polymeric zinc propylenebis(dithiocarbamate);propineb (ISO)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010/03/03 to 2010/06/04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) No. 440/2008

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17th December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

polymeric zinc 1,2-propylenebis(dithiocarbamate)

EC Number:

620-365-5

Cas Number:

9016-72-2

IUPAC Name:

polymeric zinc 1,2-propylenebis(dithiocarbamate)

Test material form:

solid

Remarks:

Powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The acclimatization period was at least 5 days. The organisms were given tap water, ad libitum, and the weight at dosing was 323-363 g males and 201-226 g females.

The animals were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and three rats of the same sex and group during the treatment period. Each cage contained autoclaved sawdust.

The environmental conditions for temperature was 22 ± 2°C, humidity (30 to 70%), air changes (per hr): Approximately 12 and photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: 12 to 31 March 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other:

Remarks:

0.5% (w/v) Methylcellulose/0.4% (w/v) Tween 80 in purified water.

Details on oral exposure:

The test item was administered once, using a metal gavage tube fitted to a 5 mL plastic syringe (0.2 mL graduations). The quantity of the test item administered to each animal was adjusted according to the body weight recorded on the day of dosing.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5, 50, 300 or 2000 mg/kg body weight.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Three males and three females were used for each step. The dose-level to be used as the starting dose-level was selected from one of four fixed levels, 5, 50, 300 or 2000 mg/kg body weight. The dose-level have been selected in agreement with the Sponsor, based on the results of a previous non GLP study, in which the acute oral LD50 of the test item was higher than 2000 mg/kg.

Therefore, the test item was administered to 3 males and 3 females at the dose-level of 2000 mg/kg then in agreement with the Sponsor, the dose-level was carried out on 3 males and 3 females to confirm the results.

Statistics:

The data did not warrant statistical analysis.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

The dose of 2000 mg/kg bw induced no mortality.

Clinical signs:

other: other: No clinical signs were observed.

Gross pathology:

No abnormalities were observed at gross necropsy.

Any other information on results incl. tables

Table one

Doses, mortality /clinical signs/ animals treated

Dose (mg/kg bw)	Toxicological results*		Occurrence of signs	Mortality (%)
2 000 (1^st)	Males 0/0/3	Females 0/0/3	-	0
2 000 (2^nd)	Males 0/0/3	Females 0/0/3	-	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The objective of this study was to evaluate the toxicity of the test item, Propineb, following a single oral administration in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The test item was administered by oral route (gavage) to 2 groups of six fasted Sprague-Dawley rats (three males and three females) at the dose-level of 2000 mg/kg under a dosage-volume of 10 mL/kg. The acute oral LD50 cut-off of propineb in the rat was found to be 5000 mg/kg bw, the oral LD50 of the test item Propineb was higher than 2000 mg/kg in rats.

Executive summary:

The objective of this study was to evaluate the toxicity of the test item, Propineb, following a single oral administration in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

 

The test item was administered by oral route (gavage) to 2 groups of six fasted Sprague-Dawley rats (three males and three females) at the dose-level of 2000 mg/kg under a dosage-volume of 10 mL/kg. The test item was prepared in 0.5% (w/v) Methylcellulose/0.4% (w/v) Tween 80 in purified water.

Mortality, clinical signs and body weight gain were checked for a period of up to 14 days following the single administration of the test item. On completion of the observation period, the animals were sacrificed then subjected to a macroscopic post-mortem examination. The interpretation of results was based on the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).

Neither mortality nor clinical signs observed during the study. Lower body weight gain was noted during the first week in 1/3 females of the first assay and in 2/3 females of the confirmatory assay. The body weight gain of the other animals was not considered to be affected by treatment with the test item. At necropsy, no apparent abnormalities were observed in any animal.

 

Under the experimental conditions of this study, the oral LD50 of the test item, Propineb, was higher than 2000 mg/kg in rats. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by oral route, the test item should not be classified.