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EC number: 851-742-4 | CAS number: 464207-51-0
- 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:
- From 1991-07-09 to 1991-07-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 404 and in compliance with GLP with minor deviations (age of animals at study initiation not reported). Except for this minor deviation, the study was fully reliable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age of animals at study initiation not reported
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age of animals at study initiation not reported
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP (inspection date: 1990-06-19 / signature date: 1990-10-05)
Test material
- Reference substance name:
- (5E)-3-Methyl-5-cyclopentadecen-1-one
- Cas Number:
- 101151-17-1
- Molecular formula:
- C16 H28 O
- IUPAC Name:
- (5E)-3-Methyl-5-cyclopentadecen-1-one
- Reference substance name:
- (5Z)-3-Methyl-5-cyclopentadecen-1-one
- Cas Number:
- 21944-94-5
- Molecular formula:
- C16 H28 O
- IUPAC Name:
- (5Z)-3-Methyl-5-cyclopentadecen-1-one
- Reference substance name:
- (4E)-3-Methyl-4-cyclopentadecen-1-one
- Cas Number:
- 62221-84-5
- Molecular formula:
- C16 H28 O
- IUPAC Name:
- (4E)-3-Methyl-4-cyclopentadecen-1-one
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless liquid
- Reception date: 1991-06-27
- Storage condition of test material: in the dark at about 4°C
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- - Lot/batch No.: A/S/31635 (lab code)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex.
- Age at study initiation: no data
- Weight at study initiation: 2.6-3.0 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC standard rabbits pellets, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C. On 3 occasions the temperature exceeded this range by 1°C.
- Humidity (%): 59-69 % with the exception of one occasion when a value of 76 % relative humidity was recorded.
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after patch removal. Additional examination on day 7.
- Number of animals:
- 4 animals
- Details on study design:
- TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 2.5 cm square (6.25 cm2)
- Type of wrap if used: surgical lint held in position with "Elastoplast" elastic adhesive bandage 7.5 cm wide.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale according to OECD guideline No. 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- One hour after the end of the dosing period, erythema varying in degree from slight to well defined was apparent in all 4 rabbits and very slight oedema was noted in 2 of the 4 animals.
24 hours after patch removal erythema and oedema were observed in all 4 rabbits.
At the 72 hour assessment, irritation has entirely subsided in 2 animals. Erythema was slight to moderate in the remaining 2 rabbits.
7 days after the dosing, erythema and oedema were no longer apparent in any of the animal although skin thickening was noted in one of them. - Other effects:
- none
Any other information on results incl. tables
Table 7.3.1/1: Irritant/corrosive response data at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
2/2/2/1 |
1/0/1/0 |
24 h |
1/1/1/2 |
2/1/1/1 |
48 h |
2/1/0/3 |
1/1/0/1 |
72 h |
3/0/0/3 |
1/0/0/2 |
Average 24h, 48h, 72h |
2/0.7/0.3/2.7 |
1.3/0.7/0.3/1.3 |
Reversibility*) |
c |
c |
Average time (day) for reversion** |
7 days |
7 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
**): correspond to the last day for which skin irritation signs in the last animal were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material induced a slight irritation being largely reversible within 7 days of dosing.
Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) as scores were below 2.3 and to the GHS as only 2 animals out of 4 had scores between 1.5 and 2.3. - Executive summary:
In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test material was dermally applied on the shaved skin of the dorsal surface of the trunk of 4 New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 7 days for oedema and erythema.
Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch and on day 7.
The mean scores over all the animals tested within 3 scoring times (24, 48 and 72 hrs) were 2.0/0.7/0.3/2.7 for erythema and 1.3/0.7/0.3/1.3 for oedema.
Under the test conditions, the test material induced a slight irritation being largely reversible within 7 days of dosing.
Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) as scores were below 2.3 and to the GHS as only 2 animals out of 4 had scores between 1.5 and 2.3.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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