Edetic acid

Skin sensitisation

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

Guideline:

other: patch test

GLP compliance:

not specified

Type of study:

patch test

Test material

Test material information

Constituent 1

Reference substance name:

Edetic acid

EC Number:

200-449-4

EC Name:

Edetic acid

Cas Number:

60-00-4

Molecular formula:

C10H16N2O8

IUPAC Name:

2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetic acid

Constituent 2

Reference substance name:

EDTA

IUPAC Name:

EDTA

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.