Acetic acid, 2-oxo-, reaction products with ethylenediamine, iron chloride (FeCl3) and phenol, potassium salts

Endpoint summary

Description of key information

Severel studies available

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are two studies at hand that evaluate skin sensitizing potential of FeNaEDDHA: The skin sensitisation potential of FeNaEDDHA was examined in the Maximisation Test of Magnusson and Kligman (GPMT) in guinea pigs according to the OECD Guideline 406. Under the experimental conditions employed, 20 and 55% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. The test substance could therefore be considered to have a (weak) sensitisation potential (sensitiser) in the GPMT. In a Local Lymph Node Assay (LLNA), the possible skin sensitization potential of FeNaEDDHA was determined according to the OECD Guideline 429 and the Commission Directive 2004/73/EC B.42. In this study, Stimulation Indices of 1.59, 2.89, and 2.99 were determined at concentrations of 5, 10 and 25 % in dimethylformamide, respectively. A statistically significant increase in DPM/animal and in lymph node weights was observed in all treated groups in comparison to the vehicle control group (p=0.008). A dose response was present. The results for this test item FeNaEDDHA was found to be ambiguous for skin sensitiser under the test conditions of this study.

However, it is noted that FeNaEDDHA does not interact with protein, which is considered a requirement for sensitization (needed for haptenisation). Moreover, also decades of use of this substance did not result to any reports of people becoming sensitized.

Studies were also available for the methylated structural analogue FeEDDHMA (see also section 13). Six out of eight guinea pig maximisation tests showed no skin sensitising properties of FeEDDHMA. All these tests (except for one, Kynoch (1977), pre-GLP) were carried out according to OECD 406 and according to GLP. Two older tests, however, showed skin sensitising properties. One test was carried out in 1990 (Smith), also carried out according to GLP and OECD 406; the other test (Skydsgaard, 1987) was not carried out according to GLP and was a modification of the Magnusson and Kligman test using four topical applications. The fact that more recent studies using higher induction and challenge concentrations did not show sensitising properties whereas two older studies did, allows the conclusion that the older products may have contained one (or more) impurity (/impurities) that had sensitising properties. Overall it is, therefore, concluded that FeEDDHMA is not a skin sensitiser. In addition it is noted that FeEDDHMA does not interact with protein, which is considered a requirement for sensitization (needed for haptenisation). Finally, also decades of use of this substance did not result in any reports of people becoming sensitized.

Overall, in those (older) studies were positive results were seen, the conclusion is allowed that the products tested may have contained one (or more) impurity (/impurities) that had sensitising properties. Overall it is, therefore, concluded that Fe-EDDHMA and FeNaEDDHA are not skin sensitisers; the same would therefore apply to FeKEDDHA.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Because FeKEDDHA is not considered to have skin sensitizing properties, it is not expected it will be a respiratory sensitizer either.

Justification for classification or non-classification

Six available studies (OECD 406 and GLP) did not indicate sensitising properties of FeEDDHMA. Two older studies indicate either a possible weak, or an ambiguous result for a weak potential for sensitisation of EDDHMA-Fe. Two available studies indicate either a possible weak, or an ambiguous result for a weak potential for sensitisation of FeNaEDDHA. .

The substances do not interact with protein and years of use of this substance did not result in any reports of people becoming sensitized.

In conclusion, in the evaluation of all available information, the conclusion seems to be allowed that that the (older) products may have contained one (or more) impurity (/impurities) that had sensitising properties. FeEDDHMA and FeNaEDDHA are therefore not classified with regard to sensitisation according to Regulation (EC) No 1272/2008 (CLP). This would therefore also apply to FeKEDDHA (see read across document in section 13).