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EC number: 701-234-2 | CAS number: 18402-84-1
- 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
- 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:
- 2009-04-16 to 2009-07-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (3E)-dec-3-en-2-one
- Cas Number:
- 18402-84-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- (3E)-dec-3-en-2-one
- Details on test material:
- - CAS: 18402-84-1
- Purity: 98.57% to 99.11% w/w
- Batch No.: Lot KB 147-36-1
- Physical state: liquid
- Colour: Colorless to pale yellow
- Storage conditions: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Robinson Services, Inc. Clemmons, NC on April 22, 2009
- Age at study initiation: Young adult
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Pelleted Purina Rabbit Chow #5326
- Water: Filtered tap water was supplied ad-libitum by an automatic water dispensing system
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 40-66
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The animals were observed and scored for skin irritation according to Draize at 30-60 minutes, 24, 48 and 72 hours and at 7, 10 and 14 days after patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: semi-occlusive
- Type of wrap if used: Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing: yes, ffter 4 hours of exposure to the test substance, the pads and the collars were removed and the test sites were gently cleansed of any residual test substance.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
30-60 minutes, 24, 48 and 72 hours and 7, 10 and 14 days after patch removal.
SCORING SYSTEM:
- Method of calculation: According to Draize [J. Pharmacol. Exp. Ther. 1944, 82: 377-390]. The classification of irritancy was obtained by adding the average erythema and edema scores for the 30-60 minutes, 24, 48, and 72-hour scoring intervals and dividing by the number of evaluation intervals. The resulting Primary Dermal Irritation Index (PDII) was classified as follows:
PDII: 0 = non irritating
PDII >0 - 2.0 = slightly irritating
PDII 2.1 - 5.0 = Moderately irritating
PDII > 5.0 Severly irritating
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- Apart from one male exhibiting small feces on Day I, the animals appeared active and healthy during the study. One hour after patch removal, all three treated sites exhibited well-defined to severe erythema and moderate edema. At 48 hours through 72 hours, irritation increased to severe erythema for one animal. The overall incidence and severity of irritation decreased gradually thereafter. Although hyperkeratosis and desquamation were noted for all three animals between Days 7 and 14, they were free of erythema and edema by Day 14 (study termination). The Primary Dermal Irritation Index for the test substance is 5.5.
For detailed results please refer to table 1 and table 2 in box "Any other information on results incl. tables".
Any other information on results incl. tables
Table 1: Individual skin irritation score
Animal No |
Sex |
Time after patch removal |
||||||
30 -60 min |
24 hrs |
48 hrs |
72 hrs |
Day 7 |
Day 10 |
Day 14 |
||
3501 |
M |
2/3 |
2/2 |
3/2 |
3/2 |
2/1a |
1/0a,b |
0/0b,c |
3502 |
M |
3/3 |
3/3 |
3/2d |
3/2d |
2/1a |
0/0a,b |
0/0b,c |
3503 |
M |
4/3e |
4/2e |
4/2f |
4/2f |
3/1a,d |
1/0a,b |
0/0b,c |
a Hyperkeratosis
b New skin
c Desquamation
d Small dark red areas in dose site.
e Dark red areas in dose site.
f Small black areas in dose site.
Table 2 : Summary of primary skin irritation scores*
|
Time after patch removal |
||||||
|
30 -60 min |
24 hrs |
48 hrs |
72 hrs |
Day 7 |
Day 10 |
Day 14 |
Erythema |
3.0 |
3.0 |
3.3 |
3.3 |
2.3 |
0.7 |
0 |
Edema |
3.0 |
2.3 |
2.0 |
2.0 |
1.0 |
0 |
0 |
TOTAL (PDI)** |
6.0 |
5.3 |
5.3 |
5.3 |
3.3 |
0.7 |
0 |
* Average values for three rabbits.
** PDI = Average Erythema + Average Edema
Primary Dennal Irritation Index (PDII): (PDI for 30-60 minutes, 24,48 and 72 hours) /4 = 5.5
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In conclusion, the test item is severly irritating to the skin of rabbits when applied for 4 h under semi-occlusive conditions.
- Executive summary:
In a primary dermal irritation study conducted according to OECD 404 three albino New Zealand White rabbits were dermally exposed to 0.5 mL the test item for 4 hours under semi-occlusive conditions. Animals then were observed for 14 days. Irritation was scored by the method of Draize. In this study, the test item is severely irritation to the skin based on the observation made. One hour after patch removal, all three treated sites exhibited well-defined to severe erythema and moderate edema. At 48 hours through 72 hours, irritation increased to severe erythema for one animal. The overall incidence and severity of irritation decreased gradually thereafter. Although hyperkeratosis and desquamation were noted for all three animals between Days 7 and 14, they were free of erythema and edema by Day 14. Based on these findings, the test item is considered to be irritant to the skin and in accordance with CLP Regulation 1272/2008 classification as Skin Irrit. 2 (H315) is warranted.
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