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Toxicological information

Neurotoxicity

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Description of key information

Key value for chemical safety assessment

Effect on neurotoxicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
25 mg/kg bw/day

Additional information

The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under RegulationEC 1907/2006.

A guideline acute neurotoxicity with ZPT byBarnett (2005)under the U.S. Environmental Protection Agency (1998) Health Effects Test Guidelines; OPPTS 870.6200: Neurotoxicity screening battery, August, 1998.

On the basis of this study, the no-observable-adverse effect-level (NOAEL) of zinc pyrithione following a single dosage via oral gavage is 25 mg/kg. Changes observed at 25 mg/kg in body weights, feed consumption, and in females, motor activity, were minimal and transient. 

A literature search in the open literature has revealed additional studies, which have shown that zinc pyrithione causes this neuropathy in both rats and rabbits. However, the hind limb weakness is reversible. In two studies with rats (Ziller 1977, Snyderet al.1977, following consumption of diet containing 250 ppm zinc pyrithione, animals lost this paralytic effect when returned to control diets.

When the Zinc pyrithione was tested in apes, Funato (1992), no signs of hind limb weakness was observed. Also, in repeated dermal toxicity studies,Ulrich (1993),and inhalation studies, Ulrich (1993), with the rat, no evidence of hind limb weakness was observed with any dose used.


Table 5.16: Summary of neurotoxicity

Method

Results

Remarks

Reference

Oral GavageRat Sprague Dawley.0, 25, 75, & 150 mg/kg

Duration: 15 Days

 

LO(A)EL – 75 mg/kg

NO(A)EL – 25 mg/kg

There were no statistically significant or biologically important differences among the dosage groups for the hindlimb evaluations in the male or female rats.

No test substance-related alterations were noted in the central or peripheral nervous system tissues, eyes with retinas and optic nerves, or skeletal muscle.

 

Reliability – 1

Purpose flag

Study result type

Test material: zinc pyrithione

Barnett (2005)

(unpublished)


Justification for classification or non-classification