clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 Sep - 04 Oct 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

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:

housing conditions slightly divergent, 6 animals were used, body weights only noted at the start of study, no anaesthetics used

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-460-1

EC Name:

-

Cas Number:

210880-92-5

Molecular formula:

C6H8ClN5O2S

IUPAC Name:

(E)-N'-[(2-chloro-1,3-thiazol-5-yl)methyl]-N-methyl-N''-nitroguanidine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd, Margate, UK
- Age at study initiation: 11 - 14 weeks
- Weight at study initiation: 2.10 - 2.47 kg
- Housing: individually in floor-pens with a minimum floor area of 0.6 m²
- Diet: pelleted SQC TRB Rabbit Diet 9603 (Harlan Teklad, Bicester, UK), ad libitum
- Water: mains water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 40 - 80
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 10/14

IN-LIFE DATES: From: 10 Sep 1996 To: 04 Oct 1996

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 66 mg (the weight equivalent to 0.1 mL)

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

Observation period: 72 h
Reading time points: 0.5, 1, 4, 24, 48 and 72 h.

Number of animals or in vitro replicates:

1 male (step 1) and 5 males (step 2)

Details on study design:

TREATMENT OF THE ANIMALS
One dose consisting of 66 mg (the weight equivalent to 0.1 mL) in powder form was instilled into the left conjunctival sac of the rabbit (step 1). The lower eyelid was gently prised away from the eyeball to create a receptacle for the dose. After instillation the eyelids were held closed for a few seconds to prevent loss of the dose. The right eye remained untreated and served as a control to the treated eye. After observing the (lack of) effect on the treated eye, 5 additional male rabbits were treated.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Fluorescein at the 24-h reading time point

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Mild conjunctivae (score 1) was noted in 6/6 animals during the 1-h reading time point. All conjunctival irritation reactions resolved within 24 h of treatment and were not observed thereafter. The cornea and iris were unaffected by the test substance.

Other effects:

No observations indicative of systemic toxicity or ill health were noted for any
rabbits during the course of the study.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 12 72/2008.

Conclusions:

The study is in accordance with 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 irritancy is required.