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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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From November 14 to December 16, 1977
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:
- 1 978
- Report date:
- 1978
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated insult patch test or Draize-Shelanski test
- GLP compliance:
- no
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:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Samples of 0977/1 10% in White Petrolatum
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 52 subjects; 50 subjects completed the study
- Sex: 25 males; 27 females
- Age: Males: 23-43 years (Caucasian); females: 20-49 years (Caucasian); 24-34 years (Negro) - Clinical history:
- None
- Controls:
- White Petrolatum
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: Patch test (epicutaneous test)
ADMINISTRATION
- Type of application: Occlusive
- Site of application: Upper back, scapular area for induction. Challenge patch was placed adjacent to but not in contact with the site of the induction applications.
- Description of patch: Readi-Band clear plastic patches, which are approximately 1 ½” square and contain a ¾” square nonwoven Webril centre were utilized for all patch applications.
- Vehicle / solvent: White petrolatum
- Concentrations: 0977/1 10% in White Petrolatum
- Volume applied: Approximately 0.2 mL
- Testing schedule:
Phase I (Induction phase): Total of 9 induction applications within a period of 3 consecutive weeks.
Phase II: During this phase, exposure to the test material was terminated for a period of 12 days following the last induction application (Thursday, Week 3)
Phase III (challenge phase): On the twelfth day following the last induction application, all panellists were exposed to a single, occluded patch application of the test material as in Phase I.
- Exposure period: 23 h
- Scoring schedule: Induction: skin sites were graded for irritation approximately 30-60 minutes following patch removal; challenge: Approximately 30-60 minutes following removal of the challenge patch, both the challenge site and site of the induction applications were graded for irritation. Both these sites were again observed for possible delayed reactions (indicative of sensitization) 48 and 72 hours after application of the challenge patch.
- Removal of patch: 23 h after application
EXAMINATIONS
Grading/Scoring system: Scoring Criteria for Skin Irritation Reactions
- Erythema and Eschar Formation:
No reaction: 0
Very slight erythema (barely perceptible): 1
Mild, well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
- Oedema Formation:
No reaction: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edge of area well-defined by definite raising): 2
Moderate oedema (area raised approximately 1 mm): 3
Severe oedema (area raised more than 1 mm and extending beyond area of exposure): 4
- Statistical analysis: None
Results and discussion
- Results of examinations:
- SYMPTOMS
- 0977/1 10% in White Petrolatum: Two subjects exhibited slight irritation reactions at random intervals during the course of the induction applications. These reactions were transient in nature and may be considered of little or no consequence based on the total response of the panel to the test product.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
0977/1 10% in White Petrolatum:
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 2
Any other information on results incl. tables
Table 7.10.4/1: Skin reactions
Test material |
No. of Reactors |
No. of Reactions |
No. of patches applied |
Reactions with scores |
||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
||||
0977/1 10% in White Petrolatum |
2 |
2 |
457 |
455 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-2-slight; 3-4=mild; 5-6=moderate; 7-8=severe
See the attached document for information on tables of results
Applicant's summary and conclusion
- Conclusions:
- Under the condition of the study, the test material is not a skin sensitizer at 10% in White Petrolatum.
- Executive summary:
A panel of 52 male and female human volunteers (50 subjects completed the study) participated in a repeat insult patch test in which a 10% in White Petrolatum of the test material was applied to the upper back, scapular area of the subjects under occlusive patches. During the induction phase nine patches were applied within a period of 3 consecutive weeks. The patches were removed 23 hours after application. On the twelfth day following the last induction application, a challenge patch was applied and the sites scored 24 h (30-60 minutes after removal of patch), 48 and 72 h after application.
At 10% in White Petrolatum, two subjects exhibited slight irritation reactions at random intervals during the course of the induction applications. These reactions were transient in nature and may be considered of little or no consequence based on the total response of the panel to the test product. There was no evidence of sensitization to either material noted at any time in any of the subjects participating in the study.
Under the conditions employed in this study, there was no evidence of sensitisation to the test material.
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