Registration Dossier

Administrative data

Description of key information

Based on results with the read-across substance, the test item is not considered to be irritating to skin or eye.

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:
The read-across is considered appropriate since the source and target substance consist of the same constituents at different proportions. The main constituent 1-(carboxymethyl)-dimethylpyridinium present at a concentration of ca. 22 % in the source substance caused no adverse effects in the respective toxicological endpoints. Thus, 1-(carboxymethyl)-dimethylpyridinium at 55 % as present in the target substance is not expected to cause adverse effects with regard to skin and eye irritation and acute oral toxicity. Other constituents, i. e. sodium acetate, sodium chloride and water, are not considered relevant in regards to local effects and or acute oral toxicity, since none of these require classification regarding these endpoints according to CLP.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
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:
The read-across is considered appropriate since the source and target substance consist of the same constituents at different proportions. The main constituent 1-(carboxymethyl)-dimethylpyridinium present at a concentration of ca. 22 % in the source substance caused no adverse effects in the respective toxicological endpoints. Thus, 1-(carboxymethyl)-dimethylpyridinium at 55 % as present in the target substance is not expected to cause adverse effects with regard to skin and eye irritation and acute oral toxicity. Other constituents, i. e. sodium acetate, sodium chloride and water, are not considered relevant in regards to local effects and or acute oral toxicity, since none of these require classification regarding these endpoints according to CLP.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin and eye irritating properties of the test item are assessed by applying a read-across approach to CAS 85168 -84 -9. Read-across is considered suitable and reliable based on the following justification:

The read-across is considered appropriate since the source and target substance consist of the same constituents at different proportions. The main constituent 1-(carboxymethyl)-dimethylpyridinium present at a concentration of ca. 22 % in the source substance caused no adverse effects in the respective toxicological endpoints. Thus, 1-(carboxymethyl)-methylpyridinium at 55 %, as present in the target substance, is not expected to cause adverse effects with regard to skin and eye irritation or acute oral toxicity. Other constituents, i. e. sodium acetate, sodium chloride and water, are not considered relevant in regards to local effects and or acute oral toxicity, since none of these require classification regarding these endpoints according to CLP.

Skin irritation in vivo with read-across substance CAS 85168 -84 -9

The study was carried out in order to assess the irritancy potential of a test material following a single 4-hour semi-occluded application to the intact rabbit skin. The study was designed to comply with the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No.404 "Acute Dermal Irritation/Corrosion". The test system was chosen because the rabbit has been shown to be a suitable model for this type of study and is recommended by the test method. Three New Zealand White rabbits were exposed to the test item on the clipped skin under semiocclusive dressing. After 4 h the test item was removed by gentle washing. Skin was inspected for local irritaion symptons directly after removing the test item and after 24, 48, and 72 h. No signs of skin irritation were noted during the study period. Therefore, the test item is considered to be not irritating to rabbit skin.

Eye irritation in vivo with read-across substance CAS 85168 -84 -9

The study was performed in order to assess irritancy potential of a test material following a single application to the rabbit eye. The study was designed to comply with the recommendations of the OECD Guidelines for Testing Chemicals (1981) No. 405 "Acute Eye Irritation /Corrosion". Three New Zealand White rabbits were administered 0.1 mL of the unchanged test item in the right eye. The contralateral left eye of the same animal served as negative control. Eyes were examined 1, 24, 48 and 72 h after application and findings were scored according to Draize scoring system. Based on the findings in this study the test item is not considered to be irritating to rabbit eye.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data of the read-across substance are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data the test item does not require classification as skin or eye irriating/corrosive according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.