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EC number: - | CAS number: -
- 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 July 26, 2012 to August 21, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to the OECD 404 and EU B4 Method with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000) including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Condensation products of cyclopentanone and pentaldehyde, fractionation pitch
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Condensation products of cyclopentanone and pentaldehyde, fractionation pitch
- Details on test material:
- - Name of test material (as cited in study report): Condensation products of cyclopentanone and pentaldehyde, fractionation pitch
- Physical state: Red-brownish liquid
- Analytical purity: UVCB.
- Expiration date of the lot/batch: 11 May 2013.
- Radiochemical purity (if radiolabelling):
- Stability under storage conditions: Stable.
- Storage condition of test material: At room temperature in the dark.
- Other:
Density: 0.95 g/cm3 (25°C).
pH: 8-10 at concentration of 5%.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany.
- Age at study initiation: at least 6 weeks old.
- Weight at study initiation: at least 1.0 kg.
- Housing: Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study period.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC.
- Humidity (%): 40-70%.
- Air changes (per hr): approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.
IN-LIFE DATES: From: July 26, 2012 To: August 02, 2012.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls.
- 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 the removal of the dressings and test substance.
- Number of animals:
- 3 Males.
- Details on study design:
- TEST SITE
- Area of exposure: 2x3 cm.
- Type of wrap if used: Micropore tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin cleaned of residual test substance using tap water and watery ethanol (50% v/v) (water: Elix, Millipore S.A.S., Molsheim, France; ethanol: Merck, Darmstadt, Germany).
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and eschar formation:
No erythema.........................................................0
Very slight erythema (barely perceptible).......1
Well-defined erythema.......................................2
Moderate to severe erythema...........................3
Severe erythema (beet redness) *....................4
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.
Oedema formation:
No oedema............................................................................................................................................................0
Very slight oedema (barely perceptible)..........................................................................................................1
Slight oedema (edges of area well-defined by definite raising)...................................................................2
Moderate oedema (raised approximately 1 millimeter).................................................................................3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)..............4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Irritation:
Four hours exposure to 0.5 mL of Condensation products of cyclopentanone and pentaldehyde, fractionation pitch resulted in very slight erythema and/or very slight oedema in the treated skin areas of the three rabbits. The skin irritation resolved within 24 hours after exposure in all animals.
Corrosion:
There was no evidence of a corrosive effect on the skin. - Other effects:
- Coloration / Remnants:
Brown staining of the treated skin by the test substance was observed on Day 1, which did not hamper the scoring of the skin reactions.
Toxicity / Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table1: Individual skin irritation scores.
Following exposure, Brown staining of the treated skin area was noted after removal of the test substance.
Animal |
|
3001 |
|
299 |
|
301 |
||||||
|
|
|
||||||||||
Time after exposure |
|
Erythema (0-4) |
Oedema (0-4) |
comments |
|
Erythema (0-4) |
Oedema (0-4) |
comments |
|
Erythema (0-4) |
Oedema (0-4) |
comments |
|
|
|
||||||||||
1 hour |
|
1 |
0 |
a |
|
1 |
1 |
a |
|
1 |
1 |
a |
24 hours |
|
0 |
0 |
- |
|
0 |
0 |
- |
|
0 |
0 |
- |
48 hours |
|
0 |
0 |
- |
|
0 |
0 |
- |
|
0 |
0 |
- |
72 hours |
|
0 |
0 |
- |
|
0 |
0 |
- |
|
0 |
0 |
- |
1Sentinel.
Comments:
a. Brown staining of the skin by the test substance.
Table2: Mean value irritation scores.
Animal |
|
Mean 24, 48 and 72 hrs |
||
|
|
Erythema |
|
Oedema |
300 |
|
0.0 |
|
0.0 |
299 |
|
0.0 |
|
0.0 |
301 |
|
0.0 |
|
0.0 |
Table3: Animal specifications.
Animal |
|
Sex |
|
Age at start |
|
Body weights (grams) |
|
(weeks) |
|
prior to application |
at termination |
||||
300 |
|
♂ |
|
10-12 |
|
2451 |
2521 |
299 |
|
♂ |
|
11-13 |
|
2329 |
2406 |
301 |
|
♂ |
|
11-13 |
|
2239 |
2360 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance does not have to be classified.
- Executive summary:
The primary skin irritation/corrosion of the substance was determinated according to OECD 404 guideline with GLP. Slight irritation was observed in all three animals (both score: oedema and erythema) in the treated skin areas after four hours with the score 1, this result was fully reversible within 24 hours after exposure in all animals.
There was no evidence of a corrosive effect on the skin.
Brown staining of the treated skin by the test substance was observed on Day 1, which did not hamper the scoring of the skin reactions.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Based on these results Condensation products of cyclopentanone and pentaldehyde, fractionation pitch does not have to be classified and has no obligatory labelling requirement for skin irritation according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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.
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