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EC number: 205-759-3 | CAS number: 150-39-0
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 reliable data available.
Table 1: Mortalities of rats after oral application of Na4EDTA
Table 2. Duration of signs, test group 1, main group (1.963 mg/L).
Fur, substance contaminated
d0 – d1
h3 – h4
d0 – d2
Table 3. Duration of signs, test group 2 (10.054 mg/L).
d0 – d4
Nose, red encrusted
h1 – h4
d0 – d6
Table 4. Duration of signs, test group 1, satellite group (exposed for 4 hours at 1.963 mg/L and killed after 24 hours)
Table 5. Particle size analysis
Geometrical Standard Deviation
MMAD - mass median aerodynamic diameter) is the calculated aerodynamic diameter which divides the size distribution in half when measured by mass
Table 6. Group 1 Satellite (5) Males, summary of larynx histopathology.
1 (1.963 mg/L)
· Grade 1
· Grade 3
· Grade 4
Infiltration, inflammatory cells
· Grade 1
· Grade 2
· Grade 3
· Grade 3
· Grade 4
The acute inhalation toxicity (single 4 -hour exposure) of Masquol EDTA OH has been investigated in the rat according to OECD, EU and US EPA test guidelines and using an aerosol generated from the liquid formulation.
The following measured concentrations were tested:
0 (control), 1.963 mg/L and 10.054 mg/L expressed as the supplied formulation
0 (control), 1.003 mg/L and 5.138 mg/L expressed as the non-volatile fraction of the supplied formulation (51.1%)
0 (control), 0.77 mg/L and 3.95 mg/L expressed as the active substance content of the supplied formulation (39.3% HEDTA)
The higest concentration investigated was the maximum technically attainable with the test system and particle size distributions (MMAD) was between 0.6 and 2.0 μm, within the respirable range.
No lethality was observed in male and female animals in both concentrations during the study period of 14 days and the LC50 is therefore in excess of the maximum concentration achievable, 10.054 mg/L supplied formulation / 3.95 mg/L HEDTA.
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 reliable data are available on dermal toxicity but the expected low dermal absorption of the substance does not indicate a concern for acute effects.
Taking into account the provisions laid down in CLP (1272/2008/EC), classification as acute toxicity category 4 (H302) according to GHS criteria is required.
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