Registration Dossier
Registration Dossier
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EC number: 245-883-5 | CAS number: 23783-42-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a guideline and GLP OECD422 combined repeat dose and reproductive toxicity study, SD rats were exposed to 3,6,9,12-tetraoxatetradecan-1-ol / 3,6,9,12-tetraoxatetradecan-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, females were receiving 1692 mg/kgbw/day. No reproductive 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 1000 mg/kgbw/day (actual 688 in males, 1249 in females) , the maximum dose used.
A testing proposal has been submitted for and extended one generation reproductive toxicit study using the substance 2 -(2 -(2-methoxyethoxy)ethoxy)ethanol (TEGME) and the results will be read across to this substance using a category approach with the screening study above used as a bridging study to justify such a read across.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 270 mg/kg bw/day
- Species:
- rabbit
Additional information
No developmental toxicity data is available for this substance. Based on observations from other members of the category, and taking into account molecular weight differences, it is possible to estimate the likely NOAELs for the developmental toxicity in both rats and rabbits will exceed 1000mg/kgbw/day.
Justification for classification or non-classification
Based on an assessment of existing data on members of the category, there is no indication of developmental toxicity effects at a dose of 1000mg/kg bw or below or effects that occur below the level where maternal toxicity is also observed. There is no indication that reproductive toxicity is a characteristic of this substance and that classification is warranted for this end point.
Additional information
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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