Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: not irritating (OECD 404, GLP, K, rel. 1).
Eye irritation: not irritating (Read-across: OECD 405 / EU B.5, GLP, WoE, rel. 2).
Respiratory irritation: this information is not available.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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)
- 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 - 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) - 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
- 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.
Reference
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 |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
In the dermal irritation study of Aarup, performed according to the OECD guideline No. 404, and in compliance with GLP, 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.
In the dermal irritation study of Leuschner, conducted on the supporting substance (EC 422 -320 -3), and also performed according to the OECD guideline No. 404, and in compliance with GLP, similar results were drawn. The mean scores calculated for each animal tested within 3 scoring times (24, 48 and 72 h) were 1.0 / 1.3 / 1.0 for erythema and 1.0 / 1.0 /1.0 for oedema. Induration of the skin was observed in all animals 5 and 6 days after patch removal. Laceration of the skin was observed in one animal 5 and 6 days after patch removal. Peeling of the skin was observed in one animal 6 days, in another animal 5 and 6 days after patch removal. All the skin lesions were fully reversible at the end of the observation period (Day 7). This study is used for comparative purpose only (read across-justification), as a key study is available on the substance itself.
Eye irritation:
No studies were located on Pentadecan-15 -olide, therefore, a weight of evidence approach using the two studies conducted on the supporting substance (EC 422 -320 -3) was used to conclude on this endpoint. This read-across is justified is Iuclid section 13. In the two eye irritation studies performed according to the OECD test guideline No. 405 / E.U. method B.5, and in compliance with GLP, the test material was not irritating to the eye of rabbits. In the study of Chubb, the calculated mean score for each individual lesion for all 4 animals within 3 scoring times (24, 48 and 72 h) were 0.00 for chemosis, redness, discharge, iris and corneal lesions. In the study of Leuschner, the calculated mean score for each individual lesion for each animal within 3 scoring times (24, 48 and 72 h) were 0.00 / 0.33 /0.00 for redness, and 0.00 / 0.00 /0.00 for chemosis, discharge, iris and corneal lesions.
Justification for selection of skin irritation / corrosion endpoint:
One study available on the substance itself (Aarup, 1994), GLP-compliant and of high quality (Klimisch score = 1). The same conclusion was drawn with the supporting substance (EC 422-320-3) (Leuschner, 2004).
Justification for selection of eye irritation endpoint:
No study was available on the substance itself, therefore, a weight of evidence approach using two reliable studies conducted on the supporting substance (EC 422-320-3) (Leuschner, 2004 & Chubb, 1992) was selected as the best strategy to conclude on toxicological properties.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP3.
Self-classification:
Based on the available information no additional self-classification is proposed regarding both skin and eye irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.