Registration Dossier

Administrative data

Description of key information

Acute oral toxicity - Weight of evidence suggests the median lethal dose to be close to 2000 mg/kg. Due to the limited data available for the substance itself, a well documented study on the analogue tetrasodium EDTA describes the LD50 of that substance as being 1780 mg/kg. This is used to determine the acute toxicity of this substance and the LD50, recalculated based on the molecular weight of the two substances, is therefore taken as 1612 mg/kg (see also read across document in section 13).

Acute inhalation toxicity - The LC50(4h) is in excess of 3.95 mg/L, the highest exposure concentration technically achievable.

Acute dermal toxicity - No reliable data available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 612 mg/kg bw
Quality of whole database:
A number of studies is available regarding acute oral toxicity providing aweight 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 being 1780 mg/kg. This is used to determine the acute oral toxicity of this substance and the LD50, recalculated based on to the molecular weight of the two substances, is therefore 1612 mg/kg.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
3 950 mg/m³
Quality of whole database:
Single study available on the substance itself, 4-h LC50 > 3950 mg/m3

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 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 1780 mg/kg. This is used to determined the acute toxicity of Na3-HEDTA and the LD50, recalculated based on the molecular weight of the two substances, is therefore 1612 mg/kg.

 

An inhalation study indicates the LC50 of HEDTA-Na3 to be in excess of 3.95 mg/L following 4 hours exposure, this being the highest exposure concentration technically achievable.

 

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

Justification for classification or non-classification

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