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EC number: 617-638-6 | CAS number: 84868-02-0
- 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:
- 17-04-1991 to 09-07-1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- OECD 1981, updated Guideline adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1's,4'r)-4'-pentyl-[1,1'-bi(cyclohexane)]-4-one
- EC Number:
- 617-638-6
- Cas Number:
- 84868-02-0
- Molecular formula:
- C17H30O
- IUPAC Name:
- (1's,4'r)-4'-pentyl-[1,1'-bi(cyclohexane)]-4-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Iva: NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 17 - 19 weeks
- Mean weight at study initiation: 3.40 (3.25 - 3.49) kg
- Housing: cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet: Altromin Standard Diet TPFV 2113, pellets from an automatic drinking device ad libitum
- Water: acidified, fully demineralized water from an automatic drinking device ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 43 - 64
- Photoperiod (hrs dark / hrs light): daylight
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g test item
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 animals - 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not performed
SCORING SYSTEM: OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.55
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- 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
- 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
- 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:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Ocular alterations:
After single instillation of 0.1 g test item into the conjunctival sac of the left eye, without rinsing, no irritation of the cornea and iris was observed. Examination of the conjunctivae revealed redness (score 1), chemosis in 1 animal (score 1), and discharge (score 1 - 2) at the first reading. Later on no irritation was seen. According to these results the test material is not regarded as an irritant. - Other effects:
- Signs of systemic toxicity, body weight, mortality:
No signs of systemic toxicity were seen. The body weight development corresponded to that of untreated rabbits of the same age. All animals survived the 8 day observation period.
Any other information on results incl. tables
Eye irritation results
|
|
Animal No. |
Sex |
Local findings (study day) |
|||||||
|
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
||
I Cornea |
A |
91003 |
m |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
91003 |
m |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
II Iris |
A |
91003 |
m |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
III Conjunctivae |
A |
91003 |
m |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
91003 |
m |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Discharge |
|
91003 |
m |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
91015 |
f |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
91021 |
f |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea A: rating according to OECD 405, B: rating according to Draize method, Iris A: rating according to OECD 405, Conjunctivae A: redness rating according to OECD 405, B: chemosis rating according to OECD 405
Body weight development
Body weight development in kg |
||||||
Administration |
Animal No. |
Sex |
Study day |
Difference |
||
1 |
5 |
8 |
||||
Eye |
91003 |
m |
3.45 |
3.51 |
3.49 |
+0.04 |
91015 |
f |
3.25 |
3.27 |
3.32 |
+0.07 |
|
91021 |
f |
3.49 |
3.58 |
3.61 |
+0.12 |
|
Mean values |
|
|
3.40 |
3.45 |
3.47 |
+0.07 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the primary eye irritation test no irritation of the cornea and iris was observed. The test item is not considered to be irritative.
- Executive summary:
The primary irritation potential of the test item was investigated by instillation of 0.1 g into conjunctival sac of the left eye of each of three young adult New Zealand White rabbits in an OECD 405 study. The right eye remained untreated and served as control. After instillation the eyelids were closed for about 30 seconds. Rinsing of the eyes was not performed. Scoring of irritation effects was performed daily after application for 8 days. After single instillation of 0.1 g test item into the conjunctival sac of the left eye, without rinsing, no irritation of the cornea and iris was observed. Examination of the conjunctivae revealed redness (score 1), chemosis in 1 animal (score 1), and discharge (score 1 - 2) at the first reading. Later on no irritation was seen. According to these results the test material is not regarded as an irritant. No signs of systemic toxicity were seen. The body weight development corresponded to that of untreated rabbits of the same age. All animals survived the 8 day observation period. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. Based upon the above results, the test item is considered to not be severely irritating to the eye.
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