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EC number: 843-143-1 | CAS number: 709647-81-4
- 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
Endpoint summary
Administrative data
Description of key information
In vitro skin sensitisation: Waived
In vivo skin sensitisation: Waived
Human skin sensitisation test (RIPT) (see Section 7.10.4): Negative for skin sensitisation
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in chemico or in vitro / ex vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. Available data to fulfil this endpoint were obtained from a Repeat Insult Patch Test Skin Irritation/Sensitisation study (RIPT) conducted on N-Glyceryl Arginine HCI.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. Available data to fulfil this endpoint were obtained from a Repeat Insult Patch Test Skin Irritation/Sensitisation study (RIPT) conducted on N-Glyceryl Arginine HCI.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
HRIPT - human skin sensitisation test (2005)
STUDY OBJECTIVE
To prove the absence of the skin sensitisation potential of a product applied to the skin, under maximized conditions, with controlled product amount and application site, supervised by a dermatologist.
METHODOLOGY
As per client requests, the test material K-7470 was diluted to 16.66% in distilled water. Dilutions were freshly prepared on each application day. 0.2 ml or 0.2g of the test material is dispensed onto the occlusive, hypoallergenic patch. The patch is then applied directly to the skin of the intrascapular regions of the back, to the right or left of the midline and the subject is dismissed with instructions not to wet or exposed the test area to direct sunlight. After 24 hours the patch is removed by the panellist at home. This procedure is repeated until a series of 9 consecutive 24 hour exposure have been made for every Monday, Wednesday, and Friday for three consecutive weeks. In the event of an adverse reaction, the area of erythema and edema is measured. The edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin. Reactions are scored just before applications two through nine and the next test date following application nine. In most instances this is approximately 24 hours after patch removal. Clients are notified immediately in the case of adverse reaction and determination is made as to treatment program if necessary. Subjects are given a 10 -14 day rest period after which a challenge or retest dose is applied once to the previously unexposed test site. The retest dose is equivalent to any one of the original nine exposures. Reactions were scored 24 and 48 hours after application. Comparison is made between the nine inductive responses and the test dose.
STUDY LENGTH
6 weeks
FREQUENCY OF APPLICATION
9 applications on the 3 first weeks (induction period).
1 application on the last week (challenge period).
APPLICATION SITE
Back (Scapular area).
NUMBER OF SUBJECTS
52 subjects completed the study.
POPULATION DESCRIPTION
Female and male, age range from 18 to 69 years old.
ETHICS
This study was conducted in conformance with the Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, Published by the Association of Food and Drug Official of The United States.
RESULTS
During the study, no subjects presented skin clinical signs related to the product.
CONCLUSION
The test material did not induce a skin sensitisation process in the study group when tested under occlusion at a 16.66% diluted in distilled water.
Therefore, the test material was considered as a non-irritant and non-primary sensitiser to the skin according to the reference (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, Published by the Association of Food and Drug Official of The United States).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test item does not meet the criteria for classification according to the Globally Harmonized Classification System or for the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.