thiacloprid (ISO);(Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide;{(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Jun - 6 Jul 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Version / remarks:

adopted 2017

Deviations:

yes

Remarks:

Some deviations to the current guideline exist: male and females were tested, all animals were tested simultaneously, and it was not stated how many percent of the skin were covered, females exceeded the recommended age.

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 1987

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(2-chlor-5-pyridyl-methyl)-cyanimino-1,3-thiazolidin

EC Number:

601-147-9

Cas Number:

111988-49-9

Molecular formula:

C10H9ClN4S

IUPAC Name:

3-(2-chlor-5-pyridyl-methyl)-cyanimino-1,3-thiazolidin

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Paderborn, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks (males) and 14 - 16 weeks (females)
- Weight at study initiation: 245 - 256 g (males) and 208 - 218 g (females)
- Fasting period before study: not indicated
- Housing: during testing period individually in polycarbonate cages type IIA, during acclimatization in groups in polycarbonate cages type III (<180g five animals >180g max. three animals per cage), both with low-dust wood granules type S 8/15 (Ssniff, Spezialdiäten GmbH, Soest/Westphalia, Germany)
- Historical data: available
- Diet: Altromin® 1324 Diet for Rats and Mice (Altromin GmbH and Co. KG, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
- Microbiological status when known: no pathogens detected

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: 0.9% NaCl solution

Details on dermal exposure:

TEST SITE
- Area of exposure: 3.5 x 4.5 cm (males) and 4.0 x 4.0 cm (females)
- % coverage: not indicated
- Type of wrap if used: The paste of the test substance and 0.9% NaCl solution was formed on a piece of aluminum foil. It was then applied with the foil and fixed in place with an occlusive dressing (fermoflex®).

REMOVAL OF TEST SUBSTANCE
- Washing: soap and water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Constant volume or concentration used: no
- For solids, paste formed: yes

VEHICLE: NaCl solution
- Amount applied : 1.0 mL per g test substance
- Concentration: 0.9%

Duration of exposure:

24 h

Doses:

2000 mg/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: Appearance and behavior was recorded several times on the day of treatment, and at least once a day thereafter. The body weights of the rats were recorded on day 1 before administration and then weekly.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes, appearance, behavior, reactivity, motility, reflexes, gait, paralysis, spasms, tremors etc., respiratory frequency, heart rate, pallor, posture and gastrointestinal functions

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality occurred until the end of the observation period. Please refer to Attachment 1.

Clinical signs:

other: No clinical signs and no local skin reactions were observed.

Gross pathology:

No gross pathologic changes were observed in animals killed at the end of the study period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 for male and female rats was >2000 mg/kg bwt. The test substance caused no systemic toxicity to Wistar rats following acute dermal application. The study is considered valid.