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EC number: 255-673-5 | CAS number: 42131-27-1
- 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:
- Experimental start date 15 April 1997. Experimental end date: 17 April 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
- Principles of method if other than guideline:
- The product was applied diluted at 10% in parafin oil just once on a surface area of about 50mm2 on the underside of the arm of cach volunteer. A dose of about 0.02ml was rubbed into a round paper filter and placed in the well of the patch.
Note: This dose was chosen because of the well's capacity as indicated by the manufacturer of "Finn Chambers".
The product was in contact with the skin for 48 consecutive hours,
At the same time, a parallel experiment was carried out with a patch-test only (none of the product was used) to serve as a negative control.
Readings
Macroscopic examinations of the skin took place immediately, 30 minutes after the patch had been removed. The assessment of skin reactions (crythema, oedema etc.) were classified under the nomenclature proposed by the linternational Contact Dermatitis Research Group (I.C.D.R.G.) - GLP compliance:
- yes
- Remarks:
- Good clinical practice
Test material
- Reference substance name:
- Isotridecyl isononanoate
- EC Number:
- 255-673-5
- EC Name:
- Isotridecyl isononanoate
- Cas Number:
- 42131-27-1
- Molecular formula:
- C22H44O2
- IUPAC Name:
- Isotridecyl isononanoate
Constituent 1
Test animals
- Species:
- other: Human
- Details on test animals or test system and environmental conditions:
- Volunteers
Characteristics of subjects
- 20 subjects were included in the experiment
- 0 were female and 20 of were male - between 19 and 48 years old.
All of the subjects must meet the inclusion criteria and did not reflect any of the cxclusion crileria.
Inclusion criteria
- no previous intolerance or allergy to a cosmetic product
- a signed written consent form
Exclusion criteria
- skin disease, regardless of location
- undergoing treatment which interscres with skin metabolism, especially isotrellinoine, tretinoine, acitretine and etretinate.
Test system
- Type of coverage:
- occlusive
- Vehicle:
- other: Parafin oil
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- The product was applied diluted at 10% in parafin oil.
A dose of about 0.02ml was rubbed into a round paper filter and placed in the well of the patch. - Duration of treatment / exposure:
- 48 hours
- Observation period:
- 48.5 hours
in the absence of any topical skin reaction after 30min, and once the dressing had been removed, the experiment is stopped. However, each volunteer must verify the lack of reaction the following day. If there is a visible reaction, the volunteer must return to the centre. In the case of any sort of clear, or dubious reaction, a reading is taken after 24 hour's and, if necessary, 72 hours after the dressing has been removed, - Number of animals:
- 20
- Details on study design:
- Readings
Macroscopic examinations of the skin took place immediately, 30 minutes after the patch had been
removed.
The assessment of skin reactions (crythema, oedema etc.) were classified under the nomenclature proposed by the linternational Contact Dermatitis Research Group (I.C.D.R.G.)
NT: Not tested
?+: Dubious reaction. Only slight erythema
+: Positive weak reaction (non vesicular): crythema, infiltration, sometimes a few papules
++: Strong positive reaction: erythema, papules or vesicles
+++: Violent positive reaction, with cysts
-: Negative reaction
IR: Irritation reaction
E 0.5: very slight erythema
E1: slight erythema
E2: moderate erythema
E3: significant erythema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Observation
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Results table
Subject | Product Under study: PA.276/97 |
Negative control | |||
Identification | Age & Sex | reading 30min after patch removal |
reading 2411 after patch removal |
reading 30min after patch removal |
reading 2411 after patch removal |
BE.FR | 23 M | - | - | - | - |
MA.CE | 21 M | - | - | - | - |
TR.CL | 33 M | - | - | - | - |
HO.FM | 35 M | - | - | - | - |
RO.FR | 24 M | - | - | - | - |
GR.BR | 35 M | - | - | - | - |
HE.MI | 26 M | - | - | - | - |
CR.EH | 25 M | - | - | - | - |
PR.MA | 35 M | - | - | - | - |
LA.BE | 30 M | - | - | - | - |
SA.NI | 23 M | - | - | - | - |
LA.PA | 27 M | - | - | - | - |
CE.ER | 19 M | - | - | - | - |
VA.FR | 36 M | - | - | - | - |
MA.CY | 23 M | - | - | - | - |
MO.LU | 33 M | - | - | - | - |
FE.RU | 25 M | - | - | - | - |
PU.PH | 36 M | - | - | - | - |
AT.PH | 30 M | - | - | - | - |
BO.FR | 48 M | - | - | - | - |
AII* | 0 | 0 | 0 | 0 |
Results** | non irritant | non irritant | non irritant | non irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these cxpcimental conditions, no volunteers had a significant topical skin intolerance reaction at any stage during the experiment. In addition, no secondary effects were observed.
It can thus be concluded that the product, applical diluted at 10% in parasin oil topically under an occlusive dressing for 48 hours, on the skin of 20 adult volunteers was shown to be non irritant. - Executive summary:
A study was carried out of the acute skin tolerance of 20 adult volunteers using a 48 hour patch test.
The objective was to determine the primary irritant potential of a cosmetic product on a volunteer after a single application for a 48 hours period. The product was applied diluted at 10% in parafin oil.
The experiment was an open study performed on 20 subjects whose skin was free of dermatological lesions and were non allergic.
Assessment was determined on average irritation score, and the classifcation of product is based on its I.I. M.
In conclusion the average irritation of the product is equal to 0. It is thus non irritant.
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