Registration Dossier
Registration Dossier
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EC number: 947-802-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Human cutaneous vulvar reactivity to irritants
- Author:
- Marie B Britz and Howard I Maibach
- Year:
- 1 979
- Bibliographic source:
- Contact Dermatitis 1979: 5: 375-377
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 24 hours open clinical test in 21 volunteers
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-Benzyl-N,N-dimethyl-1-tridecanaminium chloride
- Cas Number:
- 8001-54-5
- Molecular formula:
- C22H40ClN
- IUPAC Name:
- N-Benzyl-N,N-dimethyl-1-tridecanaminium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- ethanol
- Reference substance name:
- Propane-1,2-diol
- EC Number:
- 200-338-0
- EC Name:
- Propane-1,2-diol
- Cas Number:
- 57-55-6
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propylene glycol
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- other: human
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: clipping the hair with scissors
- Vehicle:
- other: cosmetic formula with 17% benzalkonium chloride - see test material description
- Amount / concentration applied:
- 17% benzalkonium chloride
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 48 hours for 10 on 21 volunteers
- Number of animals:
- 21 human volunteers
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- forearm
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.19
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Remarks:
- vulva
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- sensitive vulvar skin
- Irritation parameter:
- erythema score
- Remarks:
- forearm
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- vulvar skin
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.07
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Score per animal is not available in the publication: mean values are presented. No edema score is presented.
The clinical inflamatory response varied from minimal erythema to marked erythema with slight vesiculation. The frequency of positive response (irritation index of 1 minimum) is 57 in vulvar test site and 9% in forearm test site.
Besides, a significant difference in skin reactivity is observed between forearm and vulvar sites.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- At a concentration of 17%, the clinical inflamatory response varied from minimal erythema to marked erythema with slight vesiculation. The frequency of positive response (irritation index of 1 minimum) is 57% in vulvar test site and 9% in forearm test site.
Besides, a significant difference in skin reactivity is observed between forearm and vulvar sites. - Executive summary:
In a clinical open test at 17% benzalkonium chloride in 21 human volunteers, the clinical inflamatory response varied from minimal erythema to marked erythema with slight vesiculation, and a significant difference in skin reactivity is observed between forearm and vulvar application sites.
The frequency of positive response (irritation index of 1 minimum) is 57% in vulvar test site and 9% in forearm test site.
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