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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
Reference
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.

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.