Evaluation of the Teratogenicity of Ethylenediamine Dihydrochloride in Fischer 344 Rats by Conventional and Pair-Feeding Studies

DEPASS, LINVAL R.; Yang, Raymond S. H.; WOODSIDE, MURRAY D.

doi:10.1093/toxsci/9.4.687

Cited by 4 publications

(5 citation statements)

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“…In a non‐GLP developmental toxicity study, EDA·2HCl was fed to Fischer 344 rats on gestation days (GD) 6 through 15 at levels of 0, 50, 250 and 1,000 mg/kg bw per day (equivalent to 0, 23, 113 and 452 EDA mg/kg bw per day) (DePass et al., 1987). 36 Twenty animals per each treatment group were used and 40 served as control timed‐pregnant.…”

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of manganese chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)

Additives¹,

Bampidis²,

Azimonti³

et al. 2021

EFS2

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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese chelate of ethylenediamine (Manganese-EDA-Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of manganese mono-chelate of EDA, but of several coexisting (manganese) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive. The FEEDAP Panel could not evaluate the safety for target species, consumer and environment and the efficacy of the additive owing to the uncertainties and limitations identified in the studies submitted. Concerning the safety of the additive for the users, the Panel considered that handling the additive poses a risk to users by inhalation. The additive should be considered as corrosive to eyes and a skin sensitiser.

show abstract

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of manganese chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)

Additives¹,

Bampidis²,

Azimonti³

et al. 2021

EFS2

View full text Add to dashboard Cite

show abstract

“…In a non‐GLP developmental toxicity study, EDA·2HCl was fed to Fischer 344 rats on gestation days (GD) 6 through 15 at levels of 0, 50, 250 and 1,000 mg/kg bw per day (equivalent to 0, 23, 113 and 452 EDA mg/kg bw per day) (DePass et al., 1987). 35 Twenty animals per each treatment group were used and 40 served as control timed‐pregnant.…”

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of zinc chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2021

EFS2

View full text Add to dashboard Cite

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of zinc chelate of ethylenediamine (Zinc‐EDA‐Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of zinc mono‐chelate of EDA, but of several coexisting (zinc) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive. The FEEDAP Panel could not evaluate the safety for target species, consumer and environment and the efficacy of the additive owing to the uncertainties and limitations identified in the studies submitted. Concerning the safety of the additive for the users, the Panel considered that handling the additive poses a risk to users by inhalation. The additive should be considered as corrosive to eyes and a skin sensitiser.

show abstract

“…In a non‐GLP developmental toxicity study EDA·2HCl was fed to Fischer 344 rats on gestation days (GD) 6 through 15 at levels of 0, 50, 250 and 1,000 EDA·2HCl mg/kg bw per day (equivalent to 0, 23, 113 and 452 EDA mg/kg bw per day) (DePass et al., 1987). 38 Twenty animals per each treatment group were used and 40 served as control timed pregnant.…”

Section: Assessmentmentioning

confidence: 99%

“…The authors of the study concluded that EDAÁ2HCl is not teratogenic in Fischer 344 rats. (DePass et al, 1987).…”

Section: Studymentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of iron chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2021

EFS2

View full text Add to dashboard Cite

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of iron chelate of ethylenediamine (Iron-EDA-Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of iron monochelate of EDA, but of several coexisting (iron) species; therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation. The FEEDAP Panel concludes that the additive is safe for poultry for fattening and reared for laying/breeding, but cannot conclude on the safety for other animal species/categories. The FEEDAP Panel cannot conclude on the safety of the additive for the consumer or the environment. The FEEDAP Panel concludes that handling the additive poses a risk to users by inhalation. The additive should be considered as non-irritant for the skin but irritant for the eyes and skin sensitiser. The FEEDAP Panel cannot conclude on the efficacy of the additive.

show abstract

Evaluation of the Teratogenicity of Ethylenediamine Dihydrochloride in Fischer 344 Rats by Conventional and Pair-Feeding Studies

Cited by 4 publications

References 0 publications

Safety and efficacy of a feed additive consisting of manganese chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)

Safety and efficacy of a feed additive consisting of manganese chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)

Safety and efficacy of a feed additive consisting of zinc chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)

Safety and efficacy of a feed additive consisting of iron chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.)

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