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

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating

Eye irritation (OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Apr - 09 May 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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, effect on body weight / general condition not reported

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, UK
- Age at study initiation: not specified; adult animals
- Weight at study initiation: 3.5 - 4.6 kg
- Housing: individually in stainless steel cages with flat rod bases or plastic cages with perforated bases
- Diet: 100 - 120 g per animal/day standard diet "Ssniff K4" (Ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water, ad libitum
- Acclimation period: about 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 50 - 70
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 25 Apr 1995 To: 09 May 1995

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg test substance moistened with water

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 PV3) fastened with semiocclusive elastic adhesive tape (Fixomull Stretch Klebevlies, Beiersdorf No. 2293)

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 and 72 h and 7 days

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

E16

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

B12

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

E17

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Very slight erythema (grade 1) were noted for all three animals 1 h after exposure. This effect was unchanged at later time points and full reversibility observed within 48 h (1/3 animals) or 72 h (2/3 animals). No effect on edema was observed in all three animals.

Other effects:

No further effects were reported.

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 with 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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Apr - 09 May 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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, no sequential testing, effect on general condition and body weight not reported

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 1987

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, UK
- Age at study initiation: not specified; adult animals
- Weight at study initiation: 3.5 - 4.6 kg
- Housing: individually in stainless steel cages with flat rod bases or plastic cages with perforated bases
- Diet: 100 - 120 g per animal/day standard diet "Ssniff K4" (Ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water, ad libitum
- Acclimation period: about 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 50 - 70
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 25 Apr 1995 To: 09 May 1995

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 µL (approx. 50 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: the treated eye was rinsed with normal saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: with the aid of a hand-slit lamp and one drop of a 1% fluorescein solution

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

B19

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

D2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

D1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

B19

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

D2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

D1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Chemosis: At the 1h time point, 2/3 animals were scored grade 1 and 1/3 animals was scored grade 2 for chemosis. This effect was fully reversible within 24 h (1 animal scored grade 1 at 1 h) or 48 h (1 animal scored grade 2 and 1 animal scored grade 1 at 1 h), respectively. Conjunctivae redness: 1 h after administration, all three animals were scored grade 1 for conjunctivae redness. This effect was fully reversible within 24 h (1/3 animals) or 48 h (2/3 animals), respectively. No effects on iris and cornea opacity were noted in any animal.

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 with OECD TG 405, was conducted under GLP and is considered valid and reliable. Under the conditions chosen the test substance did induce irritation to the eye (conjunctivae and chemosis score) of 2/3 rabbits at the 24h reading time point, but the observed effects were fully reversible within 48 h. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for eye irritation is required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

The irritancy potential of the test substance to skin was evaluated according to OECD guideline 404 and in compliance with GLP (M-000708-03-1). In this study, 0.5 g test substance (purity 97.3%) was applied to the shaved skin of the left or right flank each of 3 New Zealand White rabbits under a semi-occlusive dressing for 4 h. A with water moistened patch was placed on the opposite flank for control. After exposure ended the skin was washed with water and scored for erythema and edema at reading time points 1, 24, 48 and 72 h and 7 days after removal of the dressing. The test item induced very slight erythema (grade 1) that were noted for all three animals 1 h after exposure. This effect was unchanged at later time points and full reversibility observed within 48 h (1/3 animals) or 72 h (2/3 animals). No effect on edema was observed in all three animals. Thus, the mean erythema score (24/48/72 h) was 0.7 in 2/3 rabbits with effects being fully reversible within 72 h, and the same score was 0.3 in 1/3 rabbits with effects being fully reversible within 48 h. The mean edema score (24/48/72 h) was 0 for all three animals tested. No other cutaneous reactions were observed until the end of the study. In conclusion, the test substance did not exhibit skin-irritating properties in the conducted study.

 

Eye irritation

A GLP-conform eye irritation/corrosion study was performed according to OECD guideline 405 to evaluate the eye irritancy potential of the test substance (M-000708-03-1). A single dose of 0.1 mL (equivalent to approx. 50 mg) test substance (97.3% purity) was instilled to the eye of each of three New Zealand White rabbits. After 24 h of exposure, the test substance was washed off the eyes with physiological saline solution.The test item induced slight chemosis at the 1 h reading time point in 2/3 animals (grade 1) and mild chemosis in 1/3 animals (grade 2), respectively. This effect was fully reversible within 24 h (1 animal scored grade 1 at 1 h) or 48 h (1 animal scored grade 2 and 1 animal scored grade 1 at 1 h), respectively. Furthermore, conjunctivae redness was observed 1 h after administration with all three animals being scored grade 1 for this reading time point. This effect was fully reversible within 24 h (1/3 animals) or 48 h (2/3 animals), respectively. No effects on iris and cornea opacity were noted in any animal. No further ocular reactions were observed until the end of the study. Mean scores evaluated over 24, 48 and 72 h for chemosis and conjunctivae redness were 0.3, 0.3 and 0.0 for the three animals exposed and 0.0 for iris and cornea opacity for all three animals. In conclusion, the test substance did not exhibit eye-irritating properties in the conducted study.

Justification for classification or non-classification

The available data on skin and eye irritation/corrosion do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.