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EC number: 261-245-9 | CAS number: 58430-94-7
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The negative response observed in the animal treated with undiluted substance was not confirmed by testing 2 additional animals.
- Principles of method if other than guideline:
- The method used to assess eye irritancy is a modification of that prescribed for purposes of the United States Federal Hazardous Substances Labelling Act. In addition corneal damage is also assessed objectively by measurement of corneal swelling.
3 rabbits were treated with 100 µL of a 10 % dilution, 1 rabbit was treated with 100 µL of a 50 % dilution and 1 rabbit was treated with 100 µL undiluted substance. No additional rabbits were tested to confirm the negative results observed for the undiluted substance. - GLP compliance:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylhexyl acetate
- EC Number:
- 261-245-9
- EC Name:
- 3,5,5-trimethylhexyl acetate
- Cas Number:
- 58430-94-7
- Molecular formula:
- C11H22O2
- IUPAC Name:
- .
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: commercial supplier
- Age at study initiation: >= 7 weeks
- Weight at study initiation: >= 1 kg
- Housing: singly in cages from which all hay, straw or similar potentially irritant material is excluded
- Water: ad libitum
- Acclimation period: yes, duration not reported
Test system
- Vehicle:
- other: Tween 80
- Controls:
- other: Left eye served as untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 µL
- Concentration: 10 % (3 rabbits), 50 % (1 rabbit), 100 % (1 rabbit) - Observation period (in vivo):
- Conjunctival damage: 15 minutes after treatment
Corneal, conjuntival and iridial reaction: 1, 2, 3, 4, 7, 9, 11, 16, 18 and 21 days after treatment. The assessment is stopped earlier if the eye returned to normal. - Number of animals or in vitro replicates:
- Unchanged substance: 1 rabbit
50 % in Tween 80: 1 rabbit
10 % in Tween 80: 3 rabbits - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM:
CORNEA
0: Normal
0.5: Any change form normal, including slight dulling of corneal lustre
1: Scattered or diffuse areas of opacity, or loss of corneal epithelium. Iris clearly visible
2: Easily discernible, greyish, translucent areas, details of iris slightly obscured
3: Grey-white areas, no details of iris visible, size of pupil barely discernible
4: Complete corneal opacity, iris not discernible
IRIS
0: Normal
+: Any divergence from normal, congestion of iridial vessels, deepening of folds
++: Severe congestion of iridial vessels or deepening of folds. Loss of iridial reflex to light
AREA OF CORNEA OR IRIS AFFECTED
1: Less than 1/4 of area affected
2: Between 1/4 and 1/2 of area affected
3: Between 1/2 and 3/4 of area affected
4: Between 3/4 and whole area affected
CONJUNCTIVAE
Redness (palpebral and bulbar conjunctivae and nictitating membrane)
0: Vessels normal
1: Some vessels definitely injected
2: Diffuse, crimson red, individual vessels not easily discernible
3: Diffuse, beefy red
Chemosis
0: No swelling
1: Any swelling above normal
2: Obvious swelling with partial eversion of eyelids
3: Swelling with lids about half closed
4: Swelling with lids more than half closed
Discharge
0: No discharge
1: Any discharge different from normal
2: Discharge with moistening of lids and hairs just adjacent to the lids
3: Discharge with moistening of lids and considerable area round eye
TOOL USED TO ASSESS SCORE: hand torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 100 µL undiluted test substance
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 100 µL undiluted test substance
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: 100 µL undiluted test substance
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 5 days
- Remarks on result:
- other: 100 µL undiluted test substance
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: 100 µL 50 % in Tween 80
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 100 µL 50 % in Tween 80
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: 100 µL 50 % in Tween 80
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: 100 µL 50 % in Tween 80
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: 100 µL 10 % Tween 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 100 µL 10 % Tween 80
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: 100 µL 10 % Tween 80
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: 100 µL 10 % Tween 80
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the scores obtained for the undiluted substance, the substance has a low potential to be irritating to the eyes. However, it has to be considered that only one animal was dosed with undiluted substances instead of three as instructed in OECD TG 405.
- Executive summary:
The potential of 3,5,5 -trimethylhexyl acetate to induce eye irritation was tested in a screening test performed according to the modified Federal Hazardous Substances Labelling Act method. Three rabbits were treated with 100 µL of a 10% dilution of the substance in Tween 80, one rabbit was treated with 100 µL of a 50% dilution in Tween 80 and one rabbit with 100 µL undiluted substance. In the eyes treated with 10% dilution, only slight superficial corneal imperfections were caused that persisted for three to five days. Conjunctivitis was also slight and persisted for two to four days. In the eye treated with 50% dilution, a loss of 1/4 or corneal epithelium was seen, with slight corneal swelling. Corneal repair was complete after 5 days and the moderate conjuntivitis with oedema also healed after 5 days. In the eye treated with undiluted substance, the cornea remained unaffected. Only slight conjunctivitis was seen which persisted for four days.
The numerical grading of the ocular lesions was equivalent to the grading suggested in OECD TG 405. The mean of the cornea, iris and chemosis scores at 24, 48 and 72 h was below 1 in all animals and the mean of the conjunctivae scores at 24, 48 and 72 h was below or equal to 1.
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