Ethylenediamine-N,N'-di(acetic acid)

Endpoint summary

Description of key information

Acute oral toxicity - Weight of evidence suggests the median lethal dose to be close to 2000 mg/kg. In the absence of reliable data on the substance itself a key, well documented study, on the analogue tetrasodium EDTA describes the LD50 of that substance as being 1780 mg/kg. This is used to characterise the acute toxicity of this substance and the LD50, re-based according to the molecular weight of the two substances, is therefore taken as being 1303 mg/kg.

Acute inhalation toxicity - The LC50(4h) for the structurally related substance Na3-HEDTA is in excess of 3.95 mg/L, the highest exposure concentration achievable.

Acute dermal toxicity - No relevant data available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 303 mg/kg bw

Quality of whole database:

A number of studies are available regarding acute oral toxicity providing a weight of evidence that suggests that the LD50 is close to 2000 mg/kg. In the absence of reliable data on the substance itself a key, well documented study, on the analogue tetrasodium EDTA describes the LD50 of that substance as being 1780 mg/kg. This is used to characterise the acute toxicity of this substance and the LD50, re-based according to the molecular weight of the two substances, is therefore taken as being 1303 mg/kg.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

3 950 mg/m³ air

Quality of whole database:

Single study available on the the structurally related substance Na3-HEDTA.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

No reliable studies available

Additional information

A number of studies is available regarding acute oral toxicity providing a weight of evidence that suggests that the LD50 is close to 2000 mg/kg. In the absence of reliable data on the substance itself a key, well documented study, on the analogue tetrasodium EDTA describes the LD50 of that substance as being 1780 mg/kg. This is used to characterise the acute toxicity of HEDTA-H3 and the LD50, re-based according to the molecular weight of the two substances, is therefore taken as being 1303 mg/kg.

 

An inhalation study on the structurally related substance HEDTA-Na3 indicates the LC50 to be in excess of 3.95 mg/L following 4 hours exposure, this being the highest exposure concentration achievable. An acute inhalation toxicity study with EDTA-Na2H2 showed a 6 -h LC30 value of 1000 mg/m3 and was thus more toxic than HEDTA-Na3, probably due to the higher binding capacity of EDTA compared to HEDTA.

 

No relevant data are available on dermal toxicity but the expected low dermal absorption of the substance does not indicate a concern for acute effects.

Justification for classification or non-classification

Taking into account the provisions laid down in CLP (1272/2008/EC), classification as acute oral toxicity category 4 (H302) according to GHS criteria is required.