Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 290-649-8 | CAS number: 90194-39-1
Immunotoxicity
Administrative data
Description of key information
In rats a NOAEL of 25 mg/kg bw/d was
reported. No significant decrease in reticulocyte number was observed at
this dose level. The decrease observed in doses greater than 25 mg/kg bw/d
suggest that DEA has a deleterious effect on erythropoiesis.
A LOAEL of 100 mg/kg bw/d was reported for mice based on decreased
cytotoxic T lymphocyte (CTL) activity and an increase in tumour burden
following challenge with the B16F10 melanoma tumour.
The data do not indicate that these effects are more critical compared
to other reported systemic effects (see section on repeated dose
toxicity). Therefore, the long-term DNELs are also considered sufficient
to prevent immunotoxic effects of DEA.
Key value for chemical safety assessment
Effect on immunotoxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Publication; test procedure in accordance with national standards with acceptable restrictions.
Effect on immunotoxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Effect on immunotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No experimental data on immunotoxicity is available for the test item. However, experimental data for source substance 3 (CAS 111 -42 -2) is available and a read-across approach is applied. Please refer to read-across justification document attached in IUCLID Section 13. Furthermore, only key studies of the source substance are taken into account. For further supporting information please refer to respective dossier of the source substance.
Female Fischer 344 rats were administered DEA daily for 14 days at doses of 50, 100 and 200 mg/kg bw (Munson et al, 1992b). DEA was administered by gavage as a solution in sterile distilled water. A no effect level could not be established, since a significant decrease in reticulocyte number was observed at all dose levels. However, based on the results from the range finding study, the no effect level was determined to be 25 mg/kg bw. No significant decrease in reticulocyte number was observed at this dose level. The decrease observed in doses greater than 25 mg/kg bw suggest that DEA has a deleterious effect on erythropoiesis.
Female B6C3F1 mice were administered DEA daily for 14 days at doses of 100, 300 and 600 mg/kg bw (Munson et al, 1992a). DEA was administered by gavage as a solution in sterile distilled water. A no-effect level for DEA in the female B6C3F1 mouse could not be established since the lowest dose administered significantly decreased the cytotoxic T lymphocyte (CTL) activity, and produced an increase in tumour burden following challenge with the B16F10 melanoma tumour.
The available data show that DEA may cause immunotoxic effect. The data do not indicate that these effects are more critical compared to other reported systemic effects (see section on repeated dose toxicity). Therefore, the long-term DNELs are also considered sufficient to prevent immunotoxic effects of DEA.
Justification for classification or non-classification
See section on repeated dose toxicity.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
