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Diss Factsheets
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EC number: 812-241-6 | 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Human Repeat Insult Patch Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 November 2015 - 9 January 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Human Repeat Insult Patch Test using generally-accepted methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Repeated Insult Patch Test was performed to confirm that repeated applications of the product under maximized conditions, in healthy subjetcs, does not induce delayed contact allergy reactions. A secondary objective is to determine the irritating potential of the product first after a single application and second after repeated applications.
- GLP compliance:
- no
- Remarks:
- study has been conducted in the spirit of the good Clinical Practice
- Type of study:
- patch test
- Justification for non-LLNA method:
- HRIPT study in human volunteers already available
Test material
- Reference substance name:
- Enzymatic hydrolysis products of Ophiopogon japonicus, Liliaceae, root
- EC Number:
- 812-241-6
- Cas Number:
- 952500-62-8
- IUPAC Name:
- Enzymatic hydrolysis products of Ophiopogon japonicus, Liliaceae, root
- Test material form:
- liquid
- Details on test material:
- transparent solution
pH 5.2
Constituent 1
In vitro test system
- Details on the study design:
- Not applicable
In chemico test system
- Details on the study design:
- Not applicable
In vivo test system
Test animals
- Species:
- other: Human
- Details on test animals and environmental conditions:
- - Number of subjects empanelled: 110
- Number of subjects completed the study: 106 (4 drop out)
- Age: 18-68 years
- The subjects choosen cooperative subjects, aware of tge necessity and duration of the controls so that perfect adhesion to the procol established by Dermscan could be expected.
Inclusion citeria were: subjects having given their informed, written consent and subjects without scars, tatoos, any pigmentary marks, ecessive pilosity and uneven skkin tone or active dermal lesions, on the concerned areas of the back.
Study design: in vivo (non-LLNA)
- Details on study design:
- Monocentric and simple blind study.
TYPE OF TEST(S) USED: patch test
ADMINISTRATION
- Type of application: occlusive
- Application area: The back: homolateral (Induction site) and contralateral (challenge site)
- Description of patch: Finn's chamber occlusive (8 mm) (50 mm²)
- Volume applied: 25 µL
The studied product was applied to a cleansed (with physiological saline or water) and dry skin.
- Application frequency:
Induction phase: 3 times a week during 48 hours (72 h for the week-end)
Challenge phase: once durig 48 hours
- Study schedule: cf Any other information on materials and methods Table 2
EXAMINATIONS
After each application, the patch is removed and the clinical examination is performed by the investigator 30 minutes later in order to eliminate the pressure and the occlusive effects. The resulf ot the examination id negative if the skin looks normal. The clinical examination is made on the back using the following criteria and scale:
Clinical criteria regarding the irritating potential (induction phase)
- Grading/Scoring system:
0 = No erythema, no edema
0.5 = very slight = erythema: bareky perceptible: pinkish coloration of one part of the tested area and palpable and barely visible edema
1 =Slight = eruthema: pinkish coloration of the complete tested area or rather visible on one part of the tested area, and palpable and visible edema
2 =Net = obvious erythema covering the whole tested arean and obvious edema (thickness <1mm) with or without blister or vesible
3 = important = severe erythema covering all the tested area or obvious erythema diffusion outside the tested area, and severe edema (thickness > 1mm of diffusiong outside the tested area) with our without vesicle or blister.
Clinical criteria regarding the sensitizing potential ( challenge phase) : cf. Any other information on materials and methods Table 1
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 25 µL of OF14 ATS
- No. with + reactions:
- 0
- Total no. in group:
- 106
- Clinical observations:
- During the induction or challenge phase, no skin reactions were observed. “OF14 ATS” showed a score of 0.01. No reaction ++ nor +++ was observed, so the product “OF14 ATS” can be considered as non-sensitizing
Any other information on results incl. tables
RESULTS INTERPRETATION:
At the end of the 9 readings of the induction phase, the average score of each subject (Cumulative irritation index CII) is calculated by adding the scores obtained for each readings and by dividing this sum by the actual number of readings.
The irritating potential of the product is estimated by calculating the mean of the reactions observed during the induction phase in order to obain the Mean cumulative Irritation Inde (MCII). the obtained index allows to arbitrarily classify the studied product according to the following scale:
|
Challenge phase:
A possible reaction during the induction or challenge phase is assessed from 0 to 3 according to ICDRG (International Contact Dermatitis Research Group) (see table 1) . During the Challenge phase, the reading is done 30 minutes after patch-tests removal and 48 hours later. The sensitizing potential of the product is assessed by the readings on D37 and D39 according to the following criteria reaction++ or +++ in the absence of added irritation phenomenon. The presence of only one case of active sensitization or controlateral side leads to the conclusion "Potentially sensitizing product".
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these study conditions, the product “OF14 ATS” can be considered non-irritating and non-sensitizing
- Executive summary:
A panel of 110 male and female human volunteers participated in a repeat insult patch test in which a test product OF14 ATS applied to the back of the subjects under occlusive patches. 106 subjects completed the study.
During the induction or challenge phase, no skin reactions were observed.“OF14 ATS” showed a score of 0.01. It can thus be considered as non-irritating.
No reaction ++ nor +++ was observed, so the product “OF14 ATS” can be considered as non-sensitizing
Under these study conditions, the product “OF14 ATS” can be considered non-irritating and non-sensitizing
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