Registration Dossier
Registration Dossier
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EC number: 231-892-1 | CAS number: 7775-27-1
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 1983-04-08
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- 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
- Details on test material:
- - Name of test material (as cited in study report): disodium peroxodisulfate
- Physical state: crystalline, white powder
- Analytical purity: > 99%
- Storage condition of test material: room temperature
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, D-4791 Borchen
- Age at study initiation: male: 5 - 10 weeks; female: 6 - 7 weeks
- Weight at study initiation: male: 314 - 485 g; female: 330 - 387 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
- 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:
- control group: 20 animals (10 male, 10 female)
application: 0.1 ml of 0.1% test-solution - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no positive control
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 9
- Total no. in group:
- 19
- Clinical observations:
- Erythema; Oedema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 11
- Total no. in group:
- 19
- Clinical observations:
- Erythema; Oedema
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- Erythema, Oedema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Clinical observations:
- Erythema; Oedema
- Key result
- 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 this study, the test material disodium persulfate was sensitizing when applied to Pirbright White guinea pigs.
Disodium persulfate was classified as skin sensitiser cat. 1 H317 (may cause an allergic skin reaction) according to Regulation 1271/2008/EC (CLP) - Executive summary:
Disodium persulfate was tested for skin sensitization properties in Guinea pigs according to OECD Guideline 406. At the second reading after (topical) challenge erythema and sporadical oedema were observed at 11 test animals compared to only 1 control animal who revealed slight erythema and oedema. Under the conditions of this study, the test material disodium persulfate was considered sensitizing when applied to guinea pigs. No systemic-toxic effects were verifiable.
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