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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Sensitisation data (human)

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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

Constituent 1
Chemical structure
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.