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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 265-779-3 | CAS number: 65443-14-3
- 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 03 to 12, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline No. 404 without any deviations.
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:
- 2 001
- Report date:
- 2001
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)
- Remarks:
- inspected on September 22, 1999/signed on January 18, 2000
Test material
- Reference substance name:
- 2,2,5-trimethyl-5-pentylcyclopentan-1-one
- EC Number:
- 265-779-3
- EC Name:
- 2,2,5-trimethyl-5-pentylcyclopentan-1-one
- Cas Number:
- 65443-14-3
- Molecular formula:
- C13H24O
- IUPAC Name:
- 2,2,5-trimethyl-5-pentylcyclopentan-1-one
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ST 13 C 01
- Physical state: Colourless liquid
- Storage condition of test material: Stored at room temperature.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France.
- Weight at study initiation: Mean body weight: 2.8 ± 0.1 kg
- Housing: Animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet: 110 pelleted diet (UAR, Villemoisson, Epinay sur-Orge, France), ad libitum
- Water: Drinking water (filtered by a FG Millipore membrane (0.22 µm)), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 h dark/ 12 h light
IN-LIFE DATES: From: July 03, 2001 To: July 12, 2001
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h after patch-removal. Since there was a persistent irritation reaction at 72 h, the observation period was extended up to their complete reversibility (Day 10).
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Right flank
- Type of wrap if used: Test substance was placed on the gauze pad and held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No; no residual test substance was observed on removal of the dressing.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scale, as described in OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- - A well-defined erythema (grade 2), in addition to a slight oedema (grade 2), was observed on Day 1 in all the animals.
- A well-defined erythema (grade 2) persisted in 1/3 animals from Day 2-6; a very slight erythema (grade 1) was then noted until Day 9. A very slight oedema (grade 1) was also observed on Day 2. In both remaining animals, a very slight erythema (grade 1) was recorded from Day 2-6.
- A dryness of the skin was observed in all the animals from Day 4 (two animals) or 7 to Day 9. Crusts were also noted in 1/3 animals on Days 5 and 6. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Mean skin irritant/corrosive response data for each animal at each observation time up to removal of animals from the test
Score at time point |
Erythema (Animal No. 1 / 2 / 3) Max. score 4 |
Oedema (Animal No. 1 / 2 / 3) Max. score 4 |
Other (Animal No. 1 / 2 / 3) |
1 h |
2/2/2 |
2/2/2 |
*/*/* |
24 h |
2/1/1 |
1/0/0 |
*/*/* |
48 h |
2/1/1 |
0/0/0 |
*/*/* |
72 h |
2/1/1 |
0/0/0 |
*/S/S |
Day 5 |
2/1/1 |
0/0/0 |
*/SA/S |
Day 6 |
2/1/1 |
0/0/0 |
*/SA/S |
Day 7 |
1/0/0 |
0/0/0 |
S/S/S |
Day 8 |
1/0/0 |
0/0/0 |
S/S/S |
Day 9 |
1/0/0 |
0/0/0 |
S/S/S |
Day 10 |
0/0/0 |
0/0/0 |
*/*/* |
Average 24, 48 and 72 h |
2/1/1 |
0.3/0/0 |
- |
Reversibility |
Completely reversible |
Completely reversible |
- |
Average time for reversion |
10 days |
48 h |
- |
Keys: * None; S= Dryness of the skin; A= Crust
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, test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of the undiluted test material was applied on the clipped skin of the right flank area of three male New Zealand White rabbits. The test material was held in contact with the skin by means of a semi-occlusive dressing for 4 h. The untreated skin served as control. Cutaneous reactions were assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after removal of the dressing and then daily until reversibility of cutaneous reactions (Day 10).
A well-defined erythema, in addition to a slight oedema, was observed on Day 1 in all the animals. A well-defined erythema persisted in 1/3 animals from Day 2-6; a very slight erythema was then noted until Day 9. A very slight oedema was also observed on Day 2. In both remaining animals, a very slight erythema was recorded from Day 2-6. A dryness of the skin was observed in all the animals from Day 4 (two animals) or 7, to Day 9. Crusts were also noted in 1/3 animals on Days 5 and 6.
The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 2.0 / 1.0 / 1.0 for erythema and 0.3 / 0.0 / 0.0 for oedema.
Under the test conditions, test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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.