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EC number: 296-251-0 | CAS number: 92456-72-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Manihot utilissima, Euphorbiaceae.
- 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:
- key study
- Study period:
- June - July 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Human Repeat Insult Patch Test using generally-accepted methods
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- Datas on human volunteers are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- A clinical study on human volunteers show that the substance has no skin sensitization potential. See end-point 7.10.4
- Reason / purpose for cross-reference:
- data waiving: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The method used is an adaptation from that described by Marzulli and Maibach (Human Repeated Insult Patch Test for delayed contact hypersensitivity: HRIPT) - Marzulli F.N., Maibach H.I., Contact allergy: predictive testing in man, Contact dermatitis, 1976, 2, pp.1-17
- GLP compliance:
- no
- Remarks:
- study has been conducted in the spirit of the good Clinical Practice
Test material
- Reference substance name:
- Cassava, ext.
- EC Number:
- 296-251-0
- EC Name:
- Cassava, ext.
- Cas Number:
- 92456-72-9
- IUPAC Name:
- Cassava, ext.
- Test material form:
- solid - liquid: aqueous solution
- Details on test material:
- Yellow liquid
Constituent 1
- Specific details on test material used for the study:
- Tested diluted at 15% in water
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- 108 volunteers were included in the study, 4 volunteers discontinued for personal reasons independent of the study and no exclusion was decided by the investigator.
- Controls:
- A control site (without test products) served as control to avoid the possible intercurrent eftects not directly related to the test raw material.
- Route of administration:
- dermal
- Details on study design:
- ADMINISTRATION
- Type of application: occlusive
- Application area: Scapular zones: homolateral (Induction site) and contralateral (challenge site)
- Description of patch: Finn's chamber standard (8 mm) (50 mm²)
Volume applied: 20 μL
The applications of the test raw material, the removal of the patches and the controls were peformed by the dermatologist or the technician in charge of the study.
- Induction phase: 3 consecutive weeks.
* application of the raw material to a perfectly delimited site, under patch on D1, D3, D5, D8, D10, D12, D15, D17, D19.
* patch removal
- after 48 h of contact on D3, D5, D10, D12, D17, D19.
- after 72h of contact on D8, D15, D22.
* controls: skin examination and questioning before patching on D1 and about 15 minutes (or more, if redness appeared after removal of the adhesive), after patch removal on D3, D5, D8, D10, D12, D15, D17, D19, D22.
- Rest period: 2 consecutive weeks at least (4 weeks at the most).
* no application of raw material.
- Ghallenge: 1 week,
* application of the raw material to a perfectly delimited virgin site and to the site defined for the induction phase, under patch on D36.
* patch removal after 48 h of contact on D38.
* controls: skin examination and questioning before patching on D36 and about 15 minutes (or more, if redness appeared after removal of the adhesive), after patch removal on D38, D39, D40 (48,72,96 h after application).
Confirmation of the compatibility (absence of irritant effect) and absence of allergenic potential
The expression of the results of the skin examination and questioning was that defined for this type of study in accordance with the corresponding procedure.
In case of reactivity:
- the main visible signs were noted, i.e. : Erythema, OEdema, Vesicle, Bulla, Papule, Scab, Dryness, Coloration, Soap effect.
The intensity of the erythema and oedema was assessed according to an ordinal scale: very slight, slight, moderate/ severe.
The appearance of the erythema was specified: diffuse, punctuated, peripheral (around the application site)
The importance of the number of vesicles and papules was assessed according to an ordinal scale:1 to 2 vesicles or papules, more than 2 vesicles or papules.
Bulla, scab, dryness, coloration and soap effect were described.
The importance of the dryness and coloration was assessed according to an ordinal scale: slight,moderate, severe.
- the main sensations of discomfort were described, i.e. : Heating, Stinging, Pruritus (itching).
The results were expressed:
- in percentage of reactive volunteers : for this calculation only the visible signs of reactivity were taken into account : erythema, oedema, vesicle, bulla, papule, scab.
- in a descriptive manner for the other visible signs or for the sensations of discomfort : when the frequency of appearance of these signs justified it, the percentage of reactive volunteers was possibly calculated.
interpretation:
All the volunteers included in the study were taken into account to confirm the skin compatibility of the test raw material as long as they were submitted at least to one post application examination at the defined time or else.
All the volunteers included in the study were taken into account to confirm the absence of allergenic potential of the test raw material (in absence of allergic reaction during the induction phase) as long as they were submitted to the challenge.
The interpretation of the results of the skin examination and questioning was that defined for this type of study in accordance with the corresponding procedure.
The possible reactions obserued during the induction phase were either irritation leactions or revelation of an allergy previously contracted or revelation of an allergy precociously induced by the test raw material.
The possible reactions obserued during the challenge on the "virgin" site were compared to those observed on the "induction" site at the same times. They were either irritation reactions or revelation of an allergy induced during the induction phase by the test raw material.
The natures, intensity, time of appearance, time of disappearance, location (induction site and/or virgin site) of the skin reaction were taken into account for the interpretation of the results.
To appreciate the skin compat¡b¡l¡ty and possible irritation reactions, the interpretation of the results, performed by the dermatologist, was absolute (referring to the experience of the investigator centre in this field and especially to the data acquired on products of same category tested under similar conditions). The test raw material could therefore have a very good, good, moderate or bad skin compat¡b¡l¡ty.
To appreciate the allergenic potential, the interpretation of the results was partly based on the allergenicity evaluation scale established by the ICDRG (International Contact Dermatitis Research Group) and took into account the visible reactions (clinical signs) and the possible reactions appeared on the control site:
NT : non tested
?+ : doubtful reaction, only slight erythema
+ : positive reaction (with no vesicle): efihema, infiltration, sometimes some papules
++ : strong positive reaction: presence of erythema, papules, vesicles
+++ : violent positive reaction: with presence of bullae
- : negative reaction
IR : irritation reaction
Results and discussion
- Results of examinations:
- Induction phase :
Type of rcacfivity on tle induction site : none
Number and percentage of reactive volunteers : 0 / 0%
Challenge phase :
Type of rcacfivity on tle induction site and virgin site : none
Number and percentage of reactive volunteers : 0 / 0%
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions adopted the repeated applications of the raw material under occlusive patch induced no reaction of initation and the raw material has a very good skin compatibility.
Moreover, the repeated applications induced no allergic reaction, - Executive summary:
A panel of 108 male and female human volunteers participated in a repeat insult patch test in which a test product applied to the back of the subjects under occlusive patches. 104 subjects completed the study.
During the induction or challenge phase, no skin reactions were observed.
Under the experimental conditions adopted the repeated applications of the raw material under occlusive patch induced no reaction of initation and the raw material has a very good skin compatibility.
Moreover, the repeated applications induced no allergic reaction,
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