Registration Dossier

Administrative data

Description of key information

Immunotoxicity of the registered substance has not been specifically investigated however, in a fully compliant 90-day toxicity study inclusive of a satellite OECD 421 study no changes in absolute and relative weights of thymus and spleen in main study animals, as well as no change in thymus weight of satellite females were recorded. Haematology revealed an increase, not a decrease in total leukocyte and lymphocyte counts in top dose males. Histopathological examination of thymus, spleen and lymph nodes of main animals, and of thymus of satellite females also revealed no abnormalities. Histopathological examination of lymph nodes, thymic region and spleen in a 28-day inhalation study aslo did not reveal any changes.

Immunotoxicity is considered of no concern for the registered substance.

Key value for chemical safety assessment

Effect on immunotoxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
521 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
high quality of dataset

Effect on immunotoxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
21.53 mg/m³
Study duration:
subacute
Species:
rat

Effect on immunotoxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No specific data on immunotoxicity are available for the test material however, in a fully compliant subchronic 90-day dietary toxicity study, as well as in a satellite OECD 421 study in rats, no changes in the weights of organs and tissues relevant to the immune system were detected. In addition, microscopic examination of thymus, spleen and lymph nodes performed in the above-mentioned subchronic dietary study and in a subacute 28-day inhalation study did not reveal any changes in these organs. On these bases immunotoxicity is considered of no concern for the test material.

Justification for classification or non-classification