[No public or meaningful name is available]

Endpoint summary

Description of key information

The test item was found to be non-irritant to skin or eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 h

Score:

0.6

Max. score:

1.5

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24/72 hrs

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24/72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24/72 hours

Score:

1

Max. score:

4

Reversibility:

other: Did not resolve within 72 hours, no further observations were performed

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24/72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24/72 hours

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24/72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 24/72 hours

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: 24/72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: 24/72 hours

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: 24/72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: 24/72 hours

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: 24/72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

See Table 1 for Skin reactions

Other effects:

No data.

Table 1: Individual Skin Reactions

Sex	Animal No.	Erythma		Edema
		Intact site	Abraded site	Intact site	Abraded site
Male	1	1.0	1.0	0	0
	2	1.0	1.0	1.0	1.0
	3	1.0	1.0	0	0
Female	4	1.0	1.5	0	0
	5	1.0	1.0	0	0
	6	1.0	1.0	0	0
Average of 24 -hour		1.0
Average of 72-hour		0.2
Primary Irritation Index		0.6

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: FHSA regulations

Conclusions:

To FHSA regulations, the test material is not a primary skin irritant

Executive summary:

In a primary dermal irritation study in the rabbit male and female animals were dermally exposed to 0.5 ml of the substance for 24 hours. Animals were observed for 72 hours. Irritation was scores by the Draize classification scheme.

No corrosive effects were noted during the study and the substance produced a primary irritation index of 0.6.

The substance is not classified according to the FHSA regulations as non-irritant for skin.

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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.167

Max. score:

4

Reversibility:

other: 72 hour score 0, 96 hour score 0.5.

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Other effects:

None

Table 1. Body Weight Data

	Animal No.	Initiation	Terminal (day 7)
Male	1	2398	2527
	2	2452	2592
	3	2418	2511
Average		2423	2543
Female	4	2403	2482
	5	2501	2409
	6	2332	2333
Average		2412	2408

Table 2. Individual Data for ocular Reactions

Sex		Male			Female
Animal No.		1	2	3	4	5	6
24 h	Cornea -   Opacity -   area	0 0	0 0	0 0	0 0	0 0	0 0
	Iris	0	0	0	0	0	0
	Conjunctivae -   Redness -   Chemosis -   Discharge	0 0.5 0	0 0 0	0 0 0	0 0 0	0.5 0 0	1.0 0 0
48 h	Cornea -   Opacity -   area	0 0	0 0	0 0	0 0	0 0	0 0
	Iris	0	0	0	0	0	0
	Conjunctivae -   Redness -   Chemosis -   Discharge	0 0 0	0 0 0	0 0 0	0 0 0	0.5 0 0	0.5 0 0
72 h	Cornea -   Opacity -   area	0 0	0 0	0 0	0 0	0 0	0 0
	Iris	0	0	0	0	0	0
	Conjunctivae -   Redness -   Chemosis -   Discharge	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	Sodium Fluorescein Examination	-ve	-ve	-ve	-ve	-ve	-ve
96 h	Cornea -   Opacity -   area	0 0	0 0	0 0	0 0	0 0	0 0
	Iris	0	0	0	0	0	0
	Conjunctivae -   Redness -   Chemosis -   Discharge	0 0.5 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
Primary Eye irritation scores		24 h: 0.7 48 h: 0.3 72 h: 0.3 96 h: 0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: FHSA regulations

Conclusions:

Test eyes treated with the substance did not exhibit ocular effects at all time points observed throughout the study. Following assessment of the data for all endpoints, the test material is not a primary eye irritant

Executive summary:

In a study to evaluate the ocular irritancy potential of the substance using New Zealand White strain rabbit. The substance did not cause any ocular effects therefore it is not a primary eye irritant. 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

The test item was evaluated for its irritating properties on skin and eyes of rabbits. It was found to be non-irritant to skin or eyes. The studies are found to be adequate to fufill the purposes of this endpoint.

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of the test material with regard to irritation / corrosion.

The test material is not classified for these endpoints in accordance with the CLP Regulation (EC) No 1272/2008.