Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 204-526-3 | CAS number: 122-18-9
Endpoint summary
Administrative data
Description of key information
0.1% aqueous Test chemical was not sensitizing to human skin.
Hence, Test chemical can be 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:
- weight of evidence
- 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 journals
- Qualifier:
- according to guideline
- Guideline:
- other: Patch test
- Principles of method if other than guideline:
- Patch test were performed to determine the irritation and allergenic potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
- Specific details on test material used for the study:
- - Name of test material: Cetalkonium chloride
- IUPAC name: CETYL DIMETHYL BENZYL AMMONIUM CHLORIDE
- Molecular formula: C25H46ClN
- Molecular weight: 396.098 g/mole
- Smiles Notation: c1(C[N+](CCCCCCCCCCCCCCCC)(C)C)ccccc1.[ClH-]
- InChl: 1S/C25H46N.ClH/c1-4-5-6-7-8-9-10-11-12-13-14-15-16-20-23-26(2,3)24-25-21-18-17-19-22-25;/h17-19,21-22H,4-16,20,23-24H2,1-3H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid crystalline powder (white) - Species:
- other: humans
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- - Source: Department of Dermatology, Free University Academic Hospital, Netherlands
- Age at study initiation: 28-year-old - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1% aqueous
- Day(s)/duration:
- 72 hours
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 72 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 1
- Clinical observations:
- No dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- 0.1% aqueous the test chemical was not sensitizing to human skin.
Hence, the test chemical can be considered to be not sensitizing to skin. - Executive summary:
Patch tests were performed to determine the irritation and allergenic potential of the test chemical.
A 28-year-old male had recurrent itchy dermatitis on the left side of the chest and adjacent area of the arm, where his wife usually rested her head when sleeping. He had noted that the eruption always developed after his wife had used a hair conditioner.
Patch tests with the European standard sense (ICDRG) and the conditioner (tested undiluted) showed a positive reaction only to the conditioner. Later its ingredients and additional quaternary ammonium salts were also tested separately.
0.1% aqueous the test chemical was not sensitizing to human skin.
Hence, the test chemical can be considered to be not sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin Sensitization:
Various patch tests have been summarized to ascertain the extent of dermal sensitization caused by test chemical.
Patch tests were performed to determine the irritation and allergenic potential of cetalkonium chloride.
A 28-year-old male had recurrent itchy dermatitis on the left side of the chest and adjacent area of the arm, where his wife usually rested her head when sleeping. He had noted that the eruption always developed after his wife had used a hair conditioner.
Patch tests with the European standard sense (ICDRG) and the conditioner (tested undiluted) showed a positive reaction only to the conditioner. Later its ingredients and additional quaternary ammonium salts were also tested separately.
0.1% aqueous Test chemical was not sensitizing to human skin.
Hence, Test chemical can be considered to be not sensitizing to skin.
This is supported by the results of other patch test performed according to recommendations of the International Contact Dermatitis Research Group and the German Contact Dermatitis Group. Finn Chambers on Scan-por were used. Patches containing 0.1% test chemical in petrolatum were applied to patient skin for 48 hours. Readings were done until at least 72 h after application of the test chambers. For this study, only readings at 72 h were considered.
A reaction index (RI) was calculated, where the number of allergic reactions is related to the number of questionable and irritant reactions.
Positive reactions were observed in 26 of the 11237 i.e (0.2%) patients tested.
Hence, test chemical can be considered to be not sensitizing to skin.
The above studies are further supported by another patch test performed using 0.01% aqueous solution of test chemical. 0.01% aqueous solution of test chemical was applied to the upper backs or forearms of the various patients. 18 patients were used as controls and tested with 10% aqueous solution. Pricks test were performed for controls.
Contact dermatitis was observed in only 3 patients of the various patients tested.
Hence, test chemical can be considered to be not sensitizing to skin.
Available studies for Test chemical indicate a strong possibility of it being not sensitizing to skin. Hence, test chemical 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.
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.
