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

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 2020

Deviations:

yes

Remarks:

diet not provided ad libitum, no anaesthetics used, observation period only 7 days

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: not reported, adult animals
- Weight at study initiation: 3.1 - 3.3 kg
- Housing: individual in wire type III upright cages
- Diet: standard diet "ssniff K4" (Versuchstierdiäten GmbH, Soest, Germany), approximately 120 g per animal and day
- Water: tap water, ad libitum
- Acclimation period: at least 14 days in the 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

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL, equivalent of approximately 60 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: physiological saline solution
- Time after start of exposure: 24h

SCORING SYSTEM: DRAIZE criteria as stated in OECD TG 405

TOOL USED TO ASSESS SCORE: optical instruments and one drop of a 1% fluorescein solution

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

At the 1h time point one animal was scored for conjunctivae redness grade 2 and chemosis grade 1 and another animal was scored for conjunctivae redness grade 1. All findings were reversible within 24 h. No further effects were noticed.

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