Registration Dossier
Registration Dossier
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EC number: 205-187-4 | CAS number: 135-37-5
Endpoint summary
Administrative data
Description of key information
The acute median lethal oral dose of EDG (acid) in male and female rats was determined to be 1600 (95% confidence limits: 1400-2000) mg/kg bw.
A study with EDG-Na2 showed mortality in 1/3 rats treated at 2000 mg/kg bw. Although this could lead to the conclusion that the LD50 would be >2000 mg/kg bw, however, a possible second mortality in this group would have resulted in an LD50 value < 2000 mg/kg bw.
The acute percutaneous toxicity (LD50) of EDG Na salt was >2 mL/kg bw when administered as a 40% w/v slurry to New Zealand White rabbits; thus the dermal LD50 value was in excess of 800 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 600 mg/kg bw
- Quality of whole database:
- Results supported by a second study with the acid; a supporting study with EDG-Na2 showed mortality in 1/3 animals treated at 2000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Study with limitations; a low number of animals, and use of abraded skin.
Additional information
The acute oral and dermal toxicity study results with EDG-Na2 were confirmed by the results with the structurally related analogue NTA-Na3 (see also read across document in section 13). With regard to NTA-Na3, acute inhalation toxicity seems to be low as exposure close to the maximum technically attainable concentration (5 mg/L) for 4 h did not cause any deaths.
Justification for classification or non-classification
Because the oral LD50 value was between 300 and 2000 mg/kg bw, EDG-Na2 needs classification as acute oral toxic GHS cat. 4. The dermal LD50 was in excess of 800 mg/kg bw; as no mortality was seen at this level and clinical signs were minimal, no classification is needed for acute dermal toxicity.
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