Registration Dossier

Administrative data

Description of key information

Disodium persulfate was tested for skin irritation in rabbits. According to the results disodium persulfate showed no skin irritation effects in these tests. However, human case data indicated skin irritation properties. Disodium persulfate was tested for eye irritation in rabbits. Based on the results obtained, disodium persulfate was considered not irritating to eyes of rabbits. However, as for skin irritation human data indicated that persulfates induce eye irritation. Additional animal studies were available for substances of the Persulfate Category. Using a read-across approach from data available for diammonium persulfate, disodium persulfate was considered respiratory tract irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 2 weeks
Remarks on result:
other: test was performed on scarified skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.89
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: test was performed on scarified skin
Endpoint:
skin corrosion: 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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
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
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

All substances of the Persulfate Category share the same anionic persulfate moiety and similar toxicological properties. Diammonium persulfate, dipotassium persulfate and disodium persulfate were tested in animal studies for skin irritation/corrosion and eye irritation and diammonium persulfate was examined for respiratory irritation in a subchronic inhalation toxicity study. Additionally, human data was available for dipotassium persulfate and diammonium persulfate.

Disodium persulfate was tested for skin irritation to rabbits and showed no signs of irritation or corrosion when applied to the rabbit skin. However, human case data with substances of the Persulfate Category revealed skin irritation properties.

Disodium persulfate was tested for eye irritation in rabbits. Based on the results obtained, disodium persulfate was considered not irritating to eyes of rabbits. However, human case data with substances of the Persulfate Category revealed eye irritation properties.

Using a read-across approach from data available for diammonium persulfate, disodium persulfate was considered respiratory tract irritant.

For the Persulfate Category worst-case results were considered for safety assessment:

Skin irritation: irritating

Eye irritation: irritating

Respiratory irritation: irritating

Justification for classification or non-classification

Based on animal test results and human case study data, substances of the Persulfate Category were classified and labelled as eye irritant, cat. 2 H319 (causes serious eye irritation), skin irritant cat. 2 H315 (causes skin irritation) and respiratory tract irritant cat. 3 STOT SE. 3 H335 (causes respiratory tract irritation) according to Regulation 1272/2008/EC (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.