Registration Dossier

Administrative data

Description of key information

Skin irritation: Based on the read-across approach from the analogue substance OS1600, OS2600 was determined to be not irritating to the skin.

Eye irritation: Based on the read-across approach from the analogue substance MPKO, OS2600 was determined to be irritating to the 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (KIimish = 1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format.
Reason / purpose:
read-across source
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Based on a read-across from an analogue substance.

The data matrix is included in the reporting format attached.

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the read-across approach from the analogue substance OS1600, OS2600 was determined to be not irritating to the skin.
Executive summary:

The skin irritation test was performed on the analogue substance OS1600 in accordance with OECD Guideline 404. The mean of scores for these reactions at approximately 24, 48 and 72 hours after the end of administration were Erythema score 1 and Oedema score 0 in all three animals, therefore, the test substance was considered to be not irritating to the skin. Based on these results, the read-across approach was applied and the substance OS2600 was also determined to be not irritating to the 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (KIimish = 1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format and read-across rationale.
Reason / purpose:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Based on a read-across from an analogue substance.

The data matrix is included in the reporting format attached

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on the read-across approach from the analogue substance MPKO, OS2600 was determined to be irritating to the eyes.
Executive summary:

An acute eye irritation/corrosion study was performed with the analogue substance MPKO in rabbit according to OECD Guideline 405. Based on the read-across approach OS2600 was determined to be irritating to the eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Key study: Read-across approach from experimental data on the analogue substance OS1600: A skin irritation test was performed in accordance with OECD Guideline 404 (GLP study). Three rabbits received a single four hour, semi-occlusive, dermal administration of approximately 0.5 mL of the test substance as supplied and were observed for seven or nine days. The means of scores for these reactions at approximately 24, 48 and 72 hours after the end of administration were Erythema score 1 (fully reversible) and Oedema score 0 in all three animals. Based on these results, the substance OS2600 was determined to be not irritating to the skin.

Eye irritation:

Key study: Read-across approach from experimental results on the analogue substance MPKO: An acute eye irritation/corrosion study was performed in rabbit according to OECD Guideline 405 (GLP study). Based on the read-across approach from the experimental data on the analogue substance MPKO, the hydrolysis product of OS2600 (irritating to the eye based on the following mean 24 -72 h scores for each animal: Corneal opacity: 0, 1.0, 1.0; Iris: 0, 0.7, 0.7; Redness: 0,7, 2.3, 2.0; Chemosis: 0.3, 1.3, 1.3, with all the effects reversible by day 14), the substance OS2600 was determined also to be irritating to the eyes.

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation: Based on the read across, OS2600 is considered to be not irritating to the skin in accordance with CLP Regulation EU No. 1272/2008, since no mean value ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema was observed in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal.

Eye irritation: Based on the read across, OS2600 is classified as Eye damage Category 2, H319in accordance with CLP Regulation EU No. 1272/2008, since a positive response of conjunctival redness ≥ 2 (fully reversible) was observed in 2 of 3 tested animals as the mean scores following grading at 24, 48 and 72 hours after installation.