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EC number: 616-995-5 | CAS number: 8018-01-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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.
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