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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, reasoably well documented publications

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Patch test reactions to a|preliminary preservative series
Author:
Brasch, J. et al.
Year:
1993
Bibliographic source:
Dermatosen Vol. 41 (2): 71-76.
Reference Type:
publication
Title:
Allergic contact dermatitis due to ingredients of vehicles
Author:
Fisher, A.A. et al.
Year:
1971
Bibliographic source:
Arch. Derm. Vol. 104: 286-290.
Reference Type:
publication
Title:
Unnamed
Year:
1966
Reference Type:
publication
Title:
Crux medicorum: Allergie gegen nicht deklarierte Salbenkonservantien
Author:
Klaschka, F. & Beiersdorff, H.U.
Year:
1965
Bibliographic source:
Münch. Med. Wschr. Vol. 107: 185-188.
Reference Type:
publication
Title:
Patch testing with preservatives, antimicrobials and industrial biocides. Results from a multicentre study
Author:
Schnuch, A. et al.
Year:
1998
Bibliographic source:
Brit. J. Dermatol. Vol. 138: 467-476.
Reference Type:
publication
Title:
Contact allergy to preservatives (I)
Author:
DeGroot, A.C. et al.
Year:
1986
Bibliographic source:
Contact Dermatitis Vol. 14: 120-122.
Reference Type:
publication
Title:
Epidemological survey of standard series patch test results and observations on day 2 and day 4 readings
Author:
Shehade, S.A. et al.
Year:
1991
Bibliographic source:
Contact Dermatitis Vol. 24: 119-122.
Reference Type:
publication
Title:
Contact dermatitis to sorbic acid
Author:
Ramsing, D.W. & Menné, T.
Year:
1993
Bibliographic source:
Contact Dermatitis Vol. 28: 124-125.
Reference Type:
publication
Title:
Skin reactions to preservatives in creams
Author:
Hjorth, N. & Trolle-Lassen, C.
Year:
1962
Bibliographic source:
American Perfumer Vol. 77: 43-46.
Reference Type:
publication
Title:
Unnamed
Year:
1976

Materials and methods

Principles of method if other than guideline:
Type of experience: immunological contact urticaria

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Results of examinations:
Sorbic acid only rarely produces allergic contact eczematous reactions, and is usually expected to involve an IgE-mediated spontaneous reaction towards the allergen. The clinical manifestation includes a localised weal-and-flare response after skin contact, and its capability to produce systemic effects in other organ systems also. The low incidence of such reactions has been reported:
Fisher et al. (1971) found only one patient with allergic hypersensitivity among 100 subjects. Klaschka (1966) reported sensitation to sorbic acid containing medications in 49 out of 1537 eczematous patients (sensitisation index 3.1%). Klaschka and Beiersdorff (1965) reported sensitisation to sorbic acid containing medications in only 5 out of 736 eczematous patients (sensitising index 0.6%).  In a multicentre study, Schnuch et al. (1998) investigated the allergenic potential of preservatives including sorbic acid. Based on patch testing in a total number of 11,437 subjects, only 0.7% reacted positively. DeGroot et al. (1986) recorded a sensitivity rate of 0.3% (2 out of 627). During the investigations of Shehade et al. (1991), 20 allergic patients occured out of 2912 (0.7%). 10 of 718 patients (1.4%) showed a positive result in the patch test reported by Ramsing and Menné (1993). Positive reactions occured in 10 out of 1489 patients exosed to 10% sorbic acid within three of four ointment bases (lipophile, w/o emulsion and o/w emulsion) (Hjorth and Trolle-Lassen, 1962). Brasch et al. (1993) assessed a sensitivity rate of 0.44% (9 out of 2044) in human subjects. Sensitivity to sorbic acid was detected in 0.8% of the cases, i.e. 5 out of 606 (Hannuksela et al., 1976). Brun (1975) reported 6 positive patch tests in 1000 cases (0.6%). 1% of 776 patch-tested patients showed positive reactions to sorbic acid (Iden  and Schroeter, 1977).

Applicant's summary and conclusion

Conclusions:
The extrapolation from sorbic acid to potassium sorbate is considered not to be restricted in any way, since the determinant of potential toxicity is the "sorbate anion".