mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt  

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-10-29 to 1997-11-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24th February 1987

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Complexation products of manganese and zinc with ethylenebis(dithiocarbamate)

EC Number:

616-995-5

Cas Number:

8018-01-7

Molecular formula:

(x+y)[C4H6N2S4]2- + xMn2+ + yZn2+, x:y ranges between 1:0.062 to 1:0.12 (mean 1:0.091)

IUPAC Name:

Complexation products of manganese and zinc with ethylenebis(dithiocarbamate)

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding facility, Jai Research Foundation, India
- Weight at study initiation: 93.0 g - 118.0 g
- Fasting period before study: 17 hours prior to dosing
- Housing: Group-housed (5 animals of same sex per cage) in polypropylene rat cage
- Diet: Rat pellet feed (Amrut brand) ad libitum (MF: Nav Maharashtra Chakan Oil Mills Limited, 43, Shaniwar Peth, Pune - 411 030, Maharashtra, India)
- Water: Pure drinking water filtered through Aquaguard water filter system ad libitum
- Acclimation period: 5 days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20 ± 2.0 and 22 ± 1.8
- Humidity (%): 76 ± 6.0
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 mL/kg bw

Doses:

0 and 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Deaths and signs of toxicity were recorded 1, 2 and 3 hours after administration and subsequently once daily for 14 days. Individual body weights were recorded prior to dosing and on day 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in 2000 mg/kg body weight dose group and control group.
The oral LD50 was determined as more than 2000 mg/kg in both sexes.

Clinical signs:

other: No toxicity symptoms were observed in any group.

Gross pathology:

After termination of experiment all animals from control as well as treated group were sacrificed and subjected to thorough gross pathological examination. External examination of carcass did not reveal gross lesions of significance.
In control group, lung showed mild congestion with pinpoint haemorrhages in one female animal and diffused pinpoint haemorrhages in another female animal.
In treated group, lung showed gross pathology such as diffused focal emphysema (1 male animal), mild congestion (1 female animal) and diffused ecchymotic congestion (1 female animal). Whereas, gross pathology in liver showed patchy congestion in one male animal and two female animals. Congested spleen was observed in one male animal and peritoneal adhesion in another male animal was observed in this study
In conclusion, the gross lesion recorded in lung in animal of control group taken as incidental. Whereas, in treated group the vascular pathology in lung and liver showed widespread lesions when compared with control group. Peritoneal adhesion were also recorded in one animal of this group. The severity and incidence of vascular changes in lung, liver, spleen and mesentery in treated group is a result of toxic effect of test substance.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test item was determined to be > 2000 mg/kg bw in rats.

Executive summary:

This study was performed to assess the acute oral toxicity of the test item to Wistar rat . The method followed was as per the guidelines of the Organization for Economic Cooperation and Development (OECD) for testing of chemicals No.401 (adopted 24th February 1987) "Acute Oral Toxicity". Two groups of rats comprising 5 males and 5 females per group were randomly selected. One group was kept as control and another group were subjected to a single oral dose of the test item at the dose level of 2000 mg/kg body weight and observed for 14 days. No mortality was observed in control and 2000 mg/kg body weight dose group. All the animals that survived at the end of the treatment period were subjected to gross pathological examination. The acute oral median lethal dose (LD50) of the test item to the rat was found to be more than 2000 mg/kg body weight.