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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
other: Medical data
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:
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:
1985
Reference Type:
publication
Title:
Non-immunological contact urticaria
Author:
Lahti, A.
Year:
1980
Bibliographic source:
Acta Derm. Venereol. Vol. 60, Suppl. 91: 1-49.
Reference Type:
publication
Title:
Unnamed
Year:
1987
Reference Type:
publication
Title:
Release of markedly increased|quantities of prostaglandin D2 from the skin in vivo in humans following the application of sorbic acid
Author:
Morrow, J.D. et al.
Year:
1994
Bibliographic source:
Arch. Dermatol. Vol. 130: 1408-1412.
Reference Type:
publication
Title:
Prostaglandin D2 mediates contact urticaria caused by sorbic acid, benzoic acid, and esters of nicotinic acid
Author:
Roberts, L.J. & Morrow, J.D.
Year:
1997
Bibliographic source:
Contact Urticaria Synd. 1997: 77-88.
Reference Type:
publication
Title:
Sorbic acid- induced erythema and edema
Author:
Soschin, D. et al.
Year:
1986
Bibliographic source:
J. Am. Acad. Dermatol. Vol. 14: 234-241.

Materials and methods

Type of study / information:
Type of experience: non-immunological contact urticaria

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Results:
A generally low incidence (<1%) of non-immunological contact urticaria is reported in investigations involving patch testing with a large number (>100) of patients, as summarised below:
This form of urticaria related to sorbic acid and sorbates often involves either histamine or prostaglandins as mediators (Soschin et al., 1986). 
It occurs without previous sensitisation, and symptoms remain localised to the contact site, and do not spread to become generalised urticaria or elicit systemic effects (Lahti and Maibach, 1987).
Morrow et al. (1994), and Roberts and Morrow (1997) describe the release of markedly increased (250-620-fold) quantities of prostaglandin D2 from human skin after exposure to sorbic acid in comparison to untreated skin.
14% of the patients showed immediate reactions after treatment with 2.5% sorbic acid (Lahti, A., 1980). Gollhausen and Kligman (1985) confirmed the urticariogenicity of sorbic acid with the NICU test.

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".