Ziram

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 Feb - 22 Feb 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Version / remarks:

not specified

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

not specified

Deviations:

yes

Remarks:

24 h exposure

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ziram

EC Number:

205-288-3

EC Name:

Ziram

Cas Number:

137-30-4

Molecular formula:

C6H12N2S4Zn

IUPAC Name:

ziram

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A. Smith, Warlingham, Surrey and Froxfield Rabbits, Hampshire, UK
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation: 2.2 - 2.9 kg
- Housing: individually in metal cages with perforated floors
- Diet: Standard laboratory diet (Stanrab P), ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 22
- Humidity (%): 49
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal-lumbar area
- % coverage: equivalent to 10% of the total body surface
- Type of wrap if used: The prepared area was covered with gauze which was held in place with an impermeable dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: The residual test substance was removed at the end of the 24-h exposure period by washing with water and blotting dry with absorbent paper.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no

VEHICLE
No vehicle was used.

Duration of exposure:

24 h

Doses:

2 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and clinical signs soon after dosing and then at frequent intervals for the reminder of Day 1. On subsequent days, the animals were observed at least twice for 14 days. Individual body weights were recorded prior to dosing (Day 1), on Day 8 and the day of necropsy (Day 15).
- Necropsy of survivors performed: On Day 15, all surviving animals were euthanised by an intravenous overdose of pentobarbitone sodium. Gross pathological examinations, including external examination and opening of the abdominal and thoracic cavities, were conducted on all animals in the study. The macroscopic appearance of abnormal organs was recorded.

Statistics:

No statistical analysis was performed.

Results and discussion

Preliminary study:

A trial test was carried out by dosing one male and one femlae rabbit with 2 g/kg bw. The results of the preliminary study indicated that the acute median lethal dermal dose to male and female rabbits of the test substance was greater than 2 g/kg bw.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occured.

Clinical signs:

other: No signs of systemic toxicity were observed in response to treatment.

Body weight:

lower than 10% body weight loss

Remarks:

A loss in body weight was recorded for two females on Day 8. All other rabbits achieved anticipated body weight gains throughout the study.

Gross pathology:

Pale renal cortices were observed in the kidneys of one male at post-mortem. Terminal autopsy revealed no other macroscopic abnormalities.

Other findings:

Dermal responses:
Slight erythema only was observed in two males and two females. The reactions had resolved completely by Day 3 or 4 of the study. The remaining three males and three females showed no response to treatment.

Applicant's summary and conclusion

Interpretation of results:

other: According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, no classification is required.

Conclusions:

The study was performed according to EPA OPP 81-2 (Acute Dermal Toxicity) under GLP conditions. Male and female rabbits of the New Zealand White strain received the test substance at a single dose of 2000 mg/kg bw, moistened with destilled water. Under the conditions chosen, the acute dermal LD50 was determined to be > 2000 mg/kg bw for male and female rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for acute dermal toxicity is required.