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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Study period:
- 17-Oct-2018 to 30-Nov-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Repeated Insult Patch Test (RIPT) - Shelanski Method
- GLP compliance:
- no
Test material
- Reference substance name:
- Curcuma longa, essential oil obtained by steam distillation of the leaves
- Molecular formula:
- No applicable for UVCB substance
- IUPAC Name:
- Curcuma longa, essential oil obtained by steam distillation of the leaves
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- 2wt% in mixed solvent Ethanol/Diethyl Phthalate (1:3 weight ratio)
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- A total of 114 male and female subjects, ranging in age from 19 to 71 years and in generally good health, were selected for the study. Subjects who met all of the inclusion criteria and none of the exclusion criteria listed in the study protocol were enrolled for participation.
INCLUSION CRITERIA
a. Subject is male or female between the ages of 18 and 70 years;
b. Female subjects who are sexually active are using adequate method of birth control;
c. Subject does not exhibit any skin diseases which might be confused with a skin reaction from the test material;
d. Subject agrees to avoid exposure of the test sites to the sun and to refrain from visits to tanning salons during the course of this study;
e. Subject is absent of any visible or known pre-existing skin disease which might be confused with a skin reaction from the test material, or which may be reasonably expected to affect the outcome of the study. This includes psoriasis or active eczema even if currently controlled through medication.
f. Subject agrees to refrain from getting patches wet and from scrubbing or washing the test area with soap or applying powder, lotions or personal care products to the area during the course of the study;
g. Subject has signed an Informed Consent in conformance with 21CFR Part 50: “Protection of Human Subjects;”
h. Subject has completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
i. Subject is in generally good health and has a current Subject Profile
j. Subject is dependable and able to follow directions as outlined in the protocol.
EXCLUSION CRITERIA
a. Subject is pregnant, nursing, or planning to become pregnant, or not using adequate birth control;
b. Subject is currently using any systemic or topical corticosteroids, anti-inflammatory drugs, or antihistamines on a regular basis;
c. Subject reports allergies to cosmetics, toiletries, or personal care products;
d. Subject exhibits any skin disorders, sunburn, scars, excessive tattoos, etc. in the test area;
e. Subject has scheduled, or is planning to undergo, any medical or surgical procedures during the 6-week course of the study. - Controls:
- distilled water, 2wt% in mixed solvent Ethanol/Diethyl Phthalate (1:3 weight ratio)
- Route of administration:
- dermal
- Details on study design:
- The study consisted of an induction phase, a challenge phase, and, at the discretion of the Principal Investigator and at the approval of the Sponsor, a Re-Challenge Test. During the Induction Phase, the test materials were applied to the same location on the back of each subject three times per week for a total of nine applications, with 24-hour rest periods, except Fridays, in between applications, or as specified in Section 10.0. Test sites were examined for dermal irritation at each visit prior to reapplication of the test materials. Approximately 10 to 21 days after the Induction Phase, subjects returned to the laboratory for the Challenge Phase. The test materials were applied to virgin sites on the back under the appropriate patch type, and were removed by clinic staff approximately 24 hours later. Test sites were examined for signs of dermal irritation or sensitization. At the discretion of the Principal Investigator and with the Sponsor’s approval, a subject may have been required to return to the lab for a Re-Challenge Test if reactions indicative of sensitization were observed during the Challenge Phase. During the Re-Challenge Phase, the test material was applied to a virgin site on the upper arm or back under the same conditions of the Challenge Phase and the subject was examined for dermal reactions. At the Sponsor’s request, additional products (“omission products” or individual components) may have been tested and/or other conditions may have been used.
Results and discussion
- Results of examinations:
- No adverse events were reported during the study.
Any other information on results incl. tables
This study was initiated with 114 subjects. Nine subjects discontinued study participation for reasons unrelated to the test material. A total of 105 subjects completed the study.
Applicant's summary and conclusion
- Conclusions:
- Based on the test population of 105 subjects and under the conditions of this study, the test material and the control did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.15ml of the test material applied to a 3.63 cm2 occlusive patch.
- Executive summary:
One hundred and fourteen subjects participated in evaluating the potential of Turmeric leaf oil (2wt% in Ethanol/Diethyl Phthalate 1:3 weight ratio) to elicit dermal irritation and/or induce sensitization. Distilled water (2 wt% in Ethanol/Diethyl Phthalate 1:3 weight ratio) served as control. The test material and control were applied under occlusive patch to the upper back of each subject and were allowed to remain in direct skin contact for a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. The sites were graded by a Eurofins CRL, Inc. technician for dermal irritation 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday.
Approximately 10 to 21 days after the Induction Phase, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a Eurofins CRL, Inc. technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours after application. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading.
One hundred and five subjects completed the study. The test material and the control did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.15ml of the test material applied to a 3.63 cm2 occlusive patch.
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