Mecoprop

Endpoint summary

Description of key information

Skin Irritation In Vivo: Kirsch (1983)

Under the conditions of this study, the test material was not classified in accordance with EU criteria.

Eye irritation In Vivo: Kirsch (1983)

Under the conditions of this study, the test material was classified in accordance with EU criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Justification for type of information:

An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Fed. Reg. 38, No. 187, Section 1500.41, P.27019

Version / remarks:

Sept. 27, 1973

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Males: 2.97 kg, females: 3.13 kg (mean weights)
- Housing: Cages were made of stainless steel with wire mesh walk floors. Floor area: 40 cm x 51 cm. Animals were housed 1 per cage. No bedding in the cages; sawdust in the waste trays.
- Diet: About 130 g per animal per day
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study in the animal care unit; same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 30 to 70 % relative humidity
- Photoperiod: 12 hours light/ 12 hours dark (06.00 - 18.00 hours/ 18.00 - 06.00 hours)

Type of coverage:

occlusive

Preparation of test site:

other: clipped (intact and abraded)

Vehicle:

water

Remarks:

Distilled water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: Around 0.5 g of test material.

NEGATIVE CONTROL
- Amount(s) applied: Untreated skin sites of the same animals were used as negative controls.

Duration of treatment / exposure:

24 hours

Observation period:

15 days

Number of animals:

2 males and 4 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm on intact and abraded skin. Fur was clipped at least 15 hours before the application of the test material.
- The test patch (2.5 x 2.5 cm) was covered with about a 0.5 mm layer of the 50 % suspension (about 0.5 g of test material).
- Application site: Upper third of the back or flanks.

REMOVAL OF TEST SUBSTANCE
- Test material is wiped off after 24 hours.

OBSERVATION TIME POINTS
- 30 to 60 minutes after removal of the test patches and 48 h, 72 h, 8 d and 15 d after the beginning of the test material application.

SCORING SYSTEM:
- Draize method.

ADDITIONAL EXAMINATIONS
- After sacrifice the animals are examined by gross pathology. If there are clinical signs of necroses, these are confirmed by gross pathological examination after incision of the skin. If there are differences between clinical and pathological findings, only the latter are included in the final report.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

other: abraded skin

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

other: abraded skin

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: abraded skin

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

other: abraded skin

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

other: abraded skin

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

other: abraded skin

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: abraded skin

Summary of Results

Readings	Animal	Intact Skin			Abraded Skin			Individual Irritation Index
		Erythema (E)	Oedema (ED)	Symtpoms	Erythema (E)	Oedema (ED)	Symtpoms
24 hours	1	2	2	-	2	2	HE	4.0
	2	2	2	-	2	3	HE	4.5
	3	2	3	-	2	3	-	5.0
	4	2	1	-	2	1	-	3.0
	5	2	1	-	2	1	-	3.0
	6	2	1	-	2	2	-	3.5
	Mean	2.0	1.7		2.0	2.0		3.8
48 hours	1	2	1	HE	2	2	HE	3.5
	2	2	1	HE	2	2	HE	3.5
	3	2	1	-	2	2		3.5
	4	2	1	-	2	1		3.0
	5	2	1	-	2	1		3.0
	6	2	1	-	2	2		3.5
	Mean	2.0	1.0		2.0	1.7		3.3
72 hours	1	2	1	HE	2	2	HE	3.5
	2	2	1	-	2	2	HE	3.5
	3	2	1	-	2	2		3.5
	4	2	1	-	2	1		3.0
	5	2	0	-	2	1		2.5
	6	2	1	-	2	2	HE	3.5
	Mean	2.0	0.8		2.0	1.7		3.3
8 days	1	1	0	S	1	0	S	1.0
	2	0	0	S	1	0	S	0.5
	3	*	*	S2	*	*	S2	-
	4	1	0	S	1	0	S	1.0
	5	0	0	S	1	0	S	0.5
	6	0	0	-	1	0	S	0.5
	Mean	0.3	0		1.0	0		0.7
15 days	1	0	0	S	0	0	S	0
	2	0	0	S	0	0	S	0
	3	*	*	S2	*	*	S2	-
	4	0	0	S	0	0	S	0
	5	0	0	S	0	0	S	0
	6	0	0	S	0	0	S	0
	Mean	0	0		0	0		0

Primary irritation index =42.5/12 = 3.5

S2 = Death not due to test material

HE = Haemorrhagic

S = Scaling

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study, the test material was not classified in accordance with EU criteria.

Executive summary:

The potential of the test material to cause irritation to the skin of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.41, P.27019, a study similar in design to OECD 404.

Six Vienna white rabbits (two males and four females) were treated with a 50 % w/w aqueous formulation of the test material for 24 hours under an occlusive dressing. The test sites were observed for 15 days following application and assessed using the Draize scale.

