Diammonium peroxodisulphate

Endpoint summary

Description of key information

Diammonium persulfate was tested for skin sensitising properties in guinea pigs and in a local lymph node assay (LLNA). Results of both studies indicated that diammonium persulfate has a skin sensitisation potential. Furthermore, human data indicated of skin sensitising potential for diammonium persulfate. Additional studies were available for substances of the Persulfate Category, dipotassium persulfate and disodium persulfate.

Results from human studies indicated that diammonium persulfate was capable of inducing respiratory tract sensitisation in occupationally exposed individuals. Additional human studies were available for substances of the Persulfate Category, dipotassium persulfate and disodium persulfate.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-02-14 to 1985-06-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non GLP study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

1981

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

no

Type of study:

Freund's complete adjuvant test

Justification for non-LLNA method:

Study was performed before LLNA-method was described as OECD test guideline and before it could be established in the EU-REACH regulation.

Species:

guinea pig

Strain:

other: Pirbright White

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, 4791 Borchen, Germany
- Age at study initiation: male: 7 - 10 weeks; female: 5 - 8 weeks
- Weight at study initiation: male: 310 - 468 g; female: 310 - 416 g
- Housing: individually in cages
- Diet (e.g. ad libitum): standardised test animal feed, Altromin; ad libitum
- Water (e.g. ad libitum): tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C ± 2°C
- Humidity (%): 60 % ± 10 %
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1%

Route:

other: intradermal and epidermal/ occlusive

Vehicle:

physiological saline

Concentration / amount:

0.1%

No. of animals per dose:

20 (test group)
20 (control group)

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: -
- Test groups: test substance (TS) in FCA
- Control group: only FCA
- Site: right flank, back, neck
- Frequency of applications: day 1., 3., 5. (test material)
day 8., 12., 15., 17., 19. (test material plus Freunds complete adjuvant)
- Duration: 0 - 19 d
- Concentrations: 0.1 % , same throughout


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 36. and 50
- Exposure period: -
- Test groups: TS
- Control group: TS
- Site: right flank, back
- Concentrations: 0.1 % and 1 %
- Evaluation (hr after challenge): day 37 (24 hours after application); day 52 and 53 (24 and 48 hours after patch removal)

Challenge controls:

NA

Positive control substance(s):

no

Positive control results:

no positive control

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1 %

No. with + reactions:

14

Total no. in group:

20

Clinical observations:

Erythema; Edema

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1 %

No. with + reactions:

14

Total no. in group:

20

Clinical observations:

Erythema; Edema

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

1 %

No. with + reactions:

3

Total no. in group:

20

Clinical observations:

Erythema; Edema

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

1 %

No. with + reactions:

1

Total no. in group:

20

Clinical observations:

Erythema; Edema

Group:

positive control

Remarks on result:

not measured/tested

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

Under the conditions of the study, diammonium persulfate was sensitizing when applied to guinea pigs. Thus, diammonium persulfate was classified as skin sensitiser.

Executive summary:

Diammonium persulfate was tested for skin sensitizing properties in Guinea pigs according to OECD guideline 406. After challenge, erythema and oedema were observed in 16 of 20 guinea pigs in the test group, compared to only 3 control animals that revealed slight erythema. All animals remained healthy and gained weight during the study. Under the conditions of this study, the test material diammonium persulfate was considered sensitizing.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Diammonium persulfate was tested for skin sensitising properties in guinea pigs according to OECD guideline no. 406 (GPMT). After challenge, erythema and oedema were observed in 16 of 20 guinea pigs in the test group, compared to only 3 control animals that revealed slight erythema. All animals remained healthy and gained weight during the study. Under the conditions of this study, the test material diammonium persulfate was considered sensitizing. Diammonium persulfate was tested for skin sensitising potential in the mouse local lymph node assay (LLNA). Exposure to diammonium persulfate resulted in a maximal mean SI of 6.8 +/- 1.8 at the highest concentration tested (5 %). From the calculated SI values, the estimated EC3 value for diammonium persulfate was 1.9 %. Based on the EC3 value, diammonium persulfate was classified in the study as a moderate skin sensitizer. Additionally, human data (epidemiological studies and case reports) showed that diammonium persulfate is capable of inducing skin sensitisation.

Of the Persulfate Category, diammonium persulfate, dipotassium persulfate and disodium persulfate were tested in animal studies for skin sensitisation. Diammonium persulfate revealed skin sensitisation properties in a GPMT as well as in a LLNA. Skin sensitisation potential was implied by results of LLNA for dipotassium persulfate. Disodium persulfate revealed skin sensitisation properties in one of the two GPMT and a skin sensitisation potential in a LLNA . Additionally, human data (epidemiological studies and case reports) were available for diammonium persulfate, dipotassium persulfate and disodium persulfate showing skin sensitisation potential in occupationally exposed individuals for all of the three persulfate salts.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Results of human data (epidemiological studies and case reports) indicated that diammonium persulfate was capable of inducing respiratory tract sensitisation in occupationally exposed individuals.

Human data was available for diammonium persulfate, dipotassium persulfate and disodium persulfate of the Persulfate Category. Epidemiological studies and case reports showed respiratory sensitisation potential in occupationally exposed individuals for all the three salts of the Persulfate Category. Thus, for the Persulfate Category, for safety assessment:

Justification for classification or non-classification

The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the available data on skin sensitisation, the substances of the Persulfate Category were classified as skin sensitiser, cat. 1 H317 (may cause an allergic skin reaction) and respiratory sensitisation, cat. 1 H334 (may cause allergy or asthma symptoms or breathing difficulties if inhaled) according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.