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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of the test substance
Author:
Cosmetic Ingredient Review Expert Panel
Year:
1989
Bibliographic source:
Journal of the American College of Toxicology, 1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Patch test
Principles of method if other than guideline:
Patch test was performed to determine the allergenic potential of the test chemical when applied to the skin as a part of the formulation
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzalkonium chloride
EC Number:
616-786-9
Cas Number:
8001-54-5
Molecular formula:
unspecified
IUPAC Name:
Benzalkonium chloride
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): benzalkonium chloride
- Molecular weight : 170.662 g/mol
- Substance type: Organic
- Physical state: Solid

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Age: 18-65 years old

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
not specified
Concentration / amount:
0.1 ml of 0.1% test chemical as a cream formulation
Day(s)/duration:
3 times per week for 3 weeks and on Monday of week 4
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
not specified
Concentration / amount:
0.1 ml of 0.1% test chemical as a cream formulation
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
101 male/female volunteers
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 weeks of testing, patches were applied on Mondays, Wednesdays, and Fridays and on Monday of week 4
- Exposure period: 24 hours
- Test groups: 101
- Control group: no data available
- Site: back or arm
- Frequency of applications: 3 times per week for 3 weeks and on Monday of week 4
- Duration: 24 hours
- Concentrations: 0.1 ml of 0.1% test chemical as a cream formulation

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: week 6
- Exposure period: 48 h
- Test groups:101
- Control group:
- Site: back or arm
- Concentrations: 0.1 ml of 0.1% test chemical as a cream formulation
- Evaluation (hr after challenge): 48 and 72 hours after application

OTHER: Reactions were scored after patch removal according to the following scale: 0 (negative), 1 + (erythema), 2 + (erythema and edema or induration), 3 + (erythema, edema/induration and vesiculation), and 4 + (erythema, edema/induration, bulla, with or without ulceration).
Challenge controls:
no data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1 ml of 0.1% test chemical as a cream formulation -
No. with + reactions:
0
Total no. in group:
101
Clinical observations:
No signs of irritation or sensitization observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
No significant reactions were observed during induction or challenge phases. Hence, the test chemical was considered to be not sensitizing to skin when tested as a part of cream formulation.
Executive summary:

Patch test was performed to determine the allergenic potential of the test chemical when applied to the skin as a part of the formulation.

A cream containing 0.1% test chemical (approx. 0.1 ml) was applied via a semi-occlusive patch to the back or arm of 101 men and women (18-65 years old).During a 6-week period. During the first 3 weeks of testing, patches were applied on Mondays, Wednesdays, and Fridays and removed 24 h after application.The last induction patches were applied on Monday of week 4 and removed 24 h later. Reactions were scored 48 h after patch removal.

After a rest period of one week, on the Monday of week 6, a challenge patch was placed on each subject (new site) and removed 48 h later. Reactions were scored 48 and 72 h after application.

Reactions were scored after patch removal according to the following scale: 0 (negative), 1 + (erythema), 2 + (erythema and edema or induration), 3 + (erythema, edema/induration and vesiculation), and 4 + (erythema, edema/induration, bulla, with or without ulceration).

No significant reactions were observed during induction or challenge phases. Hence, the test chemical was considered to be not sensitizing to skin when tested as a part of cream formulation.