Registration Dossier

Administrative data

Endpoint:
neurotoxicity: short-term oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Deviations:
not specified
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: chicken
Strain:
other: Hubbard

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Frequency of treatment:
single exposure
Doses / concentrations
Remarks:
Doses / Concentrations:4000 mg/kg bwBasis:
No. of animals per sex per dose:
6
Control animals:
other: positive and negative control groups
Details on study design:
Type: other: delayed neurotoxicity

Results and discussion

Any other information on results incl. tables

Body weights were significantly reduced in the leptofos group (to 64%) and TOCP group (to 87%) with no effects in the Polygard group. Food intake was significantly higher in the Polygard groups in the second, third and fourth week, while leptofos induced a lower food intake. Animals in the leptofos and TOCP group showed signs of delayed neurotoxicity. Cholinesterase activity was not changed in any of the groups on all days. TOCP and leptofos showed degenerative changes in the axons and myelin sheath in the spinal cord and peripheral nerves. No degenerated axons were found in the control and Polygard group. Histological investigations of the other organs resulted in no effects caused by the different treatments.

Applicant's summary and conclusion

Conclusions:
The authors concluded that it is not plausible that Polygard would result in delayed neurotoxicity in humans, based on the lack of clinical and electronmicroscopical detectable symptoms of delayed neurotoxicity after a single exposure to 4000 mg Polygard/kg bw to chickens.
Executive summary:

Polyguard R (mixture of nonylphenol phosphites) did not produce neurotoxicity in hens.