Registration Dossier
Registration Dossier
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EC number: 205-381-9 | CAS number: 139-89-9
Endpoint summary
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.
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