Magnesium, EDTA cobalt copper iron manganese zinc complexes

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

1.   Hypothesis for the analogue approach

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). In this case the related substances mentioned below are ingredients ofMagnesium, EDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

 

	Target Substance	Source Substance No 1	Source Substance No 2
Name	Magnesium, EDTA cobalt copper iron manganese zinc complexes	EDTA-FeNa	EDTA-CuNa2
CAS	234446-82-3	15708-41-5	14025-15-1
Sensitization	--	Not sensitizing	Not sensitizing

 

Lack of data for a given endpoint is indicated by “--“.

 

2.   Analogue approach justification

 

The above mentioned substances are considered to be similar on the basis of structural similarity resulting in similar properties and/or activities. The available endpoint information of the source substances are used to predict the respective endpoints forMagnesium, EDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3).

 

Since no studies are available forMagnesium, EDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3) investigating the skin sensitization,a read-across from the structurally related source substancesEDTA-FeNa (CAS 15708-41-5) and EDTA-CuNa2 (CAS 14025-15-1) was usedin accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5.

 

3.   Results

a.   Target Substance:EDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3)

There were no studies available with the target substance for skin sensitization.

 

b.   Source substances

 

-      Source Substance No1: EDTA-FeNa (CAS 15708-41-5)

In a local lymph node assay according to OECD guideline 426 the skin sensitization potential of EDTA-FeNa was evaluated (Haferkorn, 2007).Three concentrations of EDTA-FeNa (10%, 25% and 50%, w/w) dissolved inacetone/olive oil (4:1 v/v)were tested on the dorsum of each ear on 3 consecutive days in six female CBA mice per group and compared to a vehicle control group.On test day 4 lymph node cell count, ear weight (punch biopsies), ear swelling and weight of the lymph nodes were measured.

The stimulation indices of lymph node cell count and ear weight were 1.5 and 1.2, respectively.

EDTA-FeNa was considered not to be sensitizing.

 

-      Source Substance No2: EDTA-CuNa2 (CAS 14025-15-1)

The skin sensitizing potential of EDTA-CuNa2 was assessed in a murine local lymphnode assay according to OECD guideline No 429 (Otterdijk et al, 2013). Three experimental groups of five female CBA/J mice were treated with test substance concentrations of 10, 25 or 50% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (1% watery pluronic L92).No irritation of the ears was observed in any of the animals examined.White/grey test substance remnant were present on the dorsal surface of the ears of all animals at 10, 25 and 50% on Days 1-3, and at 50% also on Day 4 for one animal, which did not hamper scoring of skin reactions.

All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted in any of the animals. The SI values calculated for the substance concentrations 10, 25 and 50% were 0.9, 1.1 and 1.2 respectively.Since there was no indication that the test substance elicited an SI≥3 when tested up to 50%, EDTA-CuNa2 was considered not to be a skin sensitizer.

 

 

Key study assignment:

There is no information according the sensitizing potential available for the target substanceMagnesium, EDTA cobalt copper iron manganese zinc complexes. In a weight of evidence approach the sensitizing potential of the target substance was assessed via studies from two different source substances (Otterdijk, 2013 & Haferkorn, 2007), which are ingredients of the target substance. Those studies, are well documented, reliable and reveal a consistent negative result.

 

Conclusion

 

The source substancesEDTA-FeNa (CAS 15708-41-5) and EDTA-CuNa2 (CAS 14025-15-1) revealed negative results in guideline-conform studies andwould not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. Both source substances are ingredients of the target substance. It is not expected that other components of the target substance induce sensitization.

In conclusion, the available data on sensitization with structurally relatedsubstances, the target substance EDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3) is not considered to be a skin sensitizer.

 

 

 

 

Migrated from Short description of key information:
LLNA, OECD No 429, not sensitizing (Haferkorn, 2007& Otterdijk, 2013)

Justification for selection of skin sensitisation endpoint:
Weight of evidence approach with ingredients of the target substance.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Justification for classification

According to GHS (CLP-Regulation (EU) 1272/2008) and according to DSD-regulation (67/548/EEC) classification of the target substanceEDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3) as skin sensitizer is not warranted.

 

Labelling skin/respiratory sensitization:

 

GHS: no classification

DSD: no classification