Registration Dossier
Registration Dossier
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EC number: 231-781-8 | CAS number: 7727-21-1
Skin sensitisation
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- 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.
Test material
- Reference substance name:
- Diammonium peroxodisulphate
- EC Number:
- 231-786-5
- EC Name:
- Diammonium peroxodisulphate
- Cas Number:
- 7727-54-0
- Molecular formula:
- H3N.1/2H2O8S2
- IUPAC Name:
- diammonium [(sulfonatoperoxy)sulfonyl]oxidanide
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- 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 ± 2 °C
- Humidity (%): 60 ± 10 %
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 %
Challenge
- 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) - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no positive control
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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 sensitising 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, compare 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.
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