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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Version / remarks:

24th February 1987

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

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 - 396 108, India
- Weight at study initiation: 202.0 g - 297.0 g
- Housing: individually in polypropylene rat cages
- 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 the application

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

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar area of the trunk
- % coverage: ca. 10 %
- Type of wrap: porous gauze dressing (not more than 8-ply) and a non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed using wet cotton.
- Time after start of exposure: 24 h

TEST MATERIAL
- The test substance was moistened with distilled water.
- For solids, paste formed: no

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 1 hour, 2 hours and 3 hours after the application and thereafter once a day; weighing: prior to the application and after 7 and 14 days.
- 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.

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 by over dose of chloroform and gross pathological examination was carried out. External examination of carcasses did not reveal gross lesion of significance.
In control group, lung showed focal emphysema in two male animals and mild congestion with mottling of liver in one male animal. Whereas, no any internal gross lesions were observed any of the female animal.
In treated group, lung showed mild congestion in three male animals and four female animals. Whereas, liver of one male animal showed mottling and hydrometra in one female animal. In conclusion, the mild gross lesions recorded in lung and liver in animals of control group were taken as incidental. Whereas, in treated group out of ten animals seven animals showed vascular pathology in lung, liver and hydrometra in one female. This clearly points to the mild toxic effect of the test substance with dose induced lesions.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test item to Wistar rat was found to be more than 2000 mg/kg body weight.

Executive summary:

This study was performed to assess the acute dermal toxicity (LD50) of the test item to Wistar rat. The study was conducted in compliance with Good Laboratory Practice following the guidelines of Organisation for Economic Co-operation and Development (OECD) for Testing of Chemicals No. 402 (adopted 24 February 1987) "Acute Dermal Toxicity".

Two groups of rats having 5 males and 5 females per group were randomly selected. One group was kept as control and another group was given a single dose of the test item by dermal application at the dose level of 2000 mg/kg body weight and observed for fourteen days. No mortality was observed in the any group. All the animals that survived at the end of the treatment period were subjected to gross pathological examination. For both the sexes acute dermal median lethal dose (LD50) of the test item to the rat was found to be more than 2 000 mg/kg body weight.