Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1998

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Limited information

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Efficacy of DPTA (diethylenetriamine pentaacetate) a chelator in the prevention of contact dermatitis to metals

Author:

Goetz, M.

Year:

1998

Bibliographic source:

Annual Meeting of the European Academy of Allergology and Clinical Immunology, Birmingham, England, Uk, June 21-26, 1998. Allergy (Copenhagen)

Materials and methods

Type of sensitisation studied:

skin

Study type:

survey

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid)

EC Number:

200-652-8

EC Name:

N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid)

Cas Number:

67-43-6

IUPAC Name:

N,N-bis{2-[bis(carboxymethyl)amino]ethyl}glycine

Details on test material:

- Name of test material: DTPA incorporated in Excipial - Hydrocream (oil in water emulsion)

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

18 subjects with multiple metal hypersensitivities were patch tested with various metals (Ni 2.5 and 5%, Cu 2%, Co 1%, Cr 0.5%, Pd 1%) on their upper arms with and without chelator pretreatment

Clinical history:

18 subjects with multiple metal hypersensitivities were patch tested with various metals (Ni 2.5 and 5%, Cu 2%, Co 1%, Cr 0.5%, Pd 1%) on their upper arms with and without chelator pretreatment

Controls:

no data

Route of administration:

dermal

Details on study design:

Testing was performed in a double-blind, randomized and placebo-controlled manner with an application time of 24 hours. Readings were taken after 24 and 72 hours.

Results and discussion

Results of examinations:

DTPA was able to suppress patch test reactions to Ni 2.5% in 16/16 (100%), to Ni 5% in 8/16 (50%), to Cu in 4/4 (100%), to Cr in 3/6 (50%), to Co in 7/11 (63.6%) and to Pd in 7/13 cases (53.85%). When DTPA was not able to completely inhibit the reactions, it significantly reduced the severity of the reactions

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:

Under the conditions of the study, the results showed that DTPA was not only effective in inhibiting nickel-induced contact dermatitis but is also effective with other metal ions.