Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 249-120-7 | CAS number: 28645-51-4
- 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
Skin Sensitization:
A patch test was conducted for test chemical on 422 patients suspected with contact allergy who visited the hospitals over the period April 2002 to June 2003 in 9 university hospitals in Korea. Each patient was exposed to 5% of test chemical in petrolatum by using Finn Chambers on Scanpor tape (Epitest, Tuusula, Finland) for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Skin sensitization study was conducted to evaluate the toxic nature of the test compound.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ambrettolide
- Molecular formula : C16H28O2
- Molecular weight : 252.395 gram/mol
- Substance type: Organic
- Physical state: Liquid - Species:
- other: human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Patients with suspected contact dermatitis from 9 university hospitals in Korea
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From April 2002 to June 2003 - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5%
- Day(s)/duration:
- no data available
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5%
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 422 Korean patients
- Details on study design:
- Finn Chambers on Scanpor fape (Epitest, Tuusula, Finland) tape was used for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.
- No. of exposures: No data available
- Exposure period: No data available
- Test groups: 422
- Control group: No data available
- Site: Most common site was the Face. Neck, trunk, eyelid, lips, hand, arm, leg, scalp, ear, foot and widespread areas were also evaluated.
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: 5% - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 422
- Clinical observations:
- Negative result were observed in 422 patients.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitising
- Conclusions:
- No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.
- Executive summary:
A patch test was conducted for test chemical on 422 patients suspected with contact allergy who visited the hospitals over the period April 2002 to June 2003 in 9 university hospitals in Korea. Each patient was exposed to 5% of test chemical in petrolatum by using Finn Chambers on Scanpor tape (Epitest, Tuusula, Finland) for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been summarized to determine the allergenic potential of the test chemical in living organisms.The studies are based on in vivo experiments in guinea pigs as well as humans for the various test chemicals.
Study 1:
A patch test was conducted for test chemical on 422 patients suspected with contact allergy who visited the hospitals over the period April 2002 to June 2003 in 9 university hospitals in Korea. Each patient was exposed to 5% of test chemical in petrolatum by using Finn Chambers on Scanpor tape (Epitest, Tuusula, Finland) for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.
Study 2:
This is supported by the results of a Repeated Insult Patch Test (RIPT) conducted to determine if test chemical would induce dermal sensitization in human volunteers. During the induction phase 0.5 ml of 0.5% (382µg/cm2) of chemical in ethanol was applied onto the upper arm of 38 human volunteers for 24 hours in a 1 x 1 semi-occlusive patch. The applications were made to the same site on Monday, Wednesday and Friday for a total of nine applications during 3-week period. Following a 10-day rest period, a challenge patch was applied to a site previously un-exposed. Patches were applied as in the induction phase and kept in place for 24 h after which time they were removed. Reactions to the challenge were scored at 24 and 72 hours after application. None of the volunteers developed skin sensitization reactions at 24 and 72 hrs after challenge exposure. The test material was considered to be not sensitizing on human volunteers.
Study 3:
These results are supported by an Open epicutaneous test conducted on Guinea Pigs to evaluate the skin sensitization potential of the test chemical. During the test, 6-8 guinea pigs were induced with the test chemical at concentration of 100, 30, 10, 3, 1% which was followed by challenge exposure of 1% applied dermally.
Since none of the treated animals showed skin reactions at challenge concentration, the test chemical was considered to be not sensitizing on guinea pigs’ skin.
Study 4:
The above results are further supported by the Human maximization test carried out in 26 volunteers to assess the skin sensitizing behavior of test chemical. About 1% of the test chemical in petrolatum was applied on each volunteer. None of the volunteers showed any cutaneous reaction, hence, the test chemical considered to be not sensitizing to the human skin.
Study 5:
These results are lent support by another Repeated Insult Patch Test (RIPT) conducted to determine the skin sensitization potential of test chemical in 58 volunteers. Each subject were exposed to 2% of the test chemical in DMP under occlusive condition and then observed for 48-72 hours for skin reactions. Negative skin reactions were observed after 72 hours. Hence the test chemical was considered to be not sensitizing to the human skin.
Study 6:
These results are also supported by the human maximization test was conducted on 25 volunteers for test chemical to determine the skin irritancy potential caused by the chemical. During the test, 30% of test chemical in petrolatum was applied on skin of each volunteer followed by observation of skin reactions.
It was noted that none of the 25 volunteers had developed any skin lesions or allergic reaction. Hence the test chemical was not sensitizing to the human skin.
Available studies for test chemical indicate that it lacks the potential to cause any dermal reaction to the skin. Hence, it can be considered to be not sensitizing to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Available studies for the test chemical indicate that it is not likely to cause any dermal sensitization. Hence, the test chemical can be considered to be not sensitizing to skin as per the CLP classification.
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.