Registration Dossier
Registration Dossier
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EC number: 939-996-5 | CAS number: 689294-28-8
Endpoint summary
Administrative data
Description of key information
No acute oral toxicity is expected.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are no experimental nor literature toxicological data available on TATD-CLE. Therefore the read across approach was considered in order to trace a complete toxicological profile of the substance.
RA Cefalonium (EC: 226-948-7; CAS: 5575-21-3)[1]:
- Acute toxicity of cefalonium was low. The oral LD50 values in male and female mice were greater than 12000 mg/kg and greater than 5000 mg/kg bw in both sexes of rats. At necropsy almost no intestinal contents were found orally and subcutaneously trated fatal cases [...].[1]
RA Cefuroxime (EC: 259-560-1; CAS: 55268-75-2):
- LD50 oral mouse > 10 g/kg. Effects: Behavioural: ataxia. Sense organs and special senses, ptosis, eye[2].
- LD50 oral rat: 10 g/kg[2]
- LD50 oral mouse > 20 g/kg. Effects: Behavioural: somnolence (general depressed activity)[3].
- LD50 oral rat > 20 g/kg. Effects: Behavioural: convulsions or effect on seizure threshold. Sense organs and special senses. Other: eye. Lungs, thorax, or respiration dyspnea[3].
All available data on the structural analogues are far above the CLP classification threshold for the acute oral toxicity endpoint; therefore there are no reasons of concern about this endpoint for TADT-CLE.
No data for both dermal and inhalation route are available.
Reference
[1] EMEA, Committee for veterinary medicinal products. Cefalonium. Summary report. EMEA/MRL/646/99-Final.August 1999.
[2] Secondary source: U.S. National Library of Medicine; Reference:Chemotherapy Vol. 27(Suppl).
[3] Secondary source: U.S. National Library of Medicine; Reference:Chemotherapy Vol. 31(Suppl).
Justification for classification or non-classification
According to CLP regulation (EC1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 available values are all above the 2000 mg/kg body weight, that is the threshold indicated in the CLP regulation for the classification as oral acute toxicant.
No information about both dermal and inhalation acute toxicity are available.
In conclusion, TADT-CLE is not classified for the oral/inhalation/dermal acute toxicity, according to CLP regulation (EC1272/2008).
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