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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- Human single patch test using generallyaccepted methods performed according to Good Clinical Practice
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 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 single patch test using generally-accepted methods performed according to Good Clini cal Practice
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Type of study / information:
- Acute skin tolerance on volunteers
- Endpoint addressed:
- skin irritation / corrosion
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Skin irritation potential of the test item was studied in volunteers using 48 hour single patch test and skin reactions were evaluated
- GLP compliance:
- no
- Remarks:
- study has been conducted in the spirit of the good Clinical Practice
- Specific details on test material used for the study:
- Tested diluted at 15% in water
- Ethical approval:
- confirmed and informed consent free of coercion received
- 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 experimental area was the back. The site of application of the product was chosen by the dermatologist or by the technician in charge of the study. Skin appearance was taken into account and the areas of friction with clothes were avoided. Many other products were tested concurrently, so the concerned product was applied by the investigator or the responsible technician, to one of the sites localized by a clockwise distribution, altering of one rank from a subject to another.
The product had to be in contact with skin , under patch, for 48 +/- 5 hours.
The patch removal had to be performed by the investigator or the responsible technician.
The contact time and the modalities of removal, defìned in the protocol, were respected.
The skin examination and joint questioning had to be peformed by the dermatologist or the responsible technician.
This examination had to be performed visually under standard "daylight" source, 15 minutes (or more if some redness appeared after patch removal), after patch removal.
All the examinations were performed in accordance with the conditions defined in the protocol.
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 : absence, 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 : absence, 1 to 2 vesicles or papules, more than 2 vesicles or papules.Bullae, scab, dryness, coloration and soap effect were described,
The impoftance of the dryness and coloration was assessed according to an ordinal scale : absence, very slight, slight, moderate, severe.
the main sensations of discomfolt 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 : erythema, oedema, vesicle, bulla, papule, scab, were taken into account.
* in a descriptive manner for the other visible signs or for the sensations of discomfort : if the frequency of appearance of these signs justified it, the percentage of reactive volunteers was calculated.
* in score of skin irritation, calculated from the "marks" allocated to the visible signs : erythema, oedema, vesicle, papule (from I to 2 or 3) and bulla, scab (2 if presence) which took into account the intensity of the skin reactions.
For each volunteer, an individual daily irritation score (Idis) was calculated : sum of all the marks obtained for the observed signs.
For the panel, a mean daily irritation score (Mdis) was calculated according to the formula :
Mdis = E (Idis) / number of volunteers (exploitable data)
All the volunteers included in the study were taken into account to check the skin compatibility of the test product as long as they were submitted at least to one post application examination at the defined time or else.
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,
This interpretation, performed by the investigator, was absolute, The test product could therefore have a very good, good, quite good, moderate or bad skin compatibility.
The possible reaction observed were either reactions of irritation or the revelation of an allergy previously acquired, - Exposure assessment:
- measured
- Details on exposure:
- CF. study design
- Results:
- After patch test removal, there is no reactive volunters. the mean daily irritation score Mdis is 0.
- Conclusions:
- Under the experimental conditions adopted, the product has a very good skin compatibility.
- Executive summary:
Under the experimental conditions adopted, the product has a very good skin compatibility.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
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