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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 12, 2011 to July 26, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to the OECD 423 Guideline, 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines 2000 (Japanese Ministry of Agriculture, Forestry and Fisheries)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
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:
- - Physical state: Red-brownish liquid.
- Analytical purity: UVCB
- Expiration date of the lot/batch: 11 May 2013
- 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:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: From 170 to 203 g bw. Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- 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 December 14, 2011 to January 3, 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL.
- Amount of vehicle (if gavage): 8.39 g/kg.
- Justification for choice of vehicle: The vehicle was selected based on trial formulations and on test substance data supplied by the sponsor.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw.
DOSAGE PREPARATION: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle and density of the test substance. - Doses:
- 2000 mg/kg (10mL/kg) bw.
- No. of animals per sex per dose:
- 6 females separated in two groups of three.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days.
- Frequency of observations and weighing:
Mortality/viability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Hunched posture and/or piloerection were noted in all animals on Day 1. One animal showed hunched posture on Day 2.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Any other information on results incl. tables
Table 1. MORTALITY DATA
TEST DAY |
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
HOURS AFTER TREATMENT |
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FEMALES 2000 mg/kg |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
FEMALES 2000 mg/kg |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Table 2. CLINICAL SIGNS
TEST DAY |
|
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
HOURS AFTER TREATMENT |
Max Grade |
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FEMALES 2000 mg/kg |
|
|||||||||||||||||
ANIMAL 1 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur Piloerection |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 2 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur Piloerection |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 3 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur Piloerection |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
||||||||||||||||||
FEMALES 2000 mg/kg |
|
|||||||||||||||||
ANIMAL 4 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 5 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 6 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- = SIGN NOT OBSERVED / . = OBSERVATION NOT PERFORMED / + = ANIMAL DEAD
Table 3. BODY WEIGHTS (GRAM)
SEX/DOSE LEVEL |
ANIMAL |
DAY 1 |
DAY 8 |
DAY 15 |
FEMALES 2000 MG/KG |
1 |
173 |
192 |
198 |
2 |
188 |
206 |
220 |
|
3 |
170 |
188 |
199 |
|
MEAN |
177 |
195 |
206 |
|
ST. DEV. |
10 |
9 |
12 |
|
N |
3 |
3 |
3 |
|
FEMALES 2000 MG/KG |
4 |
193 |
226 |
228 |
5 |
189 |
212 |
217 |
|
6 |
203 |
227 |
237 |
|
MEAN |
195 |
222 |
227 |
|
ST. DEV. |
7 |
8 |
10 |
|
N |
3 |
3 |
3 |
Table 4. MACROSCOPIC FINDINGS
ANIMAL |
ORGAN |
FINDING |
DAY OF DEATH |
FEMALES 2000 mg/kg |
|||
1 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
2 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
3 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
FEMALES 2000 mg/kg |
|||
4 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
5 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
6 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of the test substance in Wistar rats was determined to be greater than 2000 mg/kg bw.
- Executive summary:
Assessment of acute oral toxicity with Condensation products of cyclopentanone and pentaldehyde, fractionation pitch in the rat (Acute Toxic Class Method) was determinated according to the OECD 423 Guideline, with GLP.
The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.
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 acute oral toxicity 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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