Registration Dossier
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EC number: 209-548-7 | CAS number: 585-07-9
- 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:
- key study
- Study period:
- 1994-01-24 until 1994-02-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- other: amendment to study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes
Test material
- Reference substance name:
- tert-butyl methacrylate
- EC Number:
- 209-548-7
- EC Name:
- tert-butyl methacrylate
- Cas Number:
- 585-07-9
- Molecular formula:
- C8H14O2
- IUPAC Name:
- tert-butyl 2-methylprop-2-enoate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (supplier): BASF
- LOT number of test material: LAB.-J.-NO. 387
- Purity: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator, exclusion of light
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions and during storage: The stability of the test substance over the study period was proved by reanalysis. The result was reported in the form of an amendment (12 January 1995). According to the analytical determination, dated December 07, the test substance was stable over the study period. The sample appeared to be homogeneous.
FORM AS APPLIED IN THE TEST
- The unchanged test substance was applicated once to the conjunctival sac of the right eyelid of the test animals.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult (not further specified)
- Weight at study initiation: 3.67 - 4.37 kg
- Housing: single housing
- Diet: Kliba Labordiaet 341, Klingenthalmuehle AG, Kauseraugst, Switzerland, about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes (per hr): not specified
- Photoperiod:12 H/12 H (6.00 a.m.- 6.00 p.m./6.00 p.m. - 6.00 a.m.)
IN-LIFE DATES: not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each tested animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- unwashed
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The substance was not washed out.
SCORING SYSTEM: Draize scoring (for more details please refer to "Any other information on materials and methods incl. tables")
TOOL USED TO ASSESS SCORE: not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The numerical scores awarded to the eye reactions elicited by the test substance are given in Table 1.
Any other information on results incl. tables
Table 1: TABULATION OF IRRITANT RESPONSE DATA FOR EACH INDIVIDUAL ANIMAL AT EACH OBSERVATION TIME AS WELL AS CALCULATION OF THE MEANS.
Animal | Reading | Opacity | Iritis | Redness | Chemosis | Symptoms |
1 | 1 h | 0 | 0 | 2 | 1 | discharge score 3; small retractions of the eye lids |
2 | 1 h | 0 | 0 | 0 | 0 | |
3 | 1 h | 0 | 0 | 1 | 0 | discharge score 1 |
1 | 24 h | 0 | 0 | 2 | 0 | small retractions of the eye lids |
2 | 24 h | 0 | 0 | 0 | 0 | |
3 | 24 h | 0 | 0 | 2 | 1 | discharge score 1 |
1 | 48 h | 0 | 0 | 2 | 0 | small retractions of the eye lids |
2 | 48 h | 0 | 0 | 0 | 0 | |
3 | 48 h | 0 | 0 | 2 | 0 | discharge score 1 |
1 | 72 h | 0 | 0 | 2 | 0 | small retractions of the eye lids |
2 | 72 h | 0 | 0 | 0 | 0 | |
3 | 72 h | 0 | 0 | 2 | 0 | discharge score 1 |
1 | 8 d | 0 | 0 | 0 | 0 | |
2 | 8 d | 0 | 0 | 0 | 0 | |
3 | 8 d | 0 | 0 | 0 | 0 | |
mean | 24 - 72 h | 0.00 | 0.00 | 1.33 | 0.11 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions chosen and considering the described findings the test substance does give indication of an irritant property to the eye.
- Executive summary:
The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed according to a OECD TG 405 conform and GLP compliant study. The unchanged test substance was applicated once to the conjunctival sac of the right eyelid of three white Vienna rabbits. Exposure to the test susbstance produced conjunctival redness in 2/3 animals by all scoring intervals (24, 48 and 72 hours). One animal showed chemosis by the 24-hour scoring interval. The findings were reversible in all animals within 8 days after application. Under the test conditions chosen and considering the described findings the test substance does give indication of an irritant property to the eye.
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