Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

January 27, 2000 - March 17, 2000

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Not a validated method for determining skin irritation or skin sensitisation, but provides supporting information for “in-use” concentrations using a “standard practice” applied to ingredients for consumer formulations. It is a 9-days cumulative application for 24 hours, after which a rest period of approximately 2 weeks, a challenge patch was applied to a previously unpatched test site.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

GLP compliance:

no

Remarks:

(not applicable)

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide

EC Number:

271-794-6

EC Name:

Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide

Cas Number:

68608-66-2

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C11 alkyl) derivs. and sodium hydroxide and chloroacetic acid

Details on test material:

- Physical state: aqueous solution
- Appearance: clear liquid
- Composition of test material, percentage of components: see section confidential details on test material

Method

Type of population:

general

Ethical approval:

other: Informed Consent (CFR title 21, Part 50) was obtained from each human subject in the study

Subjects:

-A total of 109 human subjects started the study (14 males and 95 females ranging in age from 18 to 68 years)
-A total of 99 human subjects completed all phases of this study

Clinical history:

No data

Controls:

Not applicable

Route of administration:

dermal

Details on study design:

- Amount(s) applied (volume or weight with unit): 0.2 mL
- Concentration (if solution):
Separately reported: 0.5% of the aqueous solution (solid content: 0.15%)
INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hours
CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours

Results and discussion

Results of examinations:

no irritating nor sensitisation reactions observed

Any other information on results incl. tables

-Ten subjects (10/109) discontinued for personal reasons unrelated to the conduct of the study

-Scattered, transient, barely perceptible (+) to mild (1-level) non-specific patch test responses were observed on nine test panelists during the induction phase of the study

-During challenge phase, two test panelists exhibited barely perceptible responses at the 24- and/or 48-hour evaluations. There was no reactivity observed on either subject by the 96-hour evaluation

Applicant's summary and conclusion

Conclusions:

Under the conditions of a repeated insult (occlusive) patch test procedure, a 0.5% aqueous dilution of the aqueous solution of the test material (solid content 0.15%) did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.