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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

No specific adverse effects on the immune system have been observed in animal studies or in exposed workers.

Key value for chemical safety assessment

Effect on immunotoxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Effect on immunotoxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Effect on immunotoxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

The summary below was taken from the Renewal Assessment Report prepared according to the Commission Regulation (EU) N° 1107/2009 of Mancozeb (Volume 1):


Testing for immunotoxicity is not a standard requirement in Regulation EC 283/2013; however there is a need to report all potentially adverse effects found during routine toxicological investigations (including effects on organs and special systems such as the immune system). There are concerns about the potential immunotoxicity of mancozeb as a result of evidence that its major metabolite, ETU, caused effects on the thymus (reduced weight and atrophy of lymphoid tissue in adults at 10 mg/kg bw/d and reduced weight at 2 and 10 mg/kg bw/d) in an extended one generation study in the rat (Marty et al., 2013b). However, no immunotoxicity was observed in a specific 28-day dietary immunotoxicity study in rats up to a dose (19 mg/kg bw/d) causing generalised and thyroid toxicity (Buesen et al., 2012b). Thymic involution was seen in both sexes in a 13-week study in dogs (Briffaux, 1991 - summarised in section B.6.8.1.1) at the top dose of 2000 ppm (approx. 66 mg/kg bw/d). However, this occurred in the presence of severe toxicity, including deaths and is therefore considered the unspecific secondary consequence of the marked toxicity observed at this dose.


In acute, short term and subchronic studies with mancozeb in rodents there is no evidence of effects on thymus, spleen, lymphoid tissue or haematological parameters. An increase in relative weight was seen in females only at the top dose of 75 mg/kg bw/d in a 3-month dietary study in rats (Goldman, 1986 – see section B.6.3.2). However, this was not associated with histopathology; was not seen in males and was not reproduced in other rat studies of longer duration. It is possible this observation was a chance finding un-related to treatment. In a three month dietary study with mancozeb in dogs (Cox, 1986 – see section B.6.3.2) a decrease in thymus size was noted at the 1000 (approx. 30 mg/kg bw/d) and 5000 ppm (approx. 100 mg/kg bw/d) concentration levels and thymic cortical lymphoid depletion was seen microscopically in both sexes at these dose levels. However, it was concluded that many effects including those on the thymus were probably secondary to the generalised systemic toxicity and other system/organ toxicity of mancozeb seen at these dose levels. It also noted that effects on the thymus were not reproduced in other dog studies at similar or higher dose levels and for longer durations of treatment (up to 1 year). In addition, they were not seen in the rat, the species of choice for immunotoxicity testing.


Human data on this endpoint are available from the open literature. Overall, there is no convincing evidence in experimental animals and in exposed workers that mancozeb has specific adverse effects on the immune system.

Justification for classification or non-classification

As stated in the Renewal Assessment Report prepared according to the Commission Regulation (EU) N° 1107/2009 of Mancozeb (Volume 1), there is no convincing evidence in experimental animals and in exposed workers that the substance has specific adverse effects on the immune system. Therefore the substance is not considered to be classified for immunotoxicity.