imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jul - Aug 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:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

adopted 2017

Deviations:

yes

Remarks:

dressing occlusive instead of semi-occlusive

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:

-

EC Number:

428-040-8

EC Name:

-

Cas Number:

138261-41-3

Molecular formula:

C9H10ClN5O2

IUPAC Name:

2-chloro-5-{[2-(nitroimino)imidazolidin-1-yl]methyl}pyridine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder Winkelmann, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: about 9 - 14 weeks
- Weight at study initiation: 207 - 234 g (males), 204 - 214 g (females)
- Fasting period before study: not specified
- Housing: animals were individually housed in type III Makrolon cages equipped with low-dust wood shavings type S 8/15 (Spezialdiaeten GmbH, Soest, Germany) as litter.
- Diet: Altromin 1324 diet for rats and mice (Altromin GmbH & Co KG, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
- Method of randomisation in assigning animals to test and control groups: with the aid of random lists produced with a computer program.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): approximately 50
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: Jul To: Aug 1989

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

TEST SITE
- Area of exposure: 6.0 x 6.0 cm
- Type of wrap if used: occlusive

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

TEST MATERIAL
- Amount(s) applied: 30.5 mg/cm2 (males), 29 mg/cm2 (females)
- Constant volume used: no
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied: 1.5 mL per gram test item

Duration of exposure:

24 h

Doses:

5000 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 were noted several times on the day of study, and then at least once a day. Body weights were recorded before administration, and on the 4th, 8th and 15th study day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross examination

Statistics:

Not reported.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Gross pathological examination revealed no substance-related findings.

Other findings:

The treatment areas did not show grossly apparent alterations.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

The study was performed in accordance to OECD 402 under GLP conditions and is considered reliable. Under the conditions chosen, the acute dermal LD50 was determined to be greater than 5000 mg/kg bw/day for male and female rats. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for acute dermal toxicity is required.