Magnesium, EDTA cobalt copper iron manganese zinc complexes

Endpoint summary

Description of key information

Acute oral toxicity (rat): OECD No 401, LD50> 1740 mg/kg bw  (BASF, 2000)
Acute dermal toxicity (rat): OECD No 402 LD50>2000 mg/kg bw  (Haferkorn, 2007)
Acute inhalative toxicity (rat): OECD No 403, LC50 >5.1 mg/m3 (BASF, 2014)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

1 740 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

5.1 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

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).

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
Name	Magnesium, EDTA cobalt copper iron manganese zinc complexes	EDTA-FeNa
CAS	234446-82-3	15708-41-5
Acute oral toxicity	LD50 > 2000 mg/kg	--
Acute inhalation toxicity	LC50 > 5.1 mg/l	--
Acute dermal toxicity	-- (Waiver)	LD50 > 2000 mg/kg

 

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. Furthermore, EDTA-FeNa is one ingredient (25%) of the target substance (CAS 234446-82-3).

 

Since no studies investigating the acute dermal toxicity are available forMagnesium, EDTA cobalt copper iron manganese zinc complexes(CAS234446-82-3), a read-across from the structurally related analogueEDTA-FeNa (CAS 15708-41-5) was usedin accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5.

 

 

3.   Results

3.1 Oral

a.   Target Substance:

EDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3)

The acute oral toxicity of the test substance was evaluated according to OECD guideline No 401 (BASF 2000) in male and female Wistar rats (5 of each sex/dose) when administered as a single gavage dose at a Ievel of 2000 mg/kg of body weight. No mortality or other abnormalities were observed during the study. Thus, the LD50 (oral) is >2000 mg/kg bw.

3.2 Inhalation

a.   Target Substance:

EDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3)

The acute inhalation toxicity of the test substance was evaluated according to OECD guideline No 403 (BASF 2014). Wistar rats (5 of each sex/concentration)) received Magnesium, EDTA cobalt copper iron manganese zinc complexes as a dust aerosol (single exposure, 4h, nose only) at concentrations of 2.413 mg/L and 5.107 mg/L (analytical concentrations).

No mortality occurred at the tested concentrations and at the end of the post exposure observation period no clinical signs of toxicity or abnormalities were noted.

Under the current study conditions the LC50 was > 5.1 mg/L in male and female Wistar rats.

 

3.3 Dermal

               b.   Source substances

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

Data are available for the oral and inhalation routes of exposure. In accordance with REACH Regulation 1907/2006, Annex VIII, Column 2 testing by the dermal route is necessary if the physicochemical and toxicological properties suggest the potential for significant dermal absorption. However, dermal absorption of EDTA and its salts is expected to be poor (<0.001%) and there is therefore no requirement to test.

To show that the acute dermal toxicity is low, an acute dermal toxicity according to OECD guideline No 402 with the read-across substance EDTA-FeNa is included (W. Neudorff GmbH KG, 2007). Intact skin of 5 rats per sex was exposed with 2000 mg/kg bw EDTA-FeNa in water for 24h under occlusive conditions. No mortality or other adverse effects were noted, no clinical signs, no effects on body weight, no local signs and no adverse findings at final necropsy after a 14 days observation period.

The LD50 (rat, dermal) exceeded 2000 mg/kg bw.

 

Key study assignment:

 

a)   acute oral toxicity

There is one acute oral toxicity study available for the target substanceEDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3), which is well documented, reliable and was conducted in general accordance with the OECD principles of GLP. Therefore this study (BASF, 2000) was assigned as key study.

 

b)   acute inhalation toxicity

There is one acute inhalation toxicity study available for the target substanceEDTA cobalt copper iron manganese zinc complexes(CAS 234446-82-3), which is well documented, reliable and was conducted in general accordance with the OECD principles of GLP. Therefore this study (BASF, 2014) was assigned as key study.

 

c)   acute dermal toxicity

Dermal absorption of EDTA and its salts is expected to be poor (<0.001%) and there is as above mentioned therefore no requirement to test.A supporting acute dermal toxicity study is available for the read-across substanceEDTA-FeNa (CAS 15708-41-5), which is well documented, reliable and was conducted in general accordance with the OECD principles of GLP. This study (BASF, 2014) was referenced as supporting study.

 

Conclusion

In summary the available data indicate a low acute oral toxicity LD50> 2000mg/kg bw, a low acute inhalation toxicity with an LC50>5.1 mg/L/4h and no acute toxicity via dermal route (LD50 > 2000 mg/kg bw).

Justification for selection of acute toxicity – oral endpoint
Most relevant and reliable study.

Justification for selection of acute toxicity – inhalation endpoint
Most relevant and reliable study.

Justification for selection of acute toxicity – dermal endpoint
Most significant routes already covered. Nevertheless additional information from read across added.

Justification for classification or non-classification

Justification for classification

Based on the information received for the target substance and structurally similar source substances, no classification is justified according to Regulation (EC) 1272/2008 or Directive 67/548/EEC,

GHS: no classification

DSD: no classification