Under the conditions of this study, the test material was not classified in accordance with EU criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Justification for type of information:

An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Fed. Reg. 38, No. 187, Section 1500.42, P.27019

Version / remarks:

Sept. 27, 1973

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males: 3.28 kg, females: 2.85 kg (mean weights).
- Housing: Cages were made of stainless steel with wire mesh walk floors. Floor area: 40 x 51 cm. Animals were housed 1 per cage. No bedding in the cages; sawdust in the waste trays.
- Diet: About 130 g per animal per day
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study in the animal care unit; same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 30 to 70 % relative humidity
- Photoperiod: 12 hours light/ 12 hours dark (06.00 - 18.00 hours/ 18.00 - 06.00 hours)

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume (about 54 mg of the comminuted test material)

Duration of treatment / exposure:

The test material was not washed out.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- The test material was not washed out.

SCORING SYSTEM:
- Based on the Draize appraisal.
- Readings were performed at 1, 24, 48 and 72 hours after application.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Summary of Results

Readings	Animal	Cornea		Iris	Conjunctivae			Symptoms	Individual Irritation Index
		Opacity	Area		Redness	Chemosis	Discharge
1 hour	1	1	4	1	2	2	2	PC	37
	2	2	4	1	2	2	3	PC	59
	3	2	4	1	2	2	2	PC	57
	4	1	4	1	2	2	2	-	37
	5	1	4	1	2	2	3	PC	39
	6	2	4	1	2	2	2	PC	57
	Mean								48
24 hours	1	2	4	2	3	2	3	PC/S/RE	66
	2	3	4	2	3	2	2	PC/S/DC	84
	3	2	4	2	3	2	3	PC/S/DC/RE	66
	4	2	4	2	3	2	3	PC/S/DC	66
	5	2	4	2	3	2	3	PC/S/DC	66
	6	2	4	2	3	3	3	PC/S/DC	68
	Mean								69
48 hours	1	2	4	2	3	3	3	PC/S/RE/DC	68
	2	3	4	2	3	3	3	PC/S/DC	88
	3	3	4	2	3	3	2	PC/S/DC/RE	86
	4	2	4	2	3	2	3	PC/S/DC/RE	66
	5	2*	4*	2*	3*	3	3	S1	68
	6	2	4	2	3	3	3	PC/S/DC/RE	68
	Mean								74
72 hours	1	3	4	2	3	3	3	PC/S/RE/DC/S3	88
	2	3*	4*	2*	3*	4	3	S1/S3	90
	3	3	4	2	3	3	3	PC/S/DC/RE/MV/S3	88
	4	3	4	2	3	3	3	PC/S/DC/RE/MV/S3	88
	5	3*	4*	2*	3*	4	3	S1/S3	90
	6	3	4	2	3	3	3	PC/S/DC/RE/MV/S3	88
	Mean								89

1392 / 18 = 77 (rounded to the nearest whole number). Primary irritation index is about 77.

* = If in 1 - 5 animals assessments referring to the same characteristic cannot be made at a particular reading, the mean rounded to the nearest whole number of the values that can be read is inserted instead.

S1 = Irritation index could not be read because of suppuration

S3 = Study discontinued after 72 hours because of severe irritation

DC = Detachment of the cornea

MV = Marginal vascularization of the cornea

PC = Pupil contracted

RE = Small retractions in the eyelids

S = Suppuration

Interpretation of results:

other: EU Category 1, H318: Causes serious eye damage

Conclusions:

Under the conditions of this study, the test material was classified in accordance with EU criteria.

Executive summary:

The potential of the test material to cause irritation to the eyes of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.42, P.27019, a study similar in design to OECD 405.

Six Vienna white rabbits (three males and three females) were treated with an application of 0.1 mL (~54 mg) of test material into the conjunctival sac of the right eyelid. The untreated eye served as a negative control. The eyes were observed for 72 hours following application and assessed using the Draize scale.

Under the conditions of this study, the test material was classified.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation In Vivo: Kirsch (1983)

The potential of the test material to cause irritation to the skin of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.41, P.27019, a study similar in design to OECD 404. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

Six Vienna white rabbits (two males and four females) were treated with a 50 % w/w aqueous formulation of the test material for 24 hours under an occlusive dressing. The test sites were observed for 15 days following application and assessed using the Draize scale.

Under the conditions of this study, the test material was not classified in accordance with EU criteria.

 

Skin Irritation In Vitro: Waiver

An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.

 

Eye Irritation In Vivo: Kirsch (1983)

The potential of the test material to cause irritation to the eyes of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.42, P.27019, a study similar in design to OECD 405. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

Six Vienna white rabbits (three males and three females) were treated with an application of 0.1 mL (~54 mg) of test material into the conjunctival sac of the right eyelid. The untreated eye served as a negative control. The eyes were observed for 72 hours following application and assessed using the Draize scale.

Under the conditions of this study, the test material was classified in accordance with EU criteria.

 

Eye Irritation In Vitro: Waiver

An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin irritation but does require classification with respect to eye irritation (EU Category 1, H318: Causes serious eye damage).

In accordance with Annex VI of Regulation (EC) No 1272/2008, the substance has a harmonised classification for skin irritation (EU Category 2, H315: Causes skin irritation).