Diammonium peroxodisulphate

Endpoint summary

Description of key information

Diammonium persulfate was tested for skin irritation in rabbits in three studies. According to these studies, diammonium persulfate showed no skin irritation to intact skin. However, on abraded skin the test item showed severe skin irritation. Diammonium persulfate was tested for eye irritation in rabbits in two studies. Diammonium persulfate was considered to be slightly irritating to the eye in one study, while in the second study diammonium was not irritating to eyes. Diammonium persulfate was considered as eye and skin irritant based on human case studies. Based on results of a subchronic inhalation toxicity study diammonium persulfate revealed respiratory irritation properties. Additional studies were available for substances of the Persulfate Category, dipotassium persulfate and disodium persulfate.  

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-03-02 to 1983-03-16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study.

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

no

Species:

rabbit

Strain:

other: Albino - White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): standardised test animal feed, Altromin
- Water (e.g. ad libitum): ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 1°C
- Humidity (%): 50 - 60 %
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g of the test substance.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 h

Number of animals:

3

Details on study design:

NA

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

No systemic-toxic effects occurred after treatment with the test material. All animals remained healthy throughout the study.

Other effects:

NA

No remarks

Interpretation of results:

GHS criteria not met

Conclusions:

Under conditions of the study, diammonium Persulfate revealed no skin irritating properties.

Executive summary:

Diammonium persulfate was applied in a single dose of 0.5 g diammonium persulfate to intact skin of albino rabbits. One hour after the end of the exposure period the three rabbits had slight erythema which disappeared at the time of the study observation time points after 24 and 48 hours. None of the animals reach an average erythema or edema score equal or above 2. The highest score (edema score) was 0.33 obtained in one of the three rabbits. Under the conditions of the study diammonium persulfate was not considered irritating to skin. Additionally, no systemic-toxic effects occured after treatment with the test material. All animals remained healthy throughout the study.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-03-08 to 1983-03-29

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Principles of method if other than guideline:

NA

GLP compliance:

no

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.0 - 2.1 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): standardised test animal feed, Altromin
- Water (e.g. ad libitum): ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 1°C
- Humidity (%): 55 % ± 5 %
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

A total volume of 0.1 mL of the test item was used for the study in pure state, in a single dose

Duration of treatment / exposure:

NA

Observation period (in vivo):

The eyes were examined at 1 hour, 24, 48 and 72 hours after the treatment. The duration of the observation period was sufficient for the statement of reversibility or irreversibility of changes.
All of the observations were performed using a hand slit lamp.

Number of animals or in vitro replicates:

3 animals

Details on study design:

NA

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 hours

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: 2 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The determined irritating index was 10.5.

Other effects:

No other effects.

No remarks

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study and the study criteria, diammonium persulfate was not considered eye irritating.

Executive summary:

Diammonium persulfate was tested for eye irritation properties in rabbits according to OECD guideline 405. 0.1 mL of the test item was placed into the conjunctival sac of one eye of the animals. The untreated eye served as control. One hour after application cornea irritation and diffuse areas of opacity was observed in one of the three animals. Conjunctival redness, obvious swelling with partial eversion of lids plus hypersecretion were observed in one animal, one hour after application. 72 hours after application full recovery was observed. The determined irritating index was 10.5. Under the conditions of this study diammonium persulfate was considered to be slightly irritating to eyes. No systemic-toxic effects were observed and the general state of the animals was good throughout the study period.

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.

Diammonium persulfate was tested for skin irritation in rabbits in three studies. According to these studies, diammonium persulfate showed no skin irritation to intact skin. However, on abraded skin the test item showed severe skin irritation.

Diammonium persulfate was tested for eye irritation in rabbits in a study according to OECD guideline 405. In this study, diammonium persulfate was shown to be slightly irritating. In a second study, diammonium persulfate was tested for eye irritation in rabbits according to guideline EPA OPP 81-4 and revealed no eye irritation effects. However, human case data revealed eye irritant properties.

Indications for respiratory tract irritation were observed in subchronic (13 weeks) whole-body inhalation toxicity study with diammonium persulfate in Sprague-Dawley rats. At respirable dust concentrations of 0, 0.5, 10.3 and 25 mg/m³ irritation of the trachea and bronchi was noted microscopically at concentrations of 25 mg/m³.

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

The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on animal test results and human case study data, substances of the Persulfate Category were classified 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 (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.