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EC number: 203-354-6 | CAS number: 106-02-5
- 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 1994-11-28 to 1994-12-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD test guideline No. 404 and in compliance with GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Pentadecan-15-olide
- EC Number:
- 203-354-6
- EC Name:
- Pentadecan-15-olide
- Cas Number:
- 106-02-5
- Molecular formula:
- C15H28O2
- IUPAC Name:
- 1-oxacyclohexadecan-2-one
- Test material form:
- other: solid gel
- Details on test material:
- - Physical state: Solid clear gel
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: stock Mol:Russian from Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.3 kg bw
- Housing: individually, in 62 x 52 cm PPO cages with perforated floor
- Diet (e.g. ad libitum): A pelleted complete rabbit diet "Altromin 2123" from Chr. Petersen, DK-4100 Ringsted, was available ad libitum. Analyses for major nutritive components and significant contaminants are performed regularly on the diet. Certificates of analysis are retained.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for possible contaminants are performed regularly. Certificates of analysis are retained.
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%):55 +/- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: Ethanol 96% and diethyl phthalate (DEP) (1 : 1 (w/w))
- Controls:
- other: one of the 6 test site per animal was a vehicle control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of each test concentration
- Concentration (if solution): 100%, 20% (w/w), 10% (w/w), 5% (w/w), 1% (w/w).
VEHICLE
- Source of the lot/batch no.: Merck, Bie & Berntsen, Denmark - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days. Readings at 1, 24, 48 and 72 hours; then on Day 7 and 14.
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: an area of 10 x 10 cm on the back (2.5 x 2.5 cm per gauze patch). The clipped area was divided into 6 test sites: 2 anterior located test sites, 2 centrally located test sites and 2 posterior located test sites.
- Type of wrap if used: semi-occlusive dressing: a 1 cm wide adhesive tape and fixed with Scanpor tape, 4.5 cm width, loosely wound round the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with soap and lukewarm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale (according to OECD 404)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 4 animals
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 1.58
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Concentration = 100 %
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 4 animals
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0.08
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Concentration = 100 %
- Irritant / corrosive response data:
- In general slight to well defined erythema was observed 1 to 72 hours after termination of exposure of 100% and 20% concentration of test article. Similarly in general slight erythema was observed 1 to 72 hours alter termination of exposure of 10%, 5% and 1% concentration of test article. Slight oedema was only observed in 1 rabbit 48 hours after termination of exposure of 100% and 20% concentration of test article. Thereafter no oedema was observed.
On day 7 and 14 dose related accumulations of scales were observed in all rabbits. On day 14 the skin of all rabbits was intact. - Other effects:
- none
Any other information on results incl. tables
Table 7.3.1/1: Mean irritant/corrosive response data for the 4 animals at each observation time up to removal of animals from the test – Concentration = 100 %
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
1 |
0 |
24 h |
1.75 |
0 |
48 h |
1.5 |
0.25 |
72 h |
1.5 |
0 |
Average 24h, 48h, 72h |
1.58 |
0.08 |
Reversibility*) |
c. |
c. |
Average time (day) for reversion |
14 d |
3 d |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Table 7.3.1/2: Mean irritant/corrosive response data for the 4 animals at each observation time up to removal of animals from the test – Concentration = 20 %
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
1 |
0 |
24 h |
1.5 |
0 |
48 h |
1.5 |
0.25 |
72 h |
1.5 |
0 |
Average 24h, 48h, 72h |
1.5 |
0.08 |
Reversibility*) |
c. |
c. |
Average time (day) for reversion |
14 d |
3 d |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Table 7.3.1/3: Mean irritant/corrosive response data for the 4 animals at each observation time up to removal of animals from the test – Concentration = 10 %
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
0.5 |
0 |
24 h |
1 |
0 |
48 h |
0.75 |
0 |
72 h |
1 |
0 |
Average 24h, 48h, 72h |
0.92 |
0.0 |
Reversibility*) |
c. |
- |
Average time (day) for reversion |
14 d |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Table 7.3.1/4: Mean irritant/corrosive response data for the 4 animals at each observation time up to removal of animals from the test – Concentration = 5 %
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
0.25 |
0 |
24 h |
0.5 |
0 |
48 h |
0.25 |
0 |
72 h |
0.5 |
0 |
Average 24h, 48h, 72h |
0.42 |
0.0 |
Reversibility*) |
c. |
- |
Average time (day) for reversion |
14 d |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Table 7.3.1/5: Mean irritant/corrosive response data for the 4 animals at each observation time up to removal of animals from the test – Concentration = 1 %
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
0.5 |
0 |
24 h |
0.75 |
0 |
48 h |
0.75 |
0 |
72 h |
0.5 |
0 |
Average 24h, 48h, 72h |
0.67 |
0.0 |
Reversibility*) |
c. |
- |
Average time (day) for reversion |
14 d |
- |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test material induced a slight irritation being reversible within 14 days of dosing.
Therefore the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC. - Executive summary:
In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of different concentration of test material (undiluted, 20, 10, 5, 1 % in EtOH/DEP 1:1) were dermally applied on the clipped 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 and then rinsed with soap and warm water. Animals were then observed for 14 days for oedema and erythema.
Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after the removal of the patch and on day 7 and 14.
The mean scores calculated over all the animals tested with the undiluted test material within 3 scoring times (24, 48 and 72 h) were 1.58 for erythema and 0.08 for oedema.
Slight to well defined erythema was observed 1 to 72 hours after termination of exposure of 100% and 20% concentration of test article. Similarly slight erythema was observed 1 to 72 hours alter termination of exposure of 10%, 5% and 1% concentration of test article. Slight oedema was only observed in 1 rabbit 48 hours after termination of exposure of 100% and 20% concentration of test article. Thereafter no oedema was observed.
On day 7 and 14 dose related accumulations of scales were observed in all rabbits. On day 14 the skin of all rabbits was intact.
Under the test conditions, the test material induced a slight irritation being reversible within 14 days of dosing.
Therefore the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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