Potassium (E,E)-hexa-2,4-dienoate

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

other: a retrospective study

Adequacy of study:

supporting study

Study period:

from1 January 1990 - 31 December 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Patch test data and data from the patients with history of dermatitis. Criteria was not specified

Justification for type of information:

Since the sorbate anion in the (eco-) toxicologically relevant moiety and its presence in dissociated or non-dissociated form is entirely determined by pH, extrapolation to potassium sorbate, the substance in question, is not considered to be restricted.

Data source

Reference

Reference Type:

publication

Title:

Patch testing with preservatives, antimicrobials and industrial biocides. Results from a multicentre study

Author:

Schnuch A., J.Geier, W.Uter and P.J.Frosch

Year:

1998

Bibliographic source:

British Journal of Dermatology 1998; 138: 467–476.

Materials and methods

Study type:

cohort study (retrospective)

Endpoint addressed:

skin sensitisation

Principles of method if other than guideline:

Clinical data collected from 01/01/1990 to 31/12/1994 from 24 departments of the Information Network of Departments of Dermatology Germany (IVDK). Patch test from 11,437 patients with allergic dermatitis were exposure 24 or 48 h to sorbic acid (Vehicle: petrolatum) and readout after 24 or 48 h (72 h after application). Reaction Index was calculated. Statistical analysis was performed using the SASTM system (SAS Institute, Cary, NC, U.S.A.) on the IBM host computer of the Department of Medical Informatics of the University of Göttingen.
Reaction Index: Reaction Index: "where the number of allergic reactions is related to the number of questionable and irritant reactions."

GLP compliance:

no

Test material

Specific details on test material used for the study:

not specified

Method

Type of population:

other: patients with history of dermatitis

Ethical approval:

not specified

Details on study design:

See principles of method if other than guidelines

Exposure assessment:

estimated

Details on exposure:

exposure 24 or 48 h to sorbic acid in petrolatum

Statistical methods:

not specified

Results and discussion

Results:

Of 11437 patient, 85 were positive (0.7 %), 93 with questionable or irritant reaction and a reaction index 0.0

Confounding factors:

not specified

Strengths and weaknesses:

not specified

Applicant's summary and conclusion

Conclusions:

Study cannot be used for classification. Description of response (mild/moderate/intense) not well described, results at different time points not well described, data are not sufficient to assess false positives.

Of 11437 patient, 85 were positive (0.7 %), 93 with questionable or irritant reaction and a Reaction.
Index 0.0.