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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 - 12 May 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 2015

Deviations:

yes

Remarks:

age of animals at study initiation not reported, one test with 3 animals performed instead of initial + confirmatory test, observation period 7 instead of 14 days

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1981

Deviations:

no

GLP compliance:

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 material form:

solid: crystalline

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: not reported, adult animals
- Weight at study initiation: 2.8 - 3.4 kg
- Housing: individually in wire type III upright cages
- Diet: ssniff K4 standard diet (Versuchstierdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 2 weeks in quarantine station

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): approx. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 05 May 1987 To: 12 May 1987

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Hansamed "Hypoallergen" dressing (Beiersdorf No. 2342) fastened with elastic adhesive tape (Fixomull Stretch Klebevlies, Beiersdorf No. 2039)

REMOVAL OF TEST SUBSTANCE
- Washing: exposed skin area was cleaned with water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48, 72h and 7d

SCORING SYSTEM:
- Method of calculation: Draize scoring system described in OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

One animal was scored for erythema and escharosis formation grade 1 (slight, barely perceptible redness) at the 1h time point. The finding was reversible within 24h. No further effects were seen.

Other effects:

None.

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 is in accordance to OECD TG 404, was conducted under GLP and is considered valid and reliable. Under the conditions chosen the test substance did not induce skin irritation to rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for skin irritation is required.