Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: literature review
Adequacy of study:
key study
Study period:
2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data prepared by European Chemical Bureau.

Data source

Reference
Reference Type:
review article or handbook
Title:
European Union Risk Assessment Report CAS 60-00-4 EC 200-449-4 edetic acid (EDTA)
Author:
Europen Chemical Bureau Institute of Health and Consumer Protection
Year:
2004
Bibliographic source:
Europen Chemical Bureau Institute of Health and Consumer Protection

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: patch test
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
patch test concentration 1%
concentration of 1% in either petrolatum or water or 10% concentration in petrolatum

In vivo test system

Test animals

Species:
human

Results and discussion

Any other information on results incl. tables

Three out of 50 subjects showed a positive reaction to EDTA (patch test concentration 1%, Raymond and Gross, 1969). In another study after patch testing with a 1% EDTA concentration (Rudner, 1977), an incidence of 0.9% (positive responses of 215 subjects) was reported by the North American Contact Dermatitis Group without data on exposure to EDTA or other tested substances. Positive incidences of 1.7-2.8% (13/743 or 10/345 patients) were reported by Pevny and Schäfer (1980) and by Pevny et al. (1981). However the usual test concentration of 1% in either petrolatum or water (de Groot, 1986) was not used but a 10% concentration in petrolatum. Therefore, these data may not only suggest a contact allergy but also an irritating response. In 529 patients with eczematous dermatitis 2 (0.4%) showed a positive reaction to EDTA. It was not mentioned if the patients were exposed to EDTA (Angelini et al., 1985). According to Fisher (1986) not a single positive reaction in hundreds of patients who were tested with EDTA was observed. He concludes that EDTA is not a sensitiser and also does not crossreact with ethylenediamine hydrochloride.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
EDTA is not a sensitiser.
Executive summary:

Based on reports on humans studies and on the fact that the substance is being used in industry and consumer products for many decades in high quantities the incidences of positive responses is too low to warrant a labelling with H317 May cause an allergic skin reaction.