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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD 1981
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Iva: NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 17 - 19 weeks
- Mean weight at study initiation: 3.33 (3.25 - 3.40) 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
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- the test material was moistened with aqua pro injectione
- Controls:
- no
- Amount / concentration applied:
- 0.5 g test item
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 animals - 1 male and 2 female
- Details on study design:
- TEST SITE
- Area of exposure: back side
- Type of wrap: polyethylene foil kept in place by a leather sleeve
REMOVAL OF TEST SUBSTANCE
- Washing: wiped off
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 hour after removal of the patches and afterwards daily for 14 days
SCORING SYSTEM: Draize and OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.97
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- Skin alterations:
Single application of 0.5 g test item to the intact dorsal skin of rabbits, after a 4 hour period of exposure under occlusive conditions, led to severe skin irritation. Erythema (score 1 or 2) from day 1 until day 6 of the study was seen. Edema (score 1 - 3) was observed from day 1 up to day 8 of the study. Erythema and edema were followed by necrosis, large scales (as indicated by score 4), and small scales, which are indicative of corrosivity of the test material.
The cumulative mean scores for erythema and edema were:
Day 1 : 1.9
Day 2 : 2.2
Day 3 : 1.8
Though the cumulative scores for erythema and edema for days 1, 2, and 3 were not indicative of serious effects attention must be given to the corrosive effects. - Other effects:
- Signs of systemic toxicity, body weight, mortality:
No signs of systemic toxicity were detected. The body weight development corresponded to that of untreated rabbits of the same age. All rabbits survived the 15 day observation period.
Any other information on results incl. tables
Skin irritation results
Animal No. |
Sex |
back site |
|
Local findings (study day) |
||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
12 |
14 |
15 |
||||
91012 |
male |
left |
Erythema |
2 |
2 |
2 |
2 |
2 |
4 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
Edema |
2 |
3 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
G |
G |
0 |
S |
S |
S |
S |
S |
|||
right |
Erythema |
2 |
2 |
2 |
2 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
||
Edema |
2 |
3 |
3 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
G |
G |
G |
G |
G |
G |
S |
S |
|||
91023 |
female |
left |
Erythema |
2 |
2 |
1 |
1 |
1 |
1 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
Edema |
2 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
|
G |
G |
S |
S |
S |
S |
S |
|||
right |
Erythema |
2 |
2 |
1 |
1 |
1 |
1 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
||
Edema |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
|
G |
0 |
S |
S |
S |
S |
S |
|||
91015 |
female |
left |
Erythema |
2 |
2 |
2 |
2 |
2 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
Edema |
2 |
3 |
2 |
2 |
2 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
|
N |
N |
N |
N |
N |
GS |
0G |
|||
right |
Erythema |
2 |
2 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
||
Edema |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
N |
N |
N |
N |
N |
N |
N |
N |
NGS |
GS |
|||
Mean values |
Erythema |
2.0 |
2.0 |
1.7 |
|
|
|
|
|
|
|
|
|
|
||
Edema |
1.8 |
2.3 |
1.8 |
|
|
|
|
|
|
|
|
|
|
|||
Cumulative mean values |
|
1.9 |
2.2 |
1.8 |
|
|
|
|
|
|
|
|
|
|
Body weight development
Body weight development in kg |
|||||||||
Administration |
Animal No. |
Sex |
Study day |
Difference |
|||||
1 |
5 |
8 |
11 |
15 |
|||||
Skin |
91012 |
m |
3.40 |
3.45 |
3.55 |
3.55 |
3.66 |
+0.26 |
|
91023 |
f |
3.34 |
3.34 |
3.38 |
3.42 |
3.46 |
+0.12 |
||
91015 |
f |
3.25 |
3.23 |
3.24 |
3.24 |
3.23 |
-0.02 |
||
Mean values |
|
|
3.33 |
3.34 |
3.39 |
3.40 |
3.45 |
+0.12 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test material produced corrosive effects on contaminated skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated by topical application of 0.5 g to skin of the back and sides of each of three young adult New Zealand White rabbits in a OECD 404 study. The duration of treatment was four hours. The scoring of skin reactions was performed 1 hour after removal of the dressing and afterwards daily for 14 days. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. In the primary skin irritation test slight and well-defined erythema (score 1 or 2) and edema were observed on the first days after application, and were followed by necrosis, large scales, and small scales later on, indicating corrosivity of the test material. Though the cumulative mean scores for erythema and edema for days 1, 2, and 3 were not indicative of serious effects, the test material produced corrosive effects on skin contaminated under conditions comparable to those of this test.
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