Registration Dossier
Registration Dossier
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EC number: 245-883-5 | CAS number: 23783-42-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
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 adverse effect observed
Additional information
No repeat dose toxicity information by the inhalation route is available. Because of the very low volatility of this substance and the low toxicity demonstrated by other routes, it can be concluded that toxicity by the inhalation route is not of concern.
In a guideline and GLP OECD422 combined repeat dose and reproductive toxicity study, male and female SD rats were exposed to 3,6,9,12 -tetraoxotridecan-1 -ol (TetraEGME) by drinking water for 36 days for males and 53 -65 days for females. The average actual doses received by males were 70, 222 and 688 mg/kgbw/day and by females 126, 393 and 1249 mg/kgbw/day. During the post partum/lactation phase, high dose females were receiving 1692 mg/kgbw/day. No effects were seen in any dose group and for either sex that were deemed to be adverse and attributable to treatment. The NOAEL in the study was determined to be the nominal limit dose of 1000 mg/kgbw/day, the maximum dose tested.
There is no sub-chronic toxicity study however, but, ased on observations from other members of this category, it can be concluded that the data from TEGME is a good conservative surrogate to predict the sub-chronic toxicity of this substance and that it will have low repeat dose toxicity by all routes of exposure. NOAELs can be predicted from TEGME after taking into account molecular weight differences. This is conservative and supported by the 422 as a bridging study which showed no effects up to a limit dose of 1000 mg/kgbw/day (which was an actual dose of 688 mg/kgbw/day for 36 days in males and 1249 mg/kgbw/day for 53 -65 days in females)
Justification for classification or non-classification
No adverse effects are seen below the thresholds for classification.
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