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Administrative data

Description of key information

No data on acute toxicity of zinc bis(dibenzyldithiocarbamate) (ZBEC) were available for assessment. However, based on the data from the structural analogue zinc bis(dibutyldithiocarbamate) (ZDBC), the acute toxicity of zinc bis(dibenzyldithiocarbamate) via oral and dermal routes of exposure is considered to be low, with LD50 > 2000 mg/kg bw/day. No data on inhalation route of exposure are available; however, the performance of a study is not warranted in accordance with Column 2 of REACH Annex X, as the data on two other routes of exposure are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please see for more information the read-across justification in Section 13.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please see for more information the read-across justification in Section 13.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

No data on acute toxicity of zinc bis(dibenzyldithiocarbamate) (ZBEC) were available for the assessment. However, Article 13 of the REACH legislation states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across.

Several acute oral toxicity studies with a structural analogue zinc bis(dibutyldithiocarbamate) (ZDBC) were available for assessment, all reporting LD50 values well above 2000 mg/kg bw. Out of these studies, the most recent one (Monsanto Company, 1982), performed under GLP, was chosen as a key study. Five Sprague-Dawley rats of each sex were administered a single oral dose of 5000 mg/kg bw of the test substance as a 434 mg/ml suspension in corn oil. No mortalities occurred and no abnormal findings were noted at necropsy. Diarrhea occurred in three males and five female rats on the day of dosing, but this effect was probably induced by the corn oil used as the dosing vehicle.

Two acute dermal toxicity studies with rabbits using the same test substance were available for assessment, one with very limited reporting. Respectively, the other one, more recent GLP-compliant study (Monsanto, 1982) was chosen as a key study. The test material moistured with physiological saline was administered to abraded skin of a dorsal surface of five New Zealand White rabbits of each sex in the amount of 2000 mg/kg bw under occlusive conditions. After 24 hours the patch was removed, the excessive test material wiped off, and the animals were observed for 14 days and necropsied afterwards. There were no mortalities. Erytherna was observed in the exposed area of three male animals and one female rabbit on the first day after exposure. No other clinical abnormalities were noted. At necropsy, pale renal coloration was observed in one male animal, but this was not considered to be related to exposure to the test material. No abnormalities were observed in the remaining nine rabbits.

Overall, based on the data from the structural analogue zinc bis(dibutyldithiocarbamate) (ZDBC), acute toxicity of zinc bis(dibenzyldithiocarbamate) (ZBEC) is considered to be low as well, with LD50 values for dermal and oral toxicity in rats above the cut-off limit of 2000 mg/kg bw. No data on inhalatory route of exposure were available for assessment. However, the performance of the study is not warranted in accordance with Column 2 of REACH Annex VIII, as data on acute toxicity by other two routes of exposure are available.

Justification for classification or non-classification

Based on the data from the structural analogue zinc bis(dibutyldithiocarbamate) (ZDBC), for which LD50 values in rats of > 5000 mg/kg bw and > 2000 mg/kg bw were reported for acute oral and acute dermal toxicity, respectively, classification of zinc bis(dibenzyldithiocarbamate) (ZBEC) for acute toxicity is not warranted in accordance with Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.