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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Value:
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.
Value:
3 950 mg/m³ air
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.