(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

Endpoint summary

Description of key information

Epoxiconazole was non-irritant in the OECD 404 skin irritation study in White Vienna rabbits. This also holds true for eye irritation under OECD 405 test conditions.

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:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach (Main)
- Age at study initiation: not specified
- Weight at study initiation: female: 2.37kg
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area 40x51 cm; single
- Diet (e.g. ad libitum): Kliba 341, 4MM, Klingentalmuehle AG, 130g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the suspension
- Concentration (if solution):50% aqueous formulation

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure:upper third of the back or flanks
- % coverage: semi-occlussive
- Type of wrap if used: porous dressing (four layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period with Lutrol and Lutrol/water (1:1)
- Time after start of exposure:4h

SCORING SYSTEM:
Erythema and edema:
0=none
1=very slight
2=well-defined
3=moderate to severe
4= severe to very severe

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

None of the animals showed erythema or edema.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions the substance does not show a skin irritating potential.

Executive summary:

The substance was tested for its skin irritating potential. The test method was based on EPA (FIFRA) and OECD 404 guidelines. GLP requirements were fulfilled. Approx. 0.5g of a 50% aqueous suspension of the test substance was applied to the intact dorsal skin of 6 female white Vienna rabbits each under a semi-occlusive dressing for 4 hours. After the patches were removed the treated area was rinsed with Lutrol and Lutro/water (1:1).

No signs of irritation were observed after application.

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:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

May 1981

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Version / remarks:

Nov 1982

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach (Main)
- Age at study initiation:
- Weight at study initiation: male: 3.10kg, female: 2.99kg
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area 40x51 cm
- Diet (e.g. ad libitum): Kliba 341, 4MM, Klingentalmuehle AG, 130g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 10-24°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml bulk volume (about 31 mg of the comminuted test substance)
- Concentration (if solution):

Duration of treatment / exposure:

Single application of the conjunctival sac of the right eyelid. The substance was not washed out.

Observation period (in vivo):

72 h. Readings at 1 h, 24 h, 48 h, and 72 h

Number of animals or in vitro replicates:

3 male and 3 female animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM:
Scale for scoring ocular lesions:
Chemosis and cornea opacity: 0=none, 1=well-defined, 2=severe, 4= very severe
Conjunctivae redness: 0=normal, 1=slight, 2=well-defined, 3=severe
Iris: 0=normal, 1=circum-corneal injection, 2=iritis
Discharge: 0=normal, 1=slightly increased, 2=clearly increased, 3=distinctly increased

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72h

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72h

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Table 1: Results acute eye irritation

 

 

Readings	Animal	Sex	Cornea		Iris	Conjunctiva			Symptoms
			OP	AR		Red	Sw	DI
1 h	1 2 3 4 5 6	F M M F M F	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	1 1 1 1 0 0	0 0 0 0 0 0	0 1 1 1 1 1
24 h	1 2 3 4 5 6	F M M F M F	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	2 1 2 2 0 0	0 0 0 0 0 0	0 1 0 0 0 0
48 h	1 2 3 4 5 6	F M M F M F	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	1 1 1 1 0 0	0 0 0 0 0 0	0 1 0 0 0 0
72 h	1 2 3 4 5 6	F M M F M F	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0
Mean	1 2 3 4 5 6	F M M F M F	0.0 0.0 0.0 0.0 0.0 0.0		0.0 0.0 0.0 0.0 0.0 0.0	1.0 0.7 1.0 1.0 0.0 0.0	0.0 0.0 0.0 0.0 0.0 0.0
Mean			0.0		0.0	0.6	0.0

           OP=Opacity-degree of density; Sw=Chemosis; AR=Area of cornea involved; DI=Discharge; Red=Conjunctivae redness

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test item does not show eye irritating properties and has not to be classified for eye irritation.

Executive summary:

The substance was tested for its eye irritating potenital. The test method was based on EPA (FIFRA) and OECD 405 guidelines. GLP requirements were fulfilled. 0.1ml of the comminuted test substance was applied once to the eyes of 3 male and 3 female white Vienna rabbits. 1 hour after applciation slight redness and slightly increased discharge of the conjunctivae occurred. The symptoms were observed for a period of 48h. After 72h the reversibility could be demonstrated.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The available data on irritation endpoints does not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.