Registration Dossier

Administrative data

Description of key information

The read-across substance was not irritating and not corrosive to rabbit skin (reference 7.3.1 -1).

The read-across substance was not irritating to the rabbit eye (reference 7.3.2 -1).

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
Justification for type of information:
Please refer to section 13 for the read-across justification.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
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
Justification for type of information:
Please refer to section 13 for the read-across justification.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

 

No study data with the test item is available for skin irritation. Therefore, a read-across to the read-across substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the skin irritation potential of the test item.

 

To identify the skin irritation/corrosion potential the read-across substance was applied to the intact skin of three female rabbits for a 4 hours period under semiocclusive conditions. Therefore, the read-across substance was mixed with some drops of Aqua pro injectione to ensure good contact to the skin. After removal of the patches the remaining read-across substance was wiped off. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then, examinations were performed daily for further 7 days. The evaluation of all animals yields a zero mean score for both edema and erythema. Therefore, under the conditions of the study according to OECD 404 no signs of skin irritation were detected.

Eye irritation

No study data with the test item is available for eye irritation. Therefore, a read-across to the read-across substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the eye irritation potential of the test item.

An in vivo study in rabbits according to OECD 405 was conducted to evaluate the eye irritation potential of the read-across substance. Therefore, 0.1 g of the ground read-across substance was applied into the conjunctival sac of the left eye of 3 rabbits while the right untreated eye served as control. The first examination of the eyes followed 1 hour after instillation. The examinations were performed daily for further 7 days. No signs of irritation were observed at the cornea and iris. The conjunctivae showed redness (score 1) 1 hour after application. Afterwards, all scores returned to 0 and the effect was fully reversible within the first 24 hours after treatment. The untreated eyes were unchanged. Based on the observations the read-across substance has not to be regarded as an irritant for the eyes.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for skin irritation/corrosion are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is considered to be not classified for skin irritation or corrosion under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EC) 2019/521.

The available data for eye irritation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is considered to be not classified for causing serious eye damage or irritation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EC) 2019/521.