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Immunotoxicity

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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.