand held magnifier and pen torch 1, 24,
48 and 72 h after instillation of the test material. Observations were extended up to Day 28, in order to fully evaluate the reversibility of reactions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.66
- Max. score:
- 3.66
- Reversibility:
- not fully reversible within: 28 day
- Remarks:
- still grade 1
- Remarks on result:
- positive indication of irritation
- Remarks:
- stained with fluorescein
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Remarks:
- stained with fluorescein
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 1.33
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 0.66
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 1.66
- Reversibility:
- fully reversible within: 72 hours
- Remarks:
- stained with fluorescein
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 0.66
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 1.33
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- One animal (Animal 1) reacted more severely than the other two. An easily discernible translucent area of the cornea (score 2) was noted from 1 h after instillation of the test material, up to Day 28.
The area of opacity covered between a half and the whole surface of the cornea (score 3-4) up to 72 h, and covered a quarter of the cornea (score 1) up to Day 28. Iridial responses and
slight to moderate conjunctival redness were noted up to Day 6. Slight to moderate conjunctival chemosis and moderate discharge were also noted up to 72 h after instillation.
In the 2 remaining animals, scattered or diffuse areas of opacity were noted up to 48 h after instillation, covering up to a quarter of the cornea in one animal and up to three quarters in the other (score 2-3).
Iridial responses were noted in both animals up to 48 h after instillation. Slight to moderate conjunctival redness was noted in both animals, up to either 72 h or Day 6. Both animals
displayed very slight to slight conjunctival chemosis up to 72 h after instillation. Slight or moderate discharge was noted up to 24 h after instillation. - Other effects:
- A thick white patch covering the lower right third of the cornea was noted in Animal 1 from Day 9 up to Day 28.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the non-reversible effects of the one animal in a valid and reliable GLP and Guideline-conform study a classification with Eye Corr. 1; H318 is required for methyl 3-aminocrotonate.
- Executive summary:
In the eye irritation study one animal showed a prolonged and stronger reaction than the other 2. The reactions in the eye of this animal were still existent on day 28 and therefore, require classification with Eye Corr. 1; H318, respectively. All other animals within the study showed slight signs of irritation but no classification would result from this.
Based on the non-reversible effects of the one animal in a valid and reliable GLP and Guideline-conform study a classification with Eye Corr. 1; H318 is required for methyl 3-aminocrotonate.
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.
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