Registration Dossier
Registration Dossier
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EC number: 203-797-5 | CAS number: 110-73-6
Endpoint summary
Administrative data
Description of key information
Non-standard 30-day and 90-day drinking water studies are available for the substance in addition to a screening study using a read-across substance; a testing proposal for a 90-day study is included.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 40 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Non-standard 30-day and 90-day drinking water studies are available for the substance in addition to a screening study using a read-across subtsance; a testing proposal for a 90-day study is included.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Short-term administration of neutralized EAE in the drinking water produced evidence of pronounced cumulative toxicity. The 30-day LC50 was 1412 ±710 ppm. At lower concentrations given over a period of 90 days the main toxic effects of EAE were retardation of growth and degenerative changes in the liver and kidneys. A concentration of 25 ppm EAE in the drinking water for 90 days resulted in minor changes and was considered to be close to the no-effect level. The no adverse effect level was effectively the low dose group, receiving 250 ppm. For rats of circa 300-350 g, having a total cumulative dose of 355 mg over a period of 30 days (the total weight of substance consumed on average per rats over the treatment period), the estimated dose expressed in mg test substance per kg bodyweight per day was 40 mg/kg bw/day for the low dose group. This was the effective NOAEL. An OECD 422 screening study performed using the read-across substance methylaminoethanol identifies a LOAEL of 50 mg/kg bw/d based on renal effects (tubular degeneration) in male rats.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
A weight of evidence approach is used for this endpoint; the 30-day study identifies a lower NOAEL.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; urogenital: kidneys
Justification for classification or non-classification
The available data do not indicate classification for STOT-RE according to the CLP Regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